Open Label Safety Study in Acute Treatment of Migraine
Purpose
The purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant).
Condition
- Migraine, With or Without Aura
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
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%
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Rimegepant |
|
More Details
- Status
- Completed
- Sponsor
- Pfizer