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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004550-18 | EudraCT Number |
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A study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous (SC) administration of TEV-48125 in adult participants with chronic migraine (CM) or episodic migraine (EM). Participants with CM or EM who complete the pivotal efficacy studies of TEV-48125 (TV48125-CNS-30049 [NCT02621931] and TV48125-CNS-30050 [NCT02629861]) and agree to participate in this study; and new participants meeting eligibility criteria (not rolling over from pivotal studies), will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEV-48125 225 mg Monthly: New/Placebo Rollover Participants | Experimental | Participants with CM who were randomized to the placebo treatment group or participants who do not rollover from the pivotal efficacy study, will receive fremanezumab 675 milligrams (mg) SC as loading dose (3 injections of fremanezumab 225 mg/1.5 milliliters [mL] on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who do not rollover from the pivotal efficacy study, will receive 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
|
| TEV-48125 225 mg Monthly: Active Rollover Participants | Experimental | Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, will receive fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, will receive 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
|
| TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fremanezumab | Drug | Fremanezumab will be administered as per the dose and schedule specified in the respective arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE was defined as inability to carry out usual activities. Treatment-related AEs were defined as AEs with possible, probable, definite, or missing relationship to study drug. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Baseline (Day 0) up to follow-up visit (Day 533) |
| Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results | Potentially clinically significant abnormal serum chemistry findings included: Blood Urea Nitrogen (BUN): greater than or equal to (>=) 10.71 millimoles/liter (mmol/L), creatinine: >=177 micromoles/liter (µmol/L), bilirubin: >=34.2 µmol/L, Alanine Aminotransferase (ALT) (units/liter [U/L]): >=3*upper limit of normal (ULN) Aspartate Aminotransferase (AST) (U/L): >=3*ULN, and Gamma Glutamyl Transferase (GGT) (U/L): >=3*ULN. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Baseline (Day 0) up to end of treatment (EOT) visit (Day 336) |
| Number of Participants With Potentially Clinically Significant Abnormal Hematology Results | Potentially clinically significant abnormal hematology findings included: hemoglobin: less than (<) 115 grams/liter (g/L) (in males) or less than or equal to (<=) 95 g/L (in females), hematocrit: <0.37 L/L (in male) or <0.32 L/L (in female), leukocytes: >=20*10^9/L or <=3*10^9/L, eosinophils/leukocytes: >=10%, and platelets: >=700*10^9/L or <=75*10^9/L. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Baseline (Day 0) up to EOT visit (Day 336) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period at Month 12 | A migraine day was defined as when at least 1 of the following situations occurred: A calendar day(0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for migraine with or without aura; a calendar day(0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was missing; a calendar day(0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in e-diary over relevant period)*28. Change was calculated as post-baseline value - baseline value. |
Inclusion Criteria:
Participants Rolling Over from the Pivotal Efficacy Studies:
Participant must have signed and dated the informed consent document.
Participant must have completed the pivotal efficacy study without major protocol violations.
Participants Not Rolling Over from the Pivotal Efficacy Studies:
Males or females aged 18 to 70 years, inclusive, with migraine onset at less than or equal to (≤) 50 years of age.
Participant signed and dated the informed consent document.
Participant has a history of migraine or clinical judgment suggests a migraine diagnosis.
Participant fulfills the criteria for EM or CM with prospectively collected baseline information during the 28-day run-in period.
Body mass index (BMI) of 17.5 to 37.5 kilograms/square meter (kg/m^2) and a total body weight between 45 and 120 kg, inclusive.
All participants must be of non-childbearing potential.
Female participants of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-HCG) pregnancy test prior at screening (confirmed by urine dipstick β-HCG pregnancy test at baseline).
The participant must be willing and able to comply with study restrictions, to remain at the clinic for the required duration during the study period, and to return to the clinic for the follow-up evaluation.
Exclusion Criteria:
Participants Rolling Over from the Pivotal Efficacy Studies:
Pregnant or nursing females
Compliance with daily diary entry lower than 75 percent (%) at the last month of the double-blind treatment period of the pivotal efficacy study.
Participants Not Rolling Over from the Pivotal Efficacy Studies:
Clinically significant findings at the discretion of the investigator.
Evidence or medical history of clinically significant psychiatric issues, including any suicide attempt in the past, or suicidal ideation with a specific plan in the past 2 years.
History of clinically significant cardiovascular disease or vascular ischemia (such as myocardial, neurological [for example; cerebral ischemia], peripheral extremity ischemia, or other ischemic event) or thromboembolic events (arterial or venous thrombotic or embolic events) such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism -Known infection or history of human immunodeficiency virus, tuberculosis, or chronic hepatitis B or C infection.
Past or current history of cancer in the past 5 years, except for appropriately treated nonmelanoma skin carcinoma.
Pregnant or nursing females.
History of hypersensitivity reactions to injected proteins, including monoclonal antibodies.
Participation in a clinical study of a new chemical entity or a prescription medicine within 2 months before study drug administration or 5 half-lives, whichever is longer.
History of alcohol or drug abuse during the past 2 years, or alcohol or drug dependence during the past 5 years.
The participant cannot participate or successfully complete the study, in the opinion of their healthcare provider or the investigator, for any of the following reasons:
Participant is a study center or sponsor employee who is directly involved in the study or the relative of such an employee.
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| Name | Affiliation | Role |
|---|---|---|
| Teva Medical Expert, MD | Teva Branded Pharmaceutical Products R&D, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 13628 | Birmingham | Alabama | 35211 | United States | ||
| Teva Investigational Site 13577 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32913018 | Derived | Goadsby PJ, Silberstein SD, Yeung PP, Cohen JM, Ning X, Yang R, Dodick DW. Long-term safety, tolerability, and efficacy of fremanezumab in migraine: A randomized study. Neurology. 2020 Nov 3;95(18):e2487-e2499. doi: 10.1212/WNL.0000000000010600. Epub 2020 Sep 10. | |
| 32887548 | Derived | Buse DC, Gandhi SK, Cohen JM, Ramirez-Campos V, Cloud B, Yang R, Cowan RP. Improvements across a range of patient-reported domains with fremanezumab treatment: results from a patient survey study. J Headache Pain. 2020 Sep 4;21(1):109. doi: 10.1186/s10194-020-01177-4. |
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A total of 1890 participants were enrolled, including 917 participants with CM rolled over from Study TV48125-CNS-30049, 661 participants with EM rolled over from Study TV48125-CNS-30050, and 312 newly enrolled participants (193 with CM and 119 with EM).
Participants with chronic or episodic migraine (CM or EM) who completed the pivotal efficacy studies of fremanezumab (TV48125-CNS-30049 [NCT02621931] and TV48125-CNS-30050 [NCT02629861]) and agreed to participate in this study; and new participants meeting eligibility criteria (not rolling over from pivotal studies), were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | TEV-48125 225 mg Monthly: New/Placebo Rollover Participants | Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab (TEV-48125) 675 milligrams (mg) subcutaneously (SC) as loading dose (3 injections of fremanezumab 225 mg/1.5 milliliters [mL] on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 30, 2016 | Jun 5, 2019 |
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| Experimental |
Participants with CM or EM who were randomized to the placebo treatment group or participants who do not rollover from the pivotal efficacy study, will receive fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
|
| TEV-48125 675 mg Quarterly: Active Rollover Participants | Experimental | Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, will receive fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
|
|
| Placebo | Drug | Placebo matching to fremanezumab will be administered as per schedule specified in the respective arms. |
|
| Number of Participants With Potentially Clinically Significant Abnormal Urinalysis Laboratory Tests Results | Potentially clinically significant abnormal urinalysis findings included: blood: >=2 unit increase from baseline, urine glucose (milligrams/decilitre [mg/dL]): >=2 unit increase from baseline, ketones (mg/dL): >=2 unit increase from baseline, urine protein (mg/dL): >=2 unit increase from baseline. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Baseline (Day 0) up to EOT visit (Day 336) |
| Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values | Potentially clinically significant abnormal vital signs findings included: pulse rate: <=50 beats/minute (bpm) and decrease of >=15 bpm, or >=120 bpm and increase of >=15 bpm; systolic blood pressure: <=90 millimeters of mercury (mmHg) and decrease of >=20 mmHg, or >=180 mmHg and increase of >=20 mmHg; diastolic blood pressure: <=50 mmHg and decrease of >=15 mmHg or >=105 mmHg and increase of >=15 mmHg; respiratory rate: <10 breaths/minute; and body temperature >=38.3 degrees centigrade and change of >=1.1 degrees centigrade. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Baseline (Day 0) up to EOT visit (Day 336) |
| Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters | ECG parameters included: heart rate, PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF), QT interval corrected using the Bazett's formula (QTcB) and RR interval. Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Baseline (Day 0), endpoint (Day 336) |
| Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results | Coagulation parameters included: prothrombin time (PT) (seconds), prothrombin international normalized ratio (INR), activated partial thromboplastin time (aPTT) (seconds). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Shifts from baseline to endpoint were summarized using participant counts grouped into three categories: - Low (below normal range) - Normal (within the normal range of 9.4 to 12.5 seconds) - High (above normal range). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Baseline (Day 0), endpoint (Day 336) |
| Number of Participants With Injection Site Reactions | Number of participants who reported treatment-emergent injection site reactions are summarized. Preferred terms from MedDRA version 18.1 were offered without a threshold applied. Injection site reactions included injection site induration, pain, erythema, haemorrhage, pruritus, swelling, bruising, rash, urticaria, warmth, dermatitis, haematoma, inflammation, discolouration, discomfort, hypersensitivity, hypoaesthesia, irritation, oedema, papule, paraesthesia, vesicles and pallor. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Baseline (Day -28 to Day -1), Month 12 |
| Number of Participants With Suicidal Ideation and Suicidal Behavior as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) | eC-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation was defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent. | Baseline (Day -28 to Day -1), Month 12 |
| Baseline (Day -28 to Day -1), Month 12 |
| Change From Baseline in Monthly Average Number of Headache Days of Any Severity During the 4-Week Period at Month 12 | Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of any severity for both CM and EM participants was defined as a calendar day (00:00 to 23:59) where the participant (using the electronic headache diary device) reports: a day with headache pain that lasts at least 4 hours with a peak severity of any severity or; a day when the participant used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) * 28. The change was calculated as post-baseline value - baseline value. | Baseline (Day -28 to Day -1), Month 12 |
| Percentage of Participants With At Least 50% Reduction From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period at Month 12 | A migraine day was defined as when at least 1 of the following situations occurred: A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for migraine with or without aura; a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in e-diary over relevant period) * 28. | Baseline (Day -28 to Day -1), Month 12 |
| Percentage of Participants With At Least 50% Reduction From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During the 4-Week Period | Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of at least moderate severity for both CM and EM participants was defined as a calendar day (00:00 to 23:59) where the participant (using the electronic headache diary device) reports: a day with headache pain that lasts at least 4 hours with a peak severity of at least moderate severity or; a day when the participant used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) * 28. | Baseline (Day -28 to Day -1), Month 12 |
| Birmingham |
| Alabama |
| 35216 |
| United States |
| Teva Investigational Site 13606 | Phoenix | Arizona | 85018 | United States |
| Teva Investigational Site 13579 | Phoenix | Arizona | 85023 | United States |
| Teva Investigational Site 13602 | Little Rock | Arkansas | 72205 | United States |
| Teva Investigational Site 13568 | Encino | California | 91316 | United States |
| Teva Investigational Site 13546 | Fullerton | California | 92835 | United States |
| Teva Investigational Site 13540 | Long Beach | California | 90806 | United States |
| Teva Investigational Site 13632 | Redlands | California | 92374 | United States |
| Teva Investigational Site 13571 | Redondo Beach | California | 90277 | United States |
| Teva Investigational Site 13573 | San Diego | California | 92103 | United States |
| Teva Investigational Site 13538 | Santa Monica | California | 90404 | United States |
| Teva Investigational Site 13594 | Santa Rosa | California | 95405 | United States |
| Teva Investigational Site 13595 | Walnut Creek | California | 94598 | United States |
| Teva Investigational Site 13629 | Aurora | Colorado | 80014 | United States |
| Teva Investigational Site 13557 | Boulder | Colorado | 80301 | United States |
| Teva Investigational Site 13593 | Colorado Springs | Colorado | 80918 | United States |
| Teva Investigational Site 13633 | Denver | Colorado | 80210 | United States |
| Teva Investigational Site 13612 | Denver | Colorado | 80239 | United States |
| Teva Investigational Site 13631 | Englewood | Colorado | 80113 | United States |
| Teva Investigational Site 13563 | East Hartford | Connecticut | 06118 | United States |
| Teva Investigational Site 13550 | Stamford | Connecticut | 06905 | United States |
| Teva Investigational Site 13635 | Bradenton | Florida | 34201 | United States |
| Teva Investigational Site 13597 | Gainesville | Florida | 32607 | United States |
| Teva Investigational Site 13607 | Hialeah | Florida | 33012 | United States |
| Teva Investigational Site 13559 | Jacksonville | Florida | 32205 | United States |
| Teva Investigational Site 13584 | Ocala | Florida | 34471 | United States |
| Teva Investigational Site 13587 | Orlando | Florida | 32806 | United States |
| Teva Investigational Site 13567 | Palm Beach Gardens | Florida | 33410 | United States |
| Teva Investigational Site 13553 | Pembroke Pines | Florida | 33026 | United States |
| Teva Investigational Site 13616 | Pinellas Park | Florida | 33781 | United States |
| Teva Investigational Site 13620 | Atlanta | Georgia | 30312 | United States |
| Teva Investigational Site 13537 | Atlanta | Georgia | 30342 | United States |
| Teva Investigational Site 13604 | Boise | Idaho | 83642 | United States |
| Teva Investigational Site 13585 | Chicago | Illinois | 60607 | United States |
| Teva Investigational Site 13621 | Chicago | Illinois | 60654 | United States |
| Teva Investigational Site 13627 | Evanston | Illinois | 60201 | United States |
| Teva Investigational Site 13596 | Indianapolis | Indiana | 46254 | United States |
| Teva Investigational Site 13617 | Wichita | Kansas | 67207 | United States |
| Teva Investigational Site 13598 | Wichita | Kansas | 67211 | United States |
| Teva Investigational Site 13566 | Louisville | Kentucky | 40207 | United States |
| Teva Investigational Site 13603 | Metairie | Louisiana | 70006 | United States |
| Teva Investigational Site 13582 | Pikesville | Maryland | 21208 | United States |
| Teva Investigational Site 13590 | Boston | Massachusetts | 02131 | United States |
| Teva Investigational Site 13589 | New Bedford | Massachusetts | 02301 | United States |
| Teva Investigational Site 13543 | Watertown | Massachusetts | 02472 | United States |
| Teva Investigational Site 13539 | Ann Arbor | Michigan | 48104 | United States |
| Teva Investigational Site 13542 | Golden Valley | Minnesota | 55422 | United States |
| Teva Investigational Site 13534 | Kansas City | Missouri | 64114 | United States |
| Teva Investigational Site 13536 | Springfield | Missouri | 65807 | United States |
| Teva Investigational Site 13619 | St Louis | Missouri | 63141 | United States |
| Teva Investigational Site 13618 | Fremont | Nebraska | 68025 | United States |
| Teva Investigational Site 13605 | Las Vegas | Nevada | 89106 | United States |
| Teva Investigational Site 13578 | Lebanon | New Hampshire | 03756 | United States |
| Teva Investigational Site 13575 | Martinsville | New Jersey | 08836 | United States |
| Teva Investigational Site 13622 | Princeton | New Jersey | 08540 | United States |
| Teva Investigational Site 13588 | Albuquerque | New Mexico | 87102 | United States |
| Teva Investigational Site 13576 | Amherst | New York | 14226 | United States |
| Teva Investigational Site 13565 | Plainview | New York | 11803 | United States |
| Teva Investigational Site 13544 | Greensboro | North Carolina | 27405 | United States |
| Teva Investigational Site 13574 | Greensboro | North Carolina | 27408 | United States |
| Teva Investigational Site 13545 | Raleigh | North Carolina | 27612 | United States |
