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

Sponsor
Biohaven Pharmaceuticals, Inc. (Industry)
Overall Status
No longer available
CT.gov ID
NCT03934086
Collaborator
(none)

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase

Study Design

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Biohaven Pharmaceuticals, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biohaven Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT03934086
    Other Study ID Numbers:
    • BHV3000-401
    First Posted:
    May 1, 2019
    Last Update Posted:
    Mar 3, 2020
    Last Verified:
    Feb 1, 2020
    Keywords provided by Biohaven Pharmaceuticals, Inc.
    Migraine prevention, phonophobia, photophobia, nausea
    Additional relevant MeSH terms:
    Migraine Disorders

    Study Results

    No Results Posted as of Mar 3, 2020