An Open-label, Intermediate Size, Expanded Access Study of BHV-3000 in the Acute Treatment of Migraine

• Conditions: Migraine

• Registration Number: NCT03934086
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this protocol is to allow subjects who completed any BHV3000 (rimegepant) clinical study to continue to have access to rimegepant while collecting ongoing safety data.

(NOTE: ONLY FOR PATIENTS who participated in a previous BHV-3000/Rimegepant Clinical Trial in the past)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-29
• Study First Submitted QC: 2019-04-29
• Study First Posted: 2019-05-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Subjects who have completed any BHV3000 (rimegepant) clinical study without significant protocol violations.

Exclusion Criteria

1. History of basilar migraine or hemiplegic migraine
2. History with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease
3. HIV history
4. Uncontrolled hypertension or uncontrolled diabetes
5. Current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments
6. History of gastric, or small intestinal surgery, or has a disease that causes malabsorption

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified