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Purpose

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

Condition

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.