| Teva Investigational Site 13609 | Akron | Ohio | 44311 | United States |
| Teva Investigational Site 13625 | Akron | Ohio | 44311 | United States |
| Teva Investigational Site 13634 | Akron | Ohio | 44311 | United States |
| Teva Investigational Site 13533 | Cincinnati | Ohio | 45227 | United States |
| Teva Investigational Site 13624 | Cincinnati | Ohio | 45249 | United States |
| Teva Investigational Site 13569 | Cleveland | Ohio | 44195 | United States |
| Teva Investigational Site 13626 | Columbus | Ohio | 43212 | United States |
| Teva Investigational Site 13561 | Oklahoma City | Oklahoma | 73112 | United States |
| Teva Investigational Site 13601 | Eugene | Oregon | 97401 | United States |
| Teva Investigational Site 13591 | Jenkintown | Pennsylvania | 19046 | United States |
| Teva Investigational Site 13554 | Philadelphia | Pennsylvania | 19107 | United States |
| Teva Investigational Site 13608 | Uniontown | Pennsylvania | 15401 | United States |
| Teva Investigational Site 13615 | Greer | South Carolina | 29650 | United States |
| Teva Investigational Site 13556 | Mt. Pleasant | South Carolina | 29464 | United States |
| Teva Investigational Site 13560 | Bristol | Tennessee | 37620 | United States |
| Teva Investigational Site 13551 | Memphis | Tennessee | 38119 | United States |
| Teva Investigational Site 13532 | Nashville | Tennessee | 37203 | United States |
| Teva Investigational Site 13552 | Nashville | Tennessee | 37203 | United States |
| Teva Investigational Site 13541 | Austin | Texas | 78731 | United States |
| Teva Investigational Site 13623 | Dallas | Texas | 75214 | United States |
| Teva Investigational Site 13611 | Plano | Texas | 75024 | United States |
| Teva Investigational Site 13572 | San Antonio | Texas | 78229 | United States |
| Teva Investigational Site 13614 | Murray | Utah | 84107 | United States |
| Teva Investigational Site 13581 | West Jordan | Utah | 84088 | United States |
| Teva Investigational Site 13630 | Virginia Beach | Virginia | 23454 | United States |
| Teva Investigational Site 13564 | Seattle | Washington | 98105 | United States |
| Teva Investigational Site 13586 | Seattle | Washington | 98105 | United States |
| Teva Investigational Site 13600 | Morgantown | West Virginia | 26506 | United States |
| Teva Investigational Site 11124 | Hamilton | Ontario | L8N 1Y2 | Canada |
| Teva Investigational Site 11122 | Newmarket | Ontario | L3Y5G8 | Canada |
| Teva Investigational Site 11120 | Calgary | T3M 1M4 | Canada |
| Teva Investigational Site 11121 | Montreal | H2W 1V1 | Canada |
| Teva Investigational Site 11123 | Sarnia | N7T 4X3 | Canada |
| Teva Investigational Site 54144 | Brno | 602 00 | Czechia |
| Teva Investigational Site 54141 | Kunratice | 14800 | Czechia |
| Teva Investigational Site 54145 | Pardubice | 53002 | Czechia |
| Teva Investigational Site 54143 | Prague | 100 00 | Czechia |
| Teva Investigational Site 54146 | Prague | 130 00 | Czechia |
| Teva Investigational Site 54142 | Prague | 140 59 | Czechia |
| Teva Investigational Site 40018 | Helsinki | 00180 | Finland |
| Teva Investigational Site 40017 | Helsinki | 00930 | Finland |
| Teva Investigational Site 40016 | Turku | 20100 | Finland |
| Teva Investigational Site 80096 | Holon | 58100 | Israel |
| Teva Investigational Site 80099 | Jerusalem | 9112001 | Israel |
| Teva Investigational Site 80098 | Nahariya | 221001 | Israel |
| Teva Investigational Site 80097 | Netanya | 4244916 | Israel |
| Teva Investigational Site 80100 | Ramat Gan | 5265601 | Israel |
| Teva Investigational Site 80095 | Tel Aviv | 6423906 | Israel |
| Teva Investigational Site 84072 | Chofu-shi | 182-0006 | Japan |
| Teva Investigational Site 84066 | Kagoshima | 892-0844 | Japan |
| Teva Investigational Site 84069 | Kai | 400-0124 | Japan |
| Teva Investigational Site 84073 | Kawasaki | 211-8588 | Japan |
| Teva Investigational Site 84067 | Kyoto | 600-8811 | Japan |
| Teva Investigational Site 84062 | Osaka | 556-0015 | Japan |
| Teva Investigational Site 84070 | Saitama | 338-8577 | Japan |
| Teva Investigational Site 84061 | Sendai | 982-0014 | Japan |
| Teva Investigational Site 84063 | Shinjuku-ku | 160-8582 | Japan |
| Teva Investigational Site 84068 | Shizuoka | 4200-853 | Japan |
| Teva Investigational Site 84065 | Tochigi | 321-0293 | Japan |
| Teva Investigational Site 84064 | Tokyo | 182-0006 | Japan |
| Teva Investigational Site 84071 | Toyonaka | Japan |
| Teva Investigational Site 53364 | Krakow | 31-523 | Poland |
| Teva Investigational Site 53363 | Krakow | 33-332 | Poland |
| Teva Investigational Site 53366 | Lublin | 20-022 | Poland |
| Teva Investigational Site 53365 | Poznan | 60-529 | Poland |
| Teva Investigational Site 53367 | Warsaw | 04-730 | Poland |
| Teva Investigational Site 50399 | Kazan' | 420012 | Russia |
| Teva Investigational Site 50395 | Kazan' | 420021 | Russia |
| Teva Investigational Site 50394 | Moscow | 121467 | Russia |
| Teva Investigational Site 50400 | Moscow | 129128 | Russia |
| Teva Investigational Site 50398 | Nizhny Novgorod | 603126 | Russia |
| Teva Investigational Site 50396 | Nizhny Novgorod | 603137 | Russia |
| Teva Investigational Site 50397 | Ufa | 450007 | Russia |
| Teva Investigational Site 31207 | Madrid | 28046 | Spain |
| Teva Investigational Site 31208 | Pamplona | 31008 | Spain |
| Teva Investigational Site 31205 | Valladolid | 47003 | Spain |
| Teva Investigational Site 31206 | Zaragoza | 50009 | Spain |
| FG001 | TEV-48125 225 mg Monthly: Active Rollover Participants | Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
| FG002 | TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants | Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
| FG003 | TEV-48125 675 mg Quarterly: Active Rollover Participants | Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
| Safety Analysis Set | Received at least 1 dose of study drug |
|
| Full Analysis Set (FAS) | Participants in safety analysis set who had at least 10 days of post-baseline efficacy assessment. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) analysis set included all participants who were randomized in this study for long-term safety evaluation, regardless if they receive study treatment or not.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TEV-48125 225 mg Monthly: New/Placebo Rollover Participants | Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
