Open Label Safety Study in Acute Treatment of Migraine

• Status: Completed
• Trial end date: 2019-07-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate safety and tolerability of BHV-3000 (rimegepant).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biohaven Pharmaceutical Holding Company Ltd.; Biohaven Pharmaceuticals, Inc.

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%