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NCT03934086 Clinical Trial

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

Migraine Clinical Trial

Official title:
BHV3000-401: An Open-label, Intermediate-size, Expanded Access Study of BHV-3000 in the Acute Treatment of Migraine

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT03934086
Other study ID # BHV3000-401
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date February 2023
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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)

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• rimegepant
rimegepant 75 mg

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer
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