| BG001 | TEV-48125 225 mg Monthly: Active Rollover Participants | Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
| BG002 | TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants | Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
| BG003 | TEV-48125 675 mg Quarterly: Active Rollover Participants | Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Number of Migraine Days | A migraine day was defined as when at least 1 of the following situations occurred: A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for migraine with or without aura; a calendar day demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for probable migraine; a calendar day demonstrating a headache of any duration that was treated with migraine-specific medications. | Mean | Standard Deviation | days |
| ||||||||||||||
| Number of Headache Days of Any Severity | Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of any severity for both CM and EM participants was defined as a calendar day (00:00 to 23:59) where the participant (using the electronic headache diary device) reports: a day with headache pain that lasts at least 4 hours with a peak severity of any severity or; a day when the participant used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. | Mean | Standard Deviation | days |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE was defined as inability to carry out usual activities. Treatment-related AEs were defined as AEs with possible, probable, definite, or missing relationship to study drug. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Safety population included all participants who received at least 1 dose of fremanezumab. | Posted | Count of Participants | Participants | Baseline (Day 0) up to follow-up visit (Day 533) |
|
|
| |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period at Month 12 | A migraine day was defined as when at least 1 of the following situations occurred: A calendar day(0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for migraine with or without aura; a calendar day(0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was missing; a calendar day(0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in e-diary over relevant period)*28. Change was calculated as post-baseline value - baseline value. | Full analysis set (FAS):all participants who received at least 1 dose of fremanezumab, had at least 10 days of efficacy assessments by e-diary after first injection for this study. Data for this outcome was collected and reported separately for CM and EM participants.'Overall number of participants analyzed'=participants evaluable for this outcome. | Posted | Mean | Standard Deviation | days/month | Baseline (Day -28 to Day -1), Month 12 |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Monthly Average Number of Headache Days of Any Severity During the 4-Week Period at Month 12 | Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of any severity for both CM and EM participants was defined as a calendar day (00:00 to 23:59) where the participant (using the electronic headache diary device) reports: a day with headache pain that lasts at least 4 hours with a peak severity of any severity or; a day when the participant used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) * 28. The change was calculated as post-baseline value - baseline value. | FAS: all participants who received at least 1 dose of fremanezumab, and had at least 10 days of efficacy assessments by electronic diary after first injection for this study. Data for this outcome was collected and reported separately for CM and EM participants. 'Overall number of participants analyzed' = participants evaluable for this outcome. | Posted | Mean | Standard Deviation | days/month | Baseline (Day -28 to Day -1), Month 12 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results | Potentially clinically significant abnormal serum chemistry findings included: Blood Urea Nitrogen (BUN): greater than or equal to (>=) 10.71 millimoles/liter (mmol/L), creatinine: >=177 micromoles/liter (µmol/L), bilirubin: >=34.2 µmol/L, Alanine Aminotransferase (ALT) (units/liter [U/L]): >=3*upper limit of normal (ULN) Aspartate Aminotransferase (AST) (U/L): >=3*ULN, and Gamma Glutamyl Transferase (GGT) (U/L): >=3*ULN. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Safety population included all participants who received at least 1 dose of fremanezumab. Here, 'Overall number of participants analyzed'=participants with both baseline and post-baseline serum chemistry values. | Posted | Count of Participants | Participants | Baseline (Day 0) up to end of treatment (EOT) visit (Day 336) |
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| Primary | Number of Participants With Potentially Clinically Significant Abnormal Hematology Results | Potentially clinically significant abnormal hematology findings included: hemoglobin: less than (<) 115 grams/liter (g/L) (in males) or less than or equal to (<=) 95 g/L (in females), hematocrit: <0.37 L/L (in male) or <0.32 L/L (in female), leukocytes: >=20*10^9/L or <=3*10^9/L, eosinophils/leukocytes: >=10%, and platelets: >=700*10^9/L or <=75*10^9/L. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Safety population included all participants who received at least 1 dose of fremanezumab. Here, 'Overall number of participants analyzed'=participants with both baseline and post-baseline hematology parameter values. | Posted | Count of Participants | Participants | Baseline (Day 0) up to EOT visit (Day 336) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Potentially Clinically Significant Abnormal Urinalysis Laboratory Tests Results | Potentially clinically significant abnormal urinalysis findings included: blood: >=2 unit increase from baseline, urine glucose (milligrams/decilitre [mg/dL]): >=2 unit increase from baseline, ketones (mg/dL): >=2 unit increase from baseline, urine protein (mg/dL): >=2 unit increase from baseline. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Safety population included all participants who received at least 1 dose of fremanezumab. Here, 'Overall number of participants analyzed'=participants with both baseline and post-baseline urinalysis values. | Posted | Count of Participants | Participants | Baseline (Day 0) up to EOT visit (Day 336) |
