Phase 3
Completed N=2,867
Open Label Safety Study in Acute Treatment of Migraine
Migraine, With or Without Aura
Source: ClinicalTrials.gov NCT03266588 ↗
Enrolled (actual)
2,867
Serious AEs
2.6%
Results posted
Jul 2020
Primary outcomePrimary: Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period — 664; 315; 109; 108 Participants
◆ Published Evidence
Established
42citations · ~21 / year
A multicenter, open-label long-term safety study of rimegepant for the acute treatment of migraine.
Summary
The purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant).
Linked Publications (5)
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A multicenter, open-label long-term safety study of rimegepant for the acute treatment of migraine.
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Safety of Rimegepant in Adults with Migraine and Cardiovascular Risk Factors: Analysis of a Multicenter, Long-Term, Open-Label Study.
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Long-Term Use of Rimegepant 75 mg for the Acute Treatment of Migraine is Associated with a Reduction in the Utilization of Select Analgesics and Antiemetics.
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Rimegepant safety and patient-reported outcomes among triptan-naïve, triptan-using, and triptan-failure participants: Subgroup analysis of an open-label, multicenter study.
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Safety of Rimegepant in Adults with Migraine and Anxiety, Depression, or Using Antidepressants: Analysis of a Multicenter, Long-Term, Open-Label Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period |
664; 315; 109; 108; 38; 12 | — |
| PRIMARY Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period |
3; 2; 0; 4; 2; 0 | — |
| SECONDARY Percentage of Participants With Elevations of AST or ALT > 3 x Upper Limit of Normal (ULN) Concurrent With Total Bilirubin > 2 x ULN During the Treatment Period |
0.1; 0; 0 | — |
| SECONDARY Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the Treatment Period |
16; 10; 0; 3; 3; 0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Subjects with 2-8 moderate to severe migraines/month
- Age of onset of migraines prior to 50 years of age
- Migraine attacks, on average, lasting 4-72 hours if untreated
- Ability to distinguish migraine attacks from tension/cluster headaches
- Patients with contraindications for use of triptans may be included provided they meet all other study entry criteria
Key Exclusion Criteria
- History of basilar migraine or hemiplegic migraine
- History of HIV disease
- History with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia.
- Uncontrolled hypertension or uncontrolled diabetes (however, patients can be included who have stable hypertension and /or diabetes for 3 months prior to screening
- History of gastric or small intestinal surgery or has a disease that causes malabsorption
- BMI ≥ 30
- HbA1c ≥ 6.5%
Data sourced from ClinicalTrials.gov (NCT03266588) 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.