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This study is to evaluate the efficacy and safety of AMG334 in adult patients with episodic migraine
This study used a single-cohort, 3-treatment arm, randomized, double-blind study design in adult patients with episodic migraine. The subjects were randomized to receive either erenumab or placebo in a 2:3:3 ratio (erenumab 140 mg: erenumab 70 mg: placebo). A screening period of 2 weeks was used to assess initial eligibility, followed by a 4-week baseline period. After randomization/Day 1, visits occurred at four week intervals until Week 12, which was the End of Treatment. The final visit, Last Patient Last Visit was a Safety Follow-Up visit, which occurred 12 weeks later, at Week 24.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG334 70 mg | Experimental | AMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days |
|
| AMG334 140 mg | Experimental | AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days |
|
| Placebo | Placebo Comparator | Two pre-filled syringes containing placebo identical in appearance to erenumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erenumab | Biological | 70 mg/mL pre-filled syringe administered subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Monthly Migraine Days at the Last Month (Month 3) of the Double-blind Treatment Period (DBTP) | A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria:
| Baseline up to Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Month 3 | Achievement of at least a 50% reduction from baseline in monthly migraine days at Month 3. A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria:
|
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Key inclusion criteria:
Key exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | CABA | Buenos Aires | C1056ABJ | Argentina | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41641373 | Derived | Wang SJ, Roxas AA, Saravia B, Kim BK, Chowdhury D, Riachi NJ, Tai MS, Tanprawate S, Tran TN, Zhao YJ, Su W, Wen S, Mondal S, Ecochard L, Arkuszewski M. Effect of Erenumab on Patient-Reported Outcomes in Episodic Migraine in Asia, the Middle East, and Latin America: Results From the EMPOwER Study. Neurol Clin Pract. 2026 Apr;16(2):e200565. doi: 10.1212/CPJ.0000000000200565. Epub 2026 Feb 2. | |
| 35978286 |
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
Not provided
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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| ID | Title | Description |
|---|---|---|
| FG000 | AMG334 70 mg | AMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days |
| FG001 | AMG334 140 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-blind Treatment Period (DBTP) |
|
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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 | Jun 7, 2017 | Jan 11, 2021 |
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| Placebo | Other | Matching placebo in pre-filled syringe administered subcutaneously |
|
| Baseline and at Month 3 |
| Change From Baseline in Acute Migraine-specific Medication Treatment Days at Month 3 | Number of days on which acute migraine-specific medications were used were recorded in eDiary between each monthly IP dose. Migraine-Specific medications include two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications. Monthly migraine-specific medication use at baseline is the number of migraine-specific medication treatment days in the baseline period. | Baseline up to Month 3 |
| Change From Baseline in Headache Impact Scores as Measured by the Headache Impact Test (HIT-6) at Month 3 | The HIT-6 is a short-form self-administered questionnaire based on the internet-HIT question pool. The HIT-6 was developed as a global measure of adverse headache impact to assess headache severity in the previous month and change in a patient's clinical status over a short period of time. Six items assess the frequency of pain severity, headaches limiting daily activity (household, work, school, and social). Each of the 6 questions is responded to using 1 of 5 response categories: "never," "rarely," "sometimes," "very often," or "always." For each HIT-6 item, 6, 8, 10, 11, or 13 points, respectively, are assigned to the response provided. These points were summed to produce a total HIT-6 score that ranges from 36 to 78. Scores were categorized into 4 grades, representing little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78) due to headache. Lower values represent better outcomes, therefore negative change denotes improveme | Baseline up to Month 3 |
| CABA |
| Buenos Aires |
| C1181ACH |
| Argentina |
| Novartis Investigative Site | CABA | Buenos Aires | C1428AQK | Argentina |
| Novartis Investigative Site | Buenos Aires | 1061 | Argentina |
| Novartis Investigative Site | Buenos Aires | C1012AAR | Argentina |
| Novartis Investigative Site | Ciudad Autonoma de Bs As | C1128AAF | Argentina |
| Novartis Investigative Site | Córdoba | 5001 | Argentina |
| Novartis Investigative Site | Guntur | Andhra Pradesh | 522 001 | India |
| Novartis Investigative Site | Ahmedabad | Gujarat | 382428 | India |
| Novartis Investigative Site | Bangalore | Karnataka | 560054 | India |
| Novartis Investigative Site | Bangalore | Karnataka | 560060 | India |
| Novartis Investigative Site | Mysore | Karnataka | 570001 | India |
| Novartis Investigative Site | Kochi | Kerala | 682 026 | India |
| Novartis Investigative Site | Kochi | Kerala | 682027 | India |
| Novartis Investigative Site | Kozhikode | Kerala | 673004 | India |
| Novartis Investigative Site | Thiruvananthapuram | Kerala | 695011 | India |
| Novartis Investigative Site | Mumbai | Maharashtra | 400008 | India |
| Novartis Investigative Site | Mumbai | Maharashtra | 401107 | India |
| Novartis Investigative Site | Nagpur | Maharashtra | 400 012 | India |
| Novartis Investigative Site | Nashik | Maharashtra | 422 005 | India |
| Novartis Investigative Site | Nashik | Maharashtra | 422005 | India |
| Novartis Investigative Site | Pune | Maharashtra | 411004 | India |
| Novartis Investigative Site | New Delhi | National Capital Territory of Delhi | 110 060 | India |
| Novartis Investigative Site | New Delhi | National Capital Territory of Delhi | 110002 | India |
| Novartis Investigative Site | Ludhiana | Punjab | 141001 | India |
| Novartis Investigative Site | Chennai | Tamil Nadu | 600100 | India |
| Novartis Investigative Site | Hyderabad | Telangana | 500082 | India |
| Novartis Investigative Site | Lucknow | Uttar Pradesh | 226014 | India |
| Novartis Investigative Site | Dehradun | Uttarakhand | 248001 | India |
| Novartis Investigative Site | Kolkata | West Bengal | 700017 | India |
| Novartis Investigative Site | Kolkata | West Bengal | 700068 | India |
| Novartis Investigative Site | Belagavi | 590010 | India |
| Novartis Investigative Site | Mumbai | 400016 | India |
| Novartis Investigative Site | New Delhi | 110029 | India |
| Novartis Investigative Site | El Chouf | LBN | 1503201002 | Lebanon |
| Novartis Investigative Site | Beirut | 1107 2020 | Lebanon |
| Novartis Investigative Site | Beirut | 166378 | Lebanon |
| Novartis Investigative Site | Beirut | 6301 | Lebanon |
| Novartis Investigative Site | Beirut | Lebanon |
| Novartis Investigative Site | Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
| Novartis Investigative Site | Kuala Lumpur | MYS | 56000 | Malaysia |
| Novartis Investigative Site | Seberang Jaya | Pulau Pinang | 13700 | Malaysia |
| Novartis Investigative Site | Sungai Buloh | Selangor | 47000 | Malaysia |
| Novartis Investigative Site | Kuala Lumpur | 59100 | Malaysia |
| Novartis Investigative Site | Guadalajara | Jalisco | 44130 | Mexico |
| Novartis Investigative Site | Guadalajara | Jalisco | 44610 | Mexico |
| Novartis Investigative Site | Monterrey | Nuevo León | 64060 | Mexico |
| Novartis Investigative Site | Chihuahua City | 31203 | Mexico |
| Novartis Investigative Site | Manila | National Capital Region | 1000 | Philippines |
| Novartis Investigative Site | Manila | National Capital Region | 1012 | Philippines |
| Novartis Investigative Site | Pasig | 1605 | Philippines |
| Novartis Investigative Site | Quezon City | 1102 | Philippines |
| Novartis Investigative Site | Singapore | 169608 | Singapore |
| Novartis Investigative Site | Singapore | 308433 | Singapore |
| Novartis Investigative Site | Hwaseong-si | Gyeonggi-do | 18450 | South Korea |
| Novartis Investigative Site | Daejeon | Korea | 35015 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 03080 | South Korea |
| Novartis Investigative Site | Seoul | KOR | 03181 | South Korea |
| Novartis Investigative Site | Seoul | KOR | 08308 | South Korea |
| Novartis Investigative Site | Busan | 47392 | South Korea |
| Novartis Investigative Site | Gwangju | 61469 | South Korea |
| Novartis Investigative Site | Gyeonggi-do | 11765 | South Korea |
| Novartis Investigative Site | Incheon | 22332 | South Korea |
| Novartis Investigative Site | Seoul | 03722 | South Korea |
| Novartis Investigative Site | Seoul | 06351 | South Korea |
| Novartis Investigative Site | Seoul | 139-711 | South Korea |
| Novartis Investigative Site | Chiayi City | 60002 | Taiwan |
| Novartis Investigative Site | Taichung | 40447 | Taiwan |
| Novartis Investigative Site | Taichung County | Taiwan |
| Novartis Investigative Site | Tainan | 71004 | Taiwan |
| Novartis Investigative Site | Tainan | Taiwan |
| Novartis Investigative Site | Taipei | 10449 | Taiwan |
| Novartis Investigative Site | Taipei | 11217 | Taiwan |
| Novartis Investigative Site | Taoyuan | 33305 | Taiwan |
| Novartis Investigative Site | Bangkok | THA | 10400 | Thailand |
| Novartis Investigative Site | Khon Kaen | THA | 40002 | Thailand |
| Novartis Investigative Site | Bangkok | 10330 | Thailand |
| Novartis Investigative Site | Bangkok | 10400 | Thailand |
| Novartis Investigative Site | Chiang Mai | 50200 | Thailand |
| Novartis Investigative Site | Ho Chi Minh City | VNM | 700000 | Vietnam |
| Novartis Investigative Site | Hanoi | 100000 | Vietnam |
| Derived |
| Lampl C, Kraus V, Lehner K, Loop B, Chehrenama M, Maczynska Z, Ritter S, Klatt J, Snellman J. Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials. J Headache Pain. 2022 Aug 18;23(1):104. doi: 10.1186/s10194-022-01470-4. |
| 34171973 | Derived | Wang SJ, Roxas AA Jr, Saravia B, Kim BK, Chowdhury D, Riachi N, Tai MS, Tanprawate S, Ngoc TT, Zhao YJ, Mikol DD, Pandhi S, Wen S, Mondal S, Tenenbaum N, Hours-Zesiger P. Randomised, controlled trial of erenumab for the prevention of episodic migraine in patients from Asia, the Middle East, and Latin America: The EMPOwER study. Cephalalgia. 2021 Nov;41(13):1285-1297. doi: 10.1177/03331024211024160. Epub 2021 Jun 25. |
AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days