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| Primary | Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values | Potentially clinically significant abnormal vital signs findings included: pulse rate: <=50 beats/minute (bpm) and decrease of >=15 bpm, or >=120 bpm and increase of >=15 bpm; systolic blood pressure: <=90 millimeters of mercury (mmHg) and decrease of >=20 mmHg, or >=180 mmHg and increase of >=20 mmHg; diastolic blood pressure: <=50 mmHg and decrease of >=15 mmHg or >=105 mmHg and increase of >=15 mmHg; respiratory rate: <10 breaths/minute; and body temperature >=38.3 degrees centigrade and change of >=1.1 degrees centigrade. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Safety population included all participants who received at least 1 dose of fremanezumab. Here, 'Overall number of participants analyzed'=participants with both baseline and post-baseline vital signs values. | Posted | Count of Participants | Participants | Baseline (Day 0) up to EOT visit (Day 336) |
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| Primary | Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters | ECG parameters included: heart rate, PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF), QT interval corrected using the Bazett's formula (QTcB) and RR interval. Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Safety population included all participants who received at least 1 dose of fremanezumab. Here, 'Overall number of participants analyzed' = participants with both baseline and endpoint electrocardiogram findings. | Posted | Count of Participants | Participants | Baseline (Day 0), endpoint (Day 336) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results | Coagulation parameters included: prothrombin time (PT) (seconds), prothrombin international normalized ratio (INR), activated partial thromboplastin time (aPTT) (seconds). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Shifts from baseline to endpoint were summarized using participant counts grouped into three categories: - Low (below normal range) - Normal (within the normal range of 9.4 to 12.5 seconds) - High (above normal range). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Safety population included all participants who received at least 1 dose of fremanezumab. Here, 'Overall number of participants analyzed' = participants with both baseline and endpoint coagulation laboratory test results. 'Number analyzed' = participants evaluable for specified categories. | Posted | Count of Participants | Participants | Baseline (Day 0), endpoint (Day 336) |
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| Other Pre-specified | Percentage of Participants With At Least 50% Reduction From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period at Month 12 | A migraine day was defined as when at least 1 of the following situations occurred: A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for migraine with or without aura; a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in e-diary over relevant period) * 28. | FAS: all participants who received at least 1 dose of fremanezumab, and had at least 10 days of efficacy assessments by electronic diary after first injection for this study. Data for this outcome was collected and reported separately for CM and EM participants. 'Overall number of participants analyzed' = participants evaluable for this outcome. | Posted | Number | percentage of participants | Baseline (Day -28 to Day -1), Month 12 |
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| Other Pre-specified | Percentage of Participants With At Least 50% Reduction From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During the 4-Week Period | Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of at least moderate severity for both CM and EM participants was defined as a calendar day (00:00 to 23:59) where the participant (using the electronic headache diary device) reports: a day with headache pain that lasts at least 4 hours with a peak severity of at least moderate severity or; a day when the participant used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) * 28. | FAS: all participants who received at least 1 dose of fremanezumab, and had at least 10 days of efficacy assessments by electronic diary after first injection for this study. Data for this outcome was collected and reported separately for CM and EM participants. 'Overall number of participants analyzed' = participants evaluable for this outcome. | Posted | Number | percentage of participants | Baseline (Day -28 to Day -1), Month 12 |
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| Primary | Number of Participants With Injection Site Reactions | Number of participants who reported treatment-emergent injection site reactions are summarized. Preferred terms from MedDRA version 18.1 were offered without a threshold applied. Injection site reactions included injection site induration, pain, erythema, haemorrhage, pruritus, swelling, bruising, rash, urticaria, warmth, dermatitis, haematoma, inflammation, discolouration, discomfort, hypersensitivity, hypoaesthesia, irritation, oedema, papule, paraesthesia, vesicles and pallor. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. | Safety population included all participants who received at least 1 dose of fremanezumab. | Posted | Count of Participants | Participants | Baseline (Day -28 to Day -1), Month 12 |
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| Primary | Number of Participants With Suicidal Ideation and Suicidal Behavior as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) | eC-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation was defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent. | Safety population included all participants who received at least 1 dose of fremanezumab. | Posted | Count of Participants | Participants | Baseline (Day -28 to Day -1), Month 12 |
|
Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TEV-48125 225 mg Monthly: New/Placebo Rollover Participants | Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). | 0 | 418 | 27 | 418 | 300 | 418 |
| EG001 | TEV-48125 225 mg Monthly: Active Rollover Participants | Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). | 0 | 526 | 29 | 526 | 367 | 526 |
