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The purpose of this is study is to compare the efficacy of BHV-3000 (rimegepant) to placebo as a preventive treatment for migraine, as measured by the reduction in the number of migraine days per month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBT Rimegepant/OL Rimegepant | Experimental | DBT Phase (Weeks 1 through 12): Participants received a single oral dose of rimegepant 75 mg tablet every other day (EOD) for 12 weeks. OLE Phase (Weeks 13 through 64): Participants who continued to meet study entry criteria and had acceptable laboratory test results per protocol, entered the OLE phase and received a single oral dose of rimegepant 75 mg tablet EOD for 52 weeks. If participants had a migraine on a day that they were not scheduled to dose with rimegepant, they could take one tablet of rimegepant 75 mg on that calendar day to treat a migraine (as needed [PRN] dosing). After completing the OLE phase, participants had follow-up safety visits 2 and 8 weeks after the End-of-Treatment (EOT) visit. Participants who did not complete the DBT phase and/or did not enter or complete the OLE phase were to complete the EOT visit, the 2-week follow-up safety visit, and the 8-week follow-up safety visit after their early discontinuation. |
|
| DBT Placebo/OL Rimegepant | Placebo Comparator | DBT Phase (Weeks 1 through 12): Participants received a single oral dose of placebo matching to rimegepant tablet EOD for 12 weeks. OLE Phase (Weeks 13 through 64): Participants who continued to meet study entry criteria and had acceptable laboratory test results per protocol, entered the OLE phase and received a single oral dose of rimegepant 75 mg tablet EOD for 52 weeks. If participants had a migraine on a day that they were not scheduled to dose with rimegepant, they could take one tablet of rimegepant 75 mg on that calendar day to treat a migraine (PRN dosing). After completing the OLE phase, participants had follow-up safety visits 2 and 8 weeks after the End-of-Treatment (EOT) visit. Participants who did not complete the DBT phase and/or did not enter or complete the OLE phase were to complete the EOT visit, the 2-week follow-up safety visit, and the 8-week follow-up safety visit after their early discontinuation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rimegepant | Drug | Rimegepant 75 mg tablet EOD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Mean Number of Total Migraine Days Per Month in the Last 4 Weeks of the DBT Phase | A migraine day: any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache: a migraine with or without aura, lasting for ≥30 minutes, and meeting at least 1 of the following criteria (a and/or b): a) ≥2 of the following: unilateral location, pulsating quality, moderate to severe pain intensity, aggravation by or causing avoidance of routine physical activity; b) ≥1 of the following: nausea and/or vomiting, photophobia, and phonophobia. If the participant took a migraine-specific medication during aura or to treat headache on a calendar day, it was counted as a migraine day regardless of the duration and pain features/associated symptoms. Months were defined as 28-day intervals. The change from baseline was calculated as the number of monthly migraine days during the last 4 weeks of the DBT phase (Weeks 9 to 12) minus number of monthly migraine days during the OP. | OP and Weeks 9 to 12 of the DBT phase |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had ≥ 50% Reduction in Moderate or Severe Migraine Days Per Month in the Last 4 Weeks of the DBT Phase | A migraine day was any calendar day in which the participant experienced a qualified migraine headache (as previously described). If the participant took a migraine-specific medication during aura or to treat headache on a calendar day, it was counted as a migraine day regardless of the duration and pain features/associated symptoms. A moderate or severe migraine day was a migraine day of moderate or severe pain intensity. Months were defined as 28-day intervals. A reduction of at least 50% in the mean number of moderate or severe monthly migraine days was determined if the number of moderate or severe monthly migraine days in the last 4 weeks of the DBT (Weeks 9 to 12) was less than or equal to half (50%) of the number of moderate or severe monthly migraine days in the OP. |
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Inclusion Criteria:
Subject has at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:
Exclusion Criteria:
Subject with a history of HIV disease
Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening
Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to screening).
Subjects with major depressive episode within the last 12 months, major depressive disorder or any anxiety disorder requiring more than 1 medication for each disorder. Medications to treat major depressive disorder or an anxiety disorder must have been at a stable dose for at least 3 months prior to the Screening visit.
Subjects with other pain syndromes, psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments
Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease that causes malabsorption
Body mass index ≥ 33 kg/m2
Subject has current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder
History of gallstones or cholecystectomy.
The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MDFirst Research-Chandler | Chandler | Arizona | 85286 | United States | ||
| MedPharmics, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40583813 | Derived | Kudrow D, Croop RS, Thiry A, Lipton RB. A 52-week open-label extension study to evaluate the safety and efficacy of oral rimegepant for the preventive treatment of migraine. Headache. 2026 Feb;66(2):407-416. doi: 10.1111/head.15002. Epub 2025 Jun 30. | |
| 38174577 | Derived | Mahon R, Tiwari S, Koch M, Ferraris M, Betts KA, Wang Y, Gao S, Proot P. Comparative effectiveness of erenumab versus rimegepant for migraine prevention using matching-adjusted indirect comparison. J Comp Eff Res. 2024 Mar;13(3):e230122. doi: 10.57264/cer-2023-0122. Epub 2024 Jan 4. |
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A total of 1590 participants were enrolled in the study, of which 747 participants were randomized and 844 were not randomized. Of 747 randomized participants, 741 participants received treatment with blinded study medication. The study was divided into 4 phases: a 4-week observation period (OP), a 12-week double-blind treatment (DBT) phase, a 52-week open-label extension (OLE) phase, and an 8-week follow-up safety phase.
The study was conducted at 92 sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | DBT Rimegepant/OL Rimegepant | DBT phase (Weeks 1 through 12): Participants received a single oral dose of rimegepant 75 mg tablet every other day (EOD) for 12 weeks. OLE phase (Weeks 13 through 64): Participants who continued to meet study entry criteria and had acceptable laboratory test results per protocol, entered the OLE phase and received a single oral dose of rimegepant 75 mg tablet EOD for 52 weeks. If participants had a migraine on a day that they were not scheduled to dose with rimegepant, they could take one tablet of rimegepant 75 mg on that calendar day to treat a migraine (as needed [PRN] dosing). After completing the OLE phase, participants had follow-up safety visits 2 and 8 weeks after the End-of-Treatment (EOT) visit. Participants who did not complete the DBT phase and/or did not enter or complete the OLE phase were to complete the EOT visit, the 2-week follow-up safety visit, and the 8-week follow-up safety visit after their early discontinuation. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| DBT Phase (Weeks 1 to 12) |
|
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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 | Aug 25, 2020 | May 17, 2021 |
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| Placebo | Drug | Placebo tablet to match rimegepant tablet EOD |
|
| OP and Weeks 9 to 12 of the DBT phase |
| Change From Baseline in the Mean Number of Migraine Days Per Month Over the Entire Course of the DBT Phase | A migraine day was any calendar day in which the participant experienced a qualified migraine headache (as previously described). If the participant took a migraine-specific medication during aura or to treat headache on a calendar day, it was counted as a migraine day regardless of the duration and pain features/associated symptoms. Months were defined as 28-day intervals. The change from baseline was calculated as the number of monthly migraine days during the DBT phase (Weeks 1 to 12) minus the number of monthly migraine days during the OP. | OP and Weeks 1 to 12 of the DBT phase |
| Frequency of Use of Rescue Medication Days Per Month in the Last Month of the DBT Phase | A rescue medication day was a day on which the participant took triptan, ergotamine, or other permitted medication to acutely treat headache or aura. Months were defined as 28-day intervals. | Weeks 9 to 12 of the DBT phase |
| Change From Baseline in the Mean Number of Total Migraine Days Per Month in the First Month of the DBT Phase | A migraine day was any calendar day in which the participant experienced a qualified migraine headache (as previously described). If the participant took a migraine-specific medication during aura or to treat headache on a calendar day, it was counted as a migraine day regardless of the duration and pain features/associated symptoms. Months were defined as 28-day intervals. The change from baseline was calculated as the number of monthly migraine days during the first 4 weeks of the DBT phase (Weeks 1 to 4) minus the number of monthly migraine days during the OP. | OP and Weeks 1 to 4 of the DBT phase |
| Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation in the DBT Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition on-treatment in a patient or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. An SAE was defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received rimegepant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention. | Weeks 1 to 12 of the DBT phase |
| Number of Participants With AEs, SAEs, AEs Leading to Study Drug Discontinuation in the OLE Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition on-treatment in a patient or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. An SAE was defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received rimegepant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention. | OLE Phase (Weeks 13 through 64) |
| Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase | Clinically significant laboratory abnormalities were defined as Grade 3 to 4 laboratory test results according to numeric laboratory test criteria found in Common Technical Criteria for Adverse Events (CTCAE) Version 5.0 (2017) if available; otherwise, according to Division of Acquired Immune Deficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017) for glucose, LDL-cholesterol, uric acid, and urinalysis. Laboratory test groups of clinical interest included hematology, serum chemistry, and urinalysis. Participants must have had a non-missing measurement in the DBT phase to be included for a given parameter. | Weeks 1 to 12 of the DBT phase |
| Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase | Clinically significant laboratory abnormalities were defined as Grade 3 to 4 laboratory test results according to numeric laboratory test criteria found in CTCAE Version 5.0 (2017) if available; otherwise, according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017) for glucose, LDL-cholesterol, uric acid, and urinalysis. Laboratory test groups of clinical interest included hematology, serum chemistry, and urinalysis. Participants must have had a non-missing measurement in the OLE phase to be included for a given parameter. | OLE Phase (Weeks 13 through 64) |
| Number of Participants With Elevations of AST or ALT > 3 x Upper Limit of Normal (ULN) Concurrent With Total Bilirubin (TBL) > 2 x ULN During the DBT Phase | Elevations of AST or ALT > 3 x ULN concurrent with TBL > 2 x ULN were defined as elevations on the same collection date. Participants must have had a non-missing AST, ALT, or TBL measurement in the OLE phase to be included. | Weeks 1 to 12 of the DBT phase |
| Percentage of Participants With Elevations of AST or ALT > 3 x ULN Concurrent With TBL > 2 x ULN During the OLE Phase | Elevations of AST or ALT > 3 x ULN concurrent with TBL > 2 x ULN were defined as elevations on the same collection date. Participants must have had a non-missing AST, ALT, or TBL measurement in the DBT phase to be included. | OLE Phase (Weeks 13 through 64) |
| Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the DBT Phase | Hepatic AEs were defined as all preferred terms in the DBT phase under the "Hepatic Disorders" Standardized Medical Dictionary (Version 21.1) for Regulatory Activities Query (SMQ), except those preferred terms in the "Congenital, Familial, Neonatal and Genetic Disorders of the Liver" SMQ. | Weeks 1 to 12 of the DBT phase |
| Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the OLE Phase | Hepatic AEs were defined as all preferred terms in the OLE phase under the "Hepatic Disorders" SMQ, except those preferred terms in the "Congenital, Familial, Neonatal and Genetic Disorders of the Liver" SMQ. | OLE Phase (Weeks 13 through 64) |
| Mean Change From Baseline in the Migraine Specific Quality of Life (MSQoL) Role Function-Restrictive Domain Score at Week 12 of the DBT Phase | The Migraine Specific Quality of Life (MSQoL) is a self-administered, 14-item instrument that has been validated in 3 domains: role restriction, role prevention, and the emotional function. The role function-restrictive domain consists of 7 items that describe how migraine limits one's daily social and work-related activities. Participants respond to items using a 6-point scale: "none of the time," "a little bit of the time," "some of the time," "a good bit of the time," "most of the time," and "all of the time," which are assigned scores of 1 to 6, respectively. Item scores are recoded using (7 - original score). Next, raw dimension scores are computed as a sum of recoded item scores and rescaled from a 0 to 100 scale such that higher scores indicate better quality of life. The change from baseline was calculated as the MSQoL restrictive role function domain score at Week 12 of the DBT phase minus the MSQoL restrictive role function domain score at baseline. | Baseline, Week 12 of the DBT Phase |
| Mean Change From Baseline in the Migraine Disability Assessment (MIDAS) Total Score at Week 12 of the DBT Phase | The Migraine Disability Assessment (MIDAS) is a retrospective, self-administered, 5-item questionnaire that measures headache-related disability as lost time due to headache from paid work or school, household work, and non-work activities. Participants provide the number of missed work or school days; missed household chores days; missed social or leisure activity days; and days at work or school, and separately at home, where productivity was reduced by half or more in the last 3 months (scale: 0 - 90 for each of 5 subscales). The 5 subscale scores are summed to compute the MIDAS total score (scale: 0 - 450). Lower scores indicate less headache-related disability. The change from baseline was calculated as the MIDAS total score at Week 12 of the DBT phase minus the MIDAS total score at baseline. | Baseline, Week 12 of the DBT Phase |
| Phoenix |
| Arizona |
| 85015 |
| United States |
| Tucson Neuroscience Research | Tucson | Arizona | 85710 | United States |
| Baptist Health Center for Clinical Research | Little Rock | Arkansas | 72205 | United States |
| Anaheim Clinical Trials | Anaheim | California | 92801 | United States |
| Axiom Research, LLC | Apple Valley | California | 92307 | United States |
| Axiom Research, LLC | Colton | California | 92324 | United States |
| eStudySite | La Mesa | California | 91942 | United States |
| Synergy San Diego | Lemon Grove | California | 91945 | United States |
| Collaborative Neuroscience Network, LLC | Long Beach | California | 90806 | United States |
| Pacific Research Partners, LLC | Oakland | California | 94607 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States |
| Optimus Medical Group | San Francisco | California | 94102 | United States |
| Artemis Institute for Clinical Research | San Marcos | California | 92078 | United States |
| Neurological Research Institute | Santa Monica | California | 90404 | United States |
| California Neuroscience Research Medical Group | Sherman Oaks | California | 91403 | United States |
| Ki Health Partners, LLC, dba New England Institute for Clinical Research | Stamford | Connecticut | 06905 | United States |
| Riverside Clinical Research | Edgewater | Florida | 32132 | United States |
| Galiz Research | Hialeah | Florida | 33016 | United States |
| Multi-Specialty Research Associates, Inc. | Lake City | Florida | 32055 | United States |
| Qps Mra, Llc | Miami | Florida | 33143 | United States |
| AppleMed Research Group, LLC | Miami | Florida | 33155 | United States |
| Harmony Clinical Research | North Miami Beach | Florida | 33162 | United States |
| Ormond Medical Arts Pharmaceutical Research Center | Ormond Beach | Florida | 32174 | United States |
| JSV Clinical Research Study Inc. | Tampa | Florida | 33634 | United States |
| Premiere Research Institute | West Palm Beach | Florida | 33407 | United States |
| iResearch Atlanta, LLC | Decatur | Georgia | 30030 | United States |
| Northwest Clinical Trials, Inc | Boise | Idaho | 83704 | United States |
| R&R Clinical Research | Idaho Falls | Idaho | 83404 | United States |
| Cedar Crosse Research Center | Chicago | Illinois | 60607 | United States |
| Family Medicine Specialists/CIS | Wauconda | Illinois | 60084 | United States |
| Community Clinical Research Center | Anderson | Indiana | 46011 | United States |
| Heartland Research Associates, LLC | Newton | Kansas | 67114 | United States |
| Phoenix Medical Research | Prairie Village | Kansas | 66208 | United States |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | United States |
| Crescent City Headache and Neurology Center | Chalmette | Louisiana | 70043 | United States |
| New Orleans Center for Clinical Research | New Orleans | Louisiana | 70119 | United States |
| DelRicht Research | New Orleans | Louisiana | 70124 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| ActivMed Practices & Research, Inc. | Methuen | Massachusetts | 01844 | United States |
| Regeneris Medical | North Attleboro | Massachusetts | 02760 | United States |
| Michigan Head Pain & Neurological Institute | Ann Arbor | Michigan | 48104 | United States |
| Michigan Pain Consultants | Grand Rapids | Michigan | 49503 | United States |
| MedPharmics, LLC | Biloxi | Mississippi | 39531 | United States |
| Clinical Research Professionals, Inc. | Chesterfield | Missouri | 63005 | United States |
| StudyMetrix Research | City of Saint Peters | Missouri | 63303 | United States |
| The Center for Pharmaceutical Research, LLC | Kansas City | Missouri | 64114 | United States |
| Clinvest Research LLC | Springfield | Missouri | 65810 | United States |
| Sundance Clinical Research, LLC | St Louis | Missouri | 63141 | United States |
| Meridian Clinical Research, LLC | Norfolk | Nebraska | 68701 | United States |
| Quality Clinical Research, Inc | Omaha | Nebraska | 68114 | United States |
| Nevada Headache Institute | Las Vegas | Nevada | 89113 | United States |
| Hassman Research Institute | Berlin | New Jersey | 08009 | United States |
| Albuquerque Neuroscience, Inc. | Albuquerque | New Mexico | 87109 | United States |
| Central New York Clinical Research | Manlius | New York | 13104 | United States |
| Mid Hudson Medical Research, PLLC | New Windsor | New York | 12553 | United States |
| Island Neurological, A Division of Prohealth Care Associates, LLP | Plainview | New York | 11803 | United States |
| Upstate Clinical Research Associates, LLC | Williamsville | New York | 14221 | United States |
| PharmQuest, LLC | Greensboro | North Carolina | 27408 | United States |
| PMG Research | Raleigh | North Carolina | 27609 | United States |
| Carolina Research Institute Center, Inc. | Shelby | North Carolina | 28150 | United States |
| Lillestol Research LLC | Fargo | North Dakota | 58104 | United States |
| Hometown Urgent Care | Cincinnati | Ohio | 45215 | United States |
| Hometown Urgent Care and Research | Dayton | Ohio | 45424 | United States |
| Neurology Diagnostics Research | Dayton | Ohio | 45459 | United States |
| Aventiv Research, Inc | Dublin | Ohio | 43016 | United States |
| Oklahoma Headache Center | Norman | Oklahoma | 73072 | United States |
| Tekton Research | Yukon | Oklahoma | 73099 | United States |
| Summit Research Network (Oregon) Inc. | Portland | Oregon | 97210 | United States |
| Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.) | Salem | Oregon | 97301 | United States |
| Clinical Research of Philadelphia, LLC | Philadelphia | Pennsylvania | 19114 | United States |
| BTC of Lincoln, LLC | Lincoln | Rhode Island | 02865 | United States |
| OnSite Clinical Solutions | Dillon | South Carolina | 29536 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| Meridian Clinical Research | Dakota Dunes | South Dakota | 57049 | United States |
| Volunteer Research Group | Knoxville | Tennessee | 37920 | United States |
| Tekton Research | Austin | Texas | 78745 | United States |
| FutureSearch Trials of Dallas, LP | Dallas | Texas | 75231 | United States |
| Ventavia Research Group, LLC | Fort Worth | Texas | 76104 | United States |
| North Texas Institute of Neurology & Headache | Frisco | Texas | 75034 | United States |
| Victorium Clinical Research | Houston | Texas | 77024 | United States |
| Texas Center for Drug Development, Inc. | Houston | Texas | 77081 | United States |
| Red Star Research, LLC | Lake Jackson | Texas | 77566 | United States |
| FMC Science | Lampasas | Texas | 76550 | United States |
| Victorium Clinical Research | San Antonio | Texas | 78230 | United States |
| DM Clinical Research | Tomball | Texas | 77375 | United States |
| Wasatch Clinical Research, LLC | Salt Lake City | Utah | 84107 | United States |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | United States |
| MedStar Georgetown Headache - Georgetown University | McLean | Virginia | 22102 | United States |
| Tidewater Integrated Medical Research | Virginia Beach | Virginia | 23454 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Seattle Women's | Seattle | Washington | 98105 | United States |
| Clinical Investigation Specialists, Inc. | Kenosha | Wisconsin | 53144 | United States |
| 36417057 | Derived | Powell LC, L'Italien G, Popoff E, Johnston K, O'Sullivan F, Harris L, Croop R, Coric V, Lipton RB. Health State Utility Mapping of Rimegepant for the Preventive Treatment of Migraine: Double-Blind Treatment Phase and Open Label Extension (BHV3000-305). Adv Ther. 2023 Feb;40(2):585-600. doi: 10.1007/s12325-022-02369-x. Epub 2022 Nov 22. |
| 33338437 | Derived | Croop R, Lipton RB, Kudrow D, Stock DA, Kamen L, Conway CM, Stock EG, Coric V, Goadsby PJ. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet. 2021 Jan 2;397(10268):51-60. doi: 10.1016/S0140-6736(20)32544-7. Epub 2020 Dec 15. |
| FG001 | DBT Placebo/OL Rimegepant | DBT phase (Weeks 1 through 12): Participants received a single oral dose of placebo matching to rimegepant tablet EOD for 12 weeks. OLE phase (Weeks 13 through 64): Participants who continued to meet study entry criteria and had acceptable laboratory test results per protocol, entered the OLE phase and received a single oral dose of rimegepant 75 mg tablet EOD for 52 weeks. If participants had a migraine on a day that they were not scheduled to dose with rimegepant, they could take one tablet of rimegepant 75 mg on that calendar day to treat a migraine (PRN dosing). After completing the OLE phase, participants had follow-up safety visits 2 and 8 weeks after the End-of-Treatment (EOT) visit. Participants who did not complete the DBT phase and/or did not enter or complete the OLE phase were to complete the EOT visit, the 2-week follow-up safety visit, and the 8-week follow-up safety visit after their early discontinuation. |
| COMPLETED |
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| NOT COMPLETED |
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| OLE Phase (Weeks 13 to 64) |
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| Follow-up Phase (up to 72 Weeks) |
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Participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rimegepant - Randomization Phase | Participants received a single oral dose of rimegepant 75 mg tablet EOD for 12 weeks. |
| BG001 | Placebo - Randomization Phase | Participants received a single oral dose of matching placebo tablet EOD for 12 weeks. |
| BG002 | 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in the Mean Number of Total Migraine Days Per Month in the Last 4 Weeks of the DBT Phase | A migraine day: any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache: a migraine with or without aura, lasting for ≥30 minutes, and meeting at least 1 of the following criteria (a and/or b): a) ≥2 of the following: unilateral location, pulsating quality, moderate to severe pain intensity, aggravation by or causing avoidance of routine physical activity; b) ≥1 of the following: nausea and/or vomiting, photophobia, and phonophobia. If the participant took a migraine-specific medication during aura or to treat headache on a calendar day, it was counted as a migraine day regardless of the duration and pain features/associated symptoms. Months were defined as 28-day intervals. The change from baseline was calculated as the number of monthly migraine days during the last 4 weeks of the DBT phase (Weeks 9 to 12) minus number of monthly migraine days during the OP. | The analysis was performed on evaluable modified intent to treat (mITT) participants. Evaluable participants are those with ≥ 14 days of electronic diary efficacy data (not necessarily consecutive) in both the OP and ≥ 1 month (4-week interval) in the DBT phase. | Posted | Least Squares Mean | 95% Confidence Interval | Total Migraine Days per Month | OP and Weeks 9 to 12 of the DBT phase |
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| Secondary | Number of Participants Who Had ≥ 50% Reduction in Moderate or Severe Migraine Days Per Month in the Last 4 Weeks of the DBT Phase | A migraine day was any calendar day in which the participant experienced a qualified migraine headache (as previously described). If the participant took a migraine-specific medication during aura or to treat headache on a calendar day, it was counted as a migraine day regardless of the duration and pain features/associated symptoms. A moderate or severe migraine day was a migraine day of moderate or severe pain intensity. Months were defined as 28-day intervals. A reduction of at least 50% in the mean number of moderate or severe monthly migraine days was determined if the number of moderate or severe monthly migraine days in the last 4 weeks of the DBT (Weeks 9 to 12) was less than or equal to half (50%) of the number of moderate or severe monthly migraine days in the OP. | The analysis was performed on evaluable mITT participants. | Posted | Number | 95% Confidence Interval | percentage of participants | OP and Weeks 9 to 12 of the DBT phase |
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| Secondary | Change From Baseline in the Mean Number of Migraine Days Per Month Over the Entire Course of the DBT Phase | A migraine day was any calendar day in which the participant experienced a qualified migraine headache (as previously described). If the participant took a migraine-specific medication during aura or to treat headache on a calendar day, it was counted as a migraine day regardless of the duration and pain features/associated symptoms. Months were defined as 28-day intervals. The change from baseline was calculated as the number of monthly migraine days during the DBT phase (Weeks 1 to 12) minus the number of monthly migraine days during the OP. | The analysis was performed on evaluable mITT participants. | Posted | Least Squares Mean | 95% Confidence Interval | Total Migraine Days per Month | OP and Weeks 1 to 12 of the DBT phase |
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| Secondary | Frequency of Use of Rescue Medication Days Per Month in the Last Month of the DBT Phase | A rescue medication day was a day on which the participant took triptan, ergotamine, or other permitted medication to acutely treat headache or aura. Months were defined as 28-day intervals. | The analysis was performed on evaluable mITT participants | Posted | Least Squares Mean | 95% Confidence Interval | rescue medication Days per Month | Weeks 9 to 12 of the DBT phase |
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| Secondary | Change From Baseline in the Mean Number of Total Migraine Days Per Month in the First Month of the DBT Phase | A migraine day was any calendar day in which the participant experienced a qualified migraine headache (as previously described). If the participant took a migraine-specific medication during aura or to treat headache on a calendar day, it was counted as a migraine day regardless of the duration and pain features/associated symptoms. Months were defined as 28-day intervals. The change from baseline was calculated as the number of monthly migraine days during the first 4 weeks of the DBT phase (Weeks 1 to 4) minus the number of monthly migraine days during the OP. | The analysis was performed on evaluable mITT participants. | Posted | Least Squares Mean | 95% Confidence Interval | migraine days per month | OP and Weeks 1 to 4 of the DBT phase |
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| Secondary | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation in the DBT Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition on-treatment in a patient or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. An SAE was defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received rimegepant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention. | The analysis was performed on the participants treated in the DBT phase. | Posted | Count of Participants | Participants | Weeks 1 to 12 of the DBT phase |
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| Secondary | Number of Participants With AEs, SAEs, AEs Leading to Study Drug Discontinuation in the OLE Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition on-treatment in a patient or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. An SAE was defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received rimegepant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention. | Open-Label (OL) rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date). | Posted | Count of Participants | Participants | OLE Phase (Weeks 13 through 64) |
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| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase | Clinically significant laboratory abnormalities were defined as Grade 3 to 4 laboratory test results according to numeric laboratory test criteria found in Common Technical Criteria for Adverse Events (CTCAE) Version 5.0 (2017) if available; otherwise, according to Division of Acquired Immune Deficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017) for glucose, LDL-cholesterol, uric acid, and urinalysis. Laboratory test groups of clinical interest included hematology, serum chemistry, and urinalysis. Participants must have had a non-missing measurement in the DBT phase to be included for a given parameter. | The analysis was performed on the participants treated in the DBT phase. | Posted | Count of Participants | Participants | Weeks 1 to 12 of the DBT phase |
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| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase | Clinically significant laboratory abnormalities were defined as Grade 3 to 4 laboratory test results according to numeric laboratory test criteria found in CTCAE Version 5.0 (2017) if available; otherwise, according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017) for glucose, LDL-cholesterol, uric acid, and urinalysis. Laboratory test groups of clinical interest included hematology, serum chemistry, and urinalysis. Participants must have had a non-missing measurement in the OLE phase to be included for a given parameter. | OL rimegepant treated participants with available data were included in the analysis. | Posted | Count of Participants | Participants | OLE Phase (Weeks 13 through 64) |
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| Secondary | Number of Participants With Elevations of AST or ALT > 3 x Upper Limit of Normal (ULN) Concurrent With Total Bilirubin (TBL) > 2 x ULN During the DBT Phase | Elevations of AST or ALT > 3 x ULN concurrent with TBL > 2 x ULN were defined as elevations on the same collection date. Participants must have had a non-missing AST, ALT, or TBL measurement in the OLE phase to be included. | The analysis was performed on the participants treated in the DBT phase. | Posted | Number | 95% Confidence Interval | Percentage of participants | Weeks 1 to 12 of the DBT phase |
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| Secondary | Percentage of Participants With Elevations of AST or ALT > 3 x ULN Concurrent With TBL > 2 x ULN During the OLE Phase | Elevations of AST or ALT > 3 x ULN concurrent with TBL > 2 x ULN were defined as elevations on the same collection date. Participants must have had a non-missing AST, ALT, or TBL measurement in the DBT phase to be included. | OL rimegepant treated participants with available data were included in the analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | OLE Phase (Weeks 13 through 64) |
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| Secondary | Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the DBT Phase | Hepatic AEs were defined as all preferred terms in the DBT phase under the "Hepatic Disorders" Standardized Medical Dictionary (Version 21.1) for Regulatory Activities Query (SMQ), except those preferred terms in the "Congenital, Familial, Neonatal and Genetic Disorders of the Liver" SMQ. | The analysis was performed on the participants treated in the DBT phase. | Posted | Count of Participants | Participants | Weeks 1 to 12 of the DBT phase |
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| Secondary | Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the OLE Phase | Hepatic AEs were defined as all preferred terms in the OLE phase under the "Hepatic Disorders" SMQ, except those preferred terms in the "Congenital, Familial, Neonatal and Genetic Disorders of the Liver" SMQ. | OL rimegepant treated participants were included in the analysis. | Posted | Count of Participants | Participants | OLE Phase (Weeks 13 through 64) |
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| Secondary | Mean Change From Baseline in the Migraine Specific Quality of Life (MSQoL) Role Function-Restrictive Domain Score at Week 12 of the DBT Phase | The Migraine Specific Quality of Life (MSQoL) is a self-administered, 14-item instrument that has been validated in 3 domains: role restriction, role prevention, and the emotional function. The role function-restrictive domain consists of 7 items that describe how migraine limits one's daily social and work-related activities. Participants respond to items using a 6-point scale: "none of the time," "a little bit of the time," "some of the time," "a good bit of the time," "most of the time," and "all of the time," which are assigned scores of 1 to 6, respectively. Item scores are recoded using (7 - original score). Next, raw dimension scores are computed as a sum of recoded item scores and rescaled from a 0 to 100 scale such that higher scores indicate better quality of life. The change from baseline was calculated as the MSQoL restrictive role function domain score at Week 12 of the DBT phase minus the MSQoL restrictive role function domain score at baseline. | The analysis was performed on evaluable mITT participants. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Week 12 of the DBT Phase |
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| Secondary | Mean Change From Baseline in the Migraine Disability Assessment (MIDAS) Total Score at Week 12 of the DBT Phase | The Migraine Disability Assessment (MIDAS) is a retrospective, self-administered, 5-item questionnaire that measures headache-related disability as lost time due to headache from paid work or school, household work, and non-work activities. Participants provide the number of missed work or school days; missed household chores days; missed social or leisure activity days; and days at work or school, and separately at home, where productivity was reduced by half or more in the last 3 months (scale: 0 - 90 for each of 5 subscales). The 5 subscale scores are summed to compute the MIDAS total score (scale: 0 - 450). Lower scores indicate less headache-related disability. The change from baseline was calculated as the MIDAS total score at Week 12 of the DBT phase minus the MIDAS total score at baseline. | The analysis was performed on evaluable mITT participants | Posted | Mean | 95% Confidence Interval | Scores on a scale | Baseline, Week 12 of the DBT Phase |
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DBT Phase: From the first dose in the DBT Phase (Week 1) to Week 12 OLE Phase: Week 13 to Week 64 Follow-up phase: 8 weeks after the end of treatment (maximum duration of treatment: 64 weeks)
AEs are presented according to the periods of the study.
Randomized phase: Participants treated in the DBT phase were included.
OLE phase: OL rimegepant treated participants included enrolled participants who received at least one dose of OL rimegepant (non-missing OL rimegepant start date).
Follow-up phase: Follow-up participants included all treated participants whose last contact date was in the follow-up safety analysis period.
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 | Rimegepant - Randomization Phase | Participants received a single oral dose of rimegepant 75 mg tablet EOD for 12 weeks. | 0 | 370 | 3 | 370 | 0 | 370 |
| EG001 | Placebo - Randomization Phase | Participants received a single oral dose of matching placebo tablet EOD for 12 weeks. | 0 | 371 | 4 | 371 | 0 | 371 |
| EG002 | DBT Rimegepant/OLE Rimegepant - OLE Phase | OLE Phase (Weeks 13 through 64): After completion of DBT phase, participants, who continued to meet study entry criteria and had acceptable laboratory test results per protocol, entered the OLE phase and received a single oral dose of rimegepant 75 mg tablet EOD for 52 weeks. If participants had a migraine on a day that they were not scheduled to dose with rimegepant, they could take one tablet of rimegepant 75 mg on that calendar day to treat a migraine (as needed [PRN] dosing). | 1 | 302 | 7 | 302 | 41 | 302 |
| EG003 | DBT Placebo/OLE Rimegepant - OLE Phase | OLE Phase (Weeks 13 through 64): After completion of DBT phase, participants, who continued to meet study entry criteria and had acceptable laboratory test results per protocol, entered the OLE phase and received a single oral dose of rimegepant 75 mg tablet EOD for 52 weeks. If participants had a migraine on a day that they were not scheduled to dose with rimegepant, they could take one tablet of rimegepant 75 mg on that calendar day to treat a migraine (PRN dosing). | 1 | 301 | 6 | 301 | 37 | 301 |
| EG004 | DBT Rimegepant/OLE Rimegepant - Follow-up Phase | Participants received rimegepant during the DBT phase (Week 1 to Week 12) and OLE phase (Week 13 to Week 64). After completing the OLE phase, participants had follow-up safety visits 2 and 8 weeks after the EOT visit. Participants who did not complete the DBT phase and/or did not enter or complete the OLE phase were to complete the EOT visit, the 2-week follow-up safety visit, and the 8-week follow-up safety visit after their early discontinuation. | 0 | 332 | 2 | 332 | 41 | 332 |
| EG005 | DBT Placebo/OLE Rimegepant - Follow-up Phase | Participants received placebo during the DBT phase (Week 1 to Week 12) and rimegepant OLE phase (Week 13 to Week 64). After completing the OLE phase, participants had follow-up safety visits 2 and 8 weeks after the EOT visit. Participants who did not complete the DBT phase and/or did not enter or complete the OLE phase were to complete the EOT visit, the 2-week follow-up safety visit, and the 8-week follow-up safety visit after their early discontinuation. | 0 | 336 | 2 | 336 | 34 | 336 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Depressive delusion | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Aortic dissection | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
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| Acute hepatitis B | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding study results for a period that is less than or equal to 60 days from the date that the communication is submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot unilaterally extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Biohaven Pharmaceuticals, Inc. | 203-404-0410 | clinicaltrials@biohavenpharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 16, 2021 | Nov 4, 2022 | SAP_002.pdf |
Not provided
| 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 |
|---|---|
| C578443 | rimegepant sulfate |
Not provided
Not provided
Not provided
| Extension phase eligibility failure due to week 12 laboratory values |
|
| Lack of Efficacy |
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| Lost to Follow-up |
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| Non-compliance |
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| Physician Decision |
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| Pregnancy |
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| Protocol deviation |
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| Sponsor Recommendation |
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| Withdrawal by Subject |
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| Other than specified |
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| Non-compliance |
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| Withdrawal by Subject |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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| Participants |
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| OG001 | DBT Placebo/OL Rimegepant | OLE Phase (Weeks 13 through 64): After completion of DBT phase, participants who continued to meet study entry criteria and had acceptable laboratory test results per protocol, entered the OLE phase and received a single oral dose of rimegepant 75 mg tablet EOD for 52 weeks. If participants had a migraine on a day that they were not scheduled to dose with rimegepant, they could take one tablet of rimegepant 75 mg on that calendar day to treat a migraine (PRN dosing). |
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| Counts |
|---|
| Participants |
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Participants received a single oral dose of matching placebo tablet EOD for 12 weeks.
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| Units | Counts |
|---|---|
| Participants |
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