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

Pfizer

Status

Conditions: Migraine

Treatments: Drug: rimegepant

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT03934086

BHV3000-401

Details and patient eligibility

About

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)

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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