Open Label Safety Study in Acute Treatment of Migraine

Pfizer

Status and phase: Completed; Phase 3; Phase 2

Conditions: Migraine, With or Without Aura

Treatments: Drug: Rimegepant

Study type: Interventional

Funder types: Industry

Identifiers

NCT03266588

BHV3000-201

Details and patient eligibility

About

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

Enrollment: 3,019 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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%

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,019 participants in 1 patient group

Rimegepant

Experimental group

Treatment:

Drug: Rimegepant