| EG002 | TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants | Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). | 1 | 419 | 36 | 419 | 284 | 419 |
| EG003 | TEV-48125 675 mg Quarterly: Active Rollover Participants | Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). | 0 | 525 | 23 | 525 | 329 | 525 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Arteriovenous malformation | Congenital, familial and genetic disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cerebrovascular arteriovenous malformation | Congenital, familial and genetic disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Congenital cyst | Congenital, familial and genetic disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Congenital cystic disease of liver | Congenital, familial and genetic disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hereditary haemochromatosis | Congenital, familial and genetic disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Macular degeneration | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Retinal tear | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Barrett's oesophagus | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ileal stenosis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hepatitis alcoholic | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Allergy to arthropod sting | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Petrositis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Ammonia increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vertebral osteophyte | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Breast cancer stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment | This is a gender-specific AE. Only female participants were at risk. |
|
| High grade B-cell lymphoma Burkitt-like lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Phyllodes tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Pituitary tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment | This is a gender-specific AE. Only male participants were at risk. |
|
| Superficial spreading melanoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Central nervous system lesion | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cluster headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Myasthenia gravis | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nerve compression | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Parkinsonism | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Perineurial cyst | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Primary progressive multiple sclerosis | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Status migrainosus | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Transient global amnesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment | This is a gender-specific AE. Only female participants were at risk. |
|
| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment | This is a gender-specific AE. Only female participants were at risk. |
|
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment | This is a gender-specific AE. Only female participants were at risk. |
|
| Premature separation of placenta | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment | This is a gender-specific AE. Only female participants were at risk. |
|
| Adjustment disorder with mixed disturbance of emotion and conduct | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment | This is a gender-specific AE. Only female participants were at risk. |
|
| Haemorrhagic ovarian cyst | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment | This is a gender-specific AE. Only female participants were at risk. |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment | This is a gender-specific AE. Only female participants were at risk. |
|
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment | This is a gender-specific AE. Only female participants were at risk. |
|
| Ovarian mass | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment | This is a gender-specific AE. Only female participants were at risk. |
|
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment | This is a gender-specific AE. Only female participants were at risk. |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lung consolidation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Salpingo-oophorectomy | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Teva Branded Pharmaceutical Products, R&D Inc. | 1-888-483-8279 | USMedInfo@tevapharm.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 13, 2017 | Jun 5, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000604315 | fremanezumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black |
|
| Asian |
|
| American Indian or Alaskan Native |
|
| Native Hawaiian or other Pacific Islander |
|
| Other |
|
| Severe AEs |
|
| Treatment-related AEs |
|
| Serious AEs |
|
| AEs leading to discontinuation from study |
|
| OG001 | TEV-48125 225 mg Monthly: Active Rollover CM Participants | Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
| OG002 | TEV-48125 675mg Quarterly:New/Placebo Rollover CM Participants | Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
| OG003 | TEV-48125 675 mg Quarterly: Active Rollover CM Participants | Participants with CM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
| OG004 | TEV-48125 225 mg Monthly: New/Placebo Rollover EM Participants | Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
| OG005 | TEV-48125 225 mg Monthly: Active Rollover EM Participants | Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
| OG006 | TEV-48125 675mg Quarterly:New/Placebo Rollover EM Participants | Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
| OG007 | TEV-48125 675 mg Quarterly: Active Rollover EM Participants | Participants with EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
|
|
| OG001 | TEV-48125 225 mg Monthly: Active Rollover CM Participants | Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
| OG002 | TEV-48125 675mg Quarterly:New/Placebo Rollover CM Participants | Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
| OG003 | TEV-48125 675 mg Quarterly: Active Rollover CM Participants | Participants with CM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
| OG004 | TEV-48125 225 mg Monthly: New/Placebo Rollover EM Participants | Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
| OG005 | TEV-48125 225 mg Monthly: Active Rollover EM Participants | Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
| OG006 | TEV-48125 675mg Quarterly:New/Placebo Rollover EM Participants | Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
| OG007 | TEV-48125 675 mg Quarterly: Active Rollover EM Participants | Participants with EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
|
|
| OG001 | TEV-48125 225 mg Monthly: Active Rollover Participants | Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
| OG002 | TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants | Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
| OG003 | TEV-48125 675 mg Quarterly: Active Rollover Participants | Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
|
|
| OG001 | TEV-48125 225 mg Monthly: Active Rollover Participants | Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
| OG002 | TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants | Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
| OG003 | TEV-48125 675 mg Quarterly: Active Rollover Participants | Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
|
|
| OG001 | TEV-48125 225 mg Monthly: Active Rollover Participants | Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
| OG002 | TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants | Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
| OG003 | TEV-48125 675 mg Quarterly: Active Rollover Participants | Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
|
|
| OG001 | TEV-48125 225 mg Monthly: Active Rollover Participants | Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
| OG002 | TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants | Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
| OG003 | TEV-48125 675 mg Quarterly: Active Rollover Participants | Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
|
|
| OG001 | TEV-48125 225 mg Monthly: Active Rollover Participants | Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
| OG002 | TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants | Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
| OG003 | TEV-48125 675 mg Quarterly: Active Rollover Participants | Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
|
|
| OG001 | TEV-48125 225 mg Monthly: Active Rollover Participants | Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
| OG002 | TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants | Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
| OG003 | TEV-48125 675 mg Quarterly: Active Rollover Participants | Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
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|
| OG001 | TEV-48125 225 mg Monthly: Active Rollover CM Participants | Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
| OG002 | TEV-48125 675mg Quarterly:New/Placebo Rollover CM Participants | Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
| OG003 | TEV-48125 675 mg Quarterly: Active Rollover CM Participants | Participants with CM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
| OG004 | TEV-48125 225 mg Monthly: New/Placebo Rollover EM Participants | Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
| OG005 | TEV-48125 225 mg Monthly: Active Rollover EM Participants | Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
| OG006 | TEV-48125 675mg Quarterly:New/Placebo Rollover EM Participants | Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
| OG007 | TEV-48125 675 mg Quarterly: Active Rollover EM Participants | Participants with EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
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| OG001 | TEV-48125 225 mg Monthly: Active Rollover CM Participants | Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
| OG002 | TEV-48125 675mg Quarterly:New/Placebo Rollover CM Participants | Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
| OG003 | TEV-48125 675 mg Quarterly: Active Rollover CM Participants | Participants with CM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
| OG004 | TEV-48125 225 mg Monthly: New/Placebo Rollover EM Participants | Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
| OG005 | TEV-48125 225 mg Monthly: Active Rollover EM Participants | Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
| OG006 | TEV-48125 675mg Quarterly:New/Placebo Rollover EM Participants | Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
| OG007 | TEV-48125 675 mg Quarterly: Active Rollover EM Participants | Participants with EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308). |
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| OG001 | TEV-48125 225 mg Monthly: Active Rollover Participants | Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
| OG002 | TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants | Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
| OG003 | TEV-48125 675 mg Quarterly: Active Rollover Participants | Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
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| OG001 | TEV-48125 225 mg Monthly: Active Rollover Participants | Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
| OG002 | TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants | Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
| OG003 | TEV-48125 675 mg Quarterly: Active Rollover Participants | Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). |
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| Low-Normal |
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| Low-High |
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| Normal-Low |
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| Normal-Normal |
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| Normal-High |
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| High-Low |
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| High-Normal |
|
| High-High |
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| Title | Measurements |
|---|---|
| Low-Low |
|
| Low-Normal |
|
| Low-High |
|
| Normal-Low |
|
| Normal-Normal |
|
| Normal-High |
|
| High-Low |
|
| High-Normal |
|
| High-High |
|
| Title | Measurements |
|---|---|
| Low-Low |
|
| Low-Normal |
|
| Low-High |
|
| Normal-Low |
|
| Normal-Normal |
|
| Normal-High |
|
| High-Low |
|
| High-Normal |
|
| High-High |
|