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

Last updated: February 21, 2023
Sponsor: Pfizer
Overall Status: Trial Not Available

Phase

N/A

Condition

Oral Facial Pain

Pain

Migraine (Adult)

Treatment

N/A

Clinical Study ID

NCT03934086
BHV3000-401
  • Ages > 18
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. History of basilar migraine or hemiplegic migraine
  2. History with current evidence of uncontrolled, unstable or recently diagnosedcardiovascular 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 thanmigraine) that, in the Investigator's opinion, might interfere with study assessments
  6. History of gastric, or small intestinal surgery, or has a disease that causesmalabsorption

Study Design

Study Start date:
Estimated Completion Date: