Phase 3
Completed N=741
Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults
Source: ClinicalTrials.gov NCT03732638 ↗Enrolled (actual)
741
Serious AEs
1.2%
Results posted
Aug 2021
Primary outcomePrimary: Change From Baseline in the Mean Number of Total Migraine Days Per Month in the Last 4 Weeks of the DBT Phase — -4.3; -3.5 Total Migraine Days per Month — p=0.0099
◆ Published Evidence
Highly cited
350citations · ~70 / year
Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial.
Summary
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.
Linked Publications (4)
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Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial.
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Health State Utility Mapping of Rimegepant for the Preventive Treatment of Migraine: Double-Blind Treatment Phase and Open Label Extension (BHV3000-305).
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A 52-week open-label extension study to evaluate the safety and efficacy of oral rimegepant for the preventive treatment of migraine.
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Comparative effectiveness of erenumab versus rimegepant for migraine prevention using matching-adjusted indirect comparison.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Mean Number of Total Migraine Days Per Month in the Last 4 Weeks of the DBT Phase |
-4.3; -3.5 | 0.0099 sig |
| 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 |
49.1; 41.5 | 0.0438 sig |
| SECONDARY Change From Baseline in the Mean Number of Migraine Days Per Month Over the Entire Course of the DBT Phase |
-3.6; -2.7 | 0.0017 sig |
| SECONDARY Frequency of Use of Rescue Medication Days Per Month in the Last Month of the DBT Phase |
3.7; 4.0 | 0.3868 |
| SECONDARY Change From Baseline in the Mean Number of Total Migraine Days Per Month in the First Month of the DBT Phase |
-2.9; -1.7 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation in the DBT Phase |
133; 133; 3; 4; 7; 4 | — |
| SECONDARY Number of Participants With AEs, SAEs, AEs Leading to Study Drug Discontinuation in the OLE Phase |
150; 162; 7; 6; 9; 8 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Abnormalities in the DBT Phase |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Abnormalities in the OLE Phase |
0; 0; 1; 1; 0; 0 | — |
| 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 |
0; 0 | — |
| SECONDARY Percentage of Participants With Elevations of AST or ALT > 3 x ULN Concurrent With TBL > 2 x ULN During the OLE Phase |
0; 0 | — |
| SECONDARY Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the DBT Phase |
6; 2; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the OLE Phase |
2; 9; 0; 1; 0; 0 | — |
| 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 |
18.0; 14.6 | — |
| SECONDARY Mean Change From Baseline in the Migraine Disability Assessment (MIDAS) Total Score at Week 12 of the DBT Phase |
-11.8; -11.7 | — |
Eligibility Criteria
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:
- Age of onset of migraines prior to 50 years of age
- Migraine attacks, on average, lasting 4 - 72 hours if untreated
- Per subject report, 4 - 18 migraine attacks of moderate to severe intensity per month within the last 3 months prior to the Screening Visit
- 6 or more migraine days during the Observation Period
- Not more than 18 headache days during the Observation Period
- Ability to distinguish migraine attacks from tension/cluster headaches
- Subjects on prophylactic migraine medication are permitted to remain on 1 medication with possible migraine-prophylactic effects if the dose has been stable for at least 3 months prior to the Screening Visit, and the dose is not expected to change during the course of the study.
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.
Data sourced from ClinicalTrials.gov (NCT03732638) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.