| FG002 | Placebo | Two pre-filled syringes containing placebo identical in appearance to erenumab |
| Full Analysis Set | All participants who started the study medication and completed at least one post-baseline efficacy measurement |
|
| Safety Analysis Set | Safety analysis set consisted of all randomized subjects who received at least one dose of investigational product and were analyzed based on the actual treatment received |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Safety Follow-up Period |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AMG334 70 mg | AMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days |
| BG001 | AMG334 140 mg | AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days |
| BG002 | Placebo | Two pre-filled syringes containing placebo identical in appearance to erenumab |
| BG003 | 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 |
| |||||||||||
| Race/Ethnicity, Customized | If multiple races were reported for a participant, the participant was categorized as multiple and in each selected race category | Number | participants |
| ||||||||||
| Monthly Migraine Days at Baseline | A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria:
| This analysis is based on the data available for computing the monthly migraine days, according to pre-specified algorithm | Mean | Standard Deviation | Migraine days/month |
|
| 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 | Change From Baseline in Monthly Migraine Days at the Last Month (Month 3) of the Double-blind Treatment Period (DBTP) | A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria:
| Full analysis set | Posted | Mean | Standard Error | Migraine days/month | Baseline up to Month 3 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Month 3 | Achievement of at least a 50% reduction from baseline in monthly migraine days at Month 3. A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria:
| Full analysis set | Posted | Number | percentage of participants | Baseline and at Month 3 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Acute Migraine-specific Medication Treatment Days at Month 3 | Number of days on which acute migraine-specific medications were used were recorded in eDiary between each monthly IP dose. Migraine-Specific medications include two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications. Monthly migraine-specific medication use at baseline is the number of migraine-specific medication treatment days in the baseline period. | Analysis set included participants with at least one acute migraine-specific medication use during baseline | Posted | Mean | Standard Error | Migraine days/month | Baseline up to Month 3 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Headache Impact Scores as Measured by the Headache Impact Test (HIT-6) at Month 3 | The HIT-6 is a short-form self-administered questionnaire based on the internet-HIT question pool. The HIT-6 was developed as a global measure of adverse headache impact to assess headache severity in the previous month and change in a patient's clinical status over a short period of time. Six items assess the frequency of pain severity, headaches limiting daily activity (household, work, school, and social). Each of the 6 questions is responded to using 1 of 5 response categories: "never," "rarely," "sometimes," "very often," or "always." For each HIT-6 item, 6, 8, 10, 11, or 13 points, respectively, are assigned to the response provided. These points were summed to produce a total HIT-6 score that ranges from 36 to 78. Scores were categorized into 4 grades, representing little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78) due to headache. Lower values represent better outcomes, therefore negative change denotes improveme | Analysis included participants with a non-missing value at the corresponding time point of interest | Posted | Mean | Standard Error | scores on a scale | Baseline up to Month 3 |
|
Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks
Not provided
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 | AMG 334 70mg | AMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days | 0 | 335 | 10 | 335 | 83 | 335 |
| EG001 | AMG 334 140mg | AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days | 0 | 224 | 0 | 224 | 58 | 224 |
| EG002 | Placebo | Two pre-filled syringes containing placebo identical in appearance to erenumab | 0 | 335 | 5 | 335 | 85 | 335 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cellulitis orbital | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA (22.0) | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (22.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | Novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 27, 2020 | Jan 11, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006261 | Headache |
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |
|---|---|
| C000605816 | erenumab |
Not provided
Not provided
Not provided
|
|
|
| Black or African American |
|
|
| Asian |
|
|
| American Indian or Alaska Native |
|
|
| Multiple |
|
|
| Other |
|
|
|
| <0.001 |
| Median Difference (Final Values) |
| -1.69 |
| Standard Error of the Mean |
| 0.39 |
| 2-Sided |
| 95 |
| -2.45 |
| -0.93 |
| Superiority |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days
| OG002 | Placebo | Two pre-filled syringes containing placebo identical in appearance to erenumab |
|
|
|