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

ArmDescriptionAssigned Intervention
Experimental
Rimegepant
  • Drug: Rimegepant
    75 mg oral tablet
    Other names:
    • BHV-3000

More Details

Status
Completed
Sponsor
Pfizer

Study Contact