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

NCT ID: NCT03934086

Last Updated: 2023-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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Conditions

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Migraine

Interventions

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rimegepant

rimegepant 75 mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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BHV3000-401

Identifier Type: -

Identifier Source: org_study_id

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