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

Primary Purpose

Migraine

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
rimegepant
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Migraine focused on measuring Migraine prevention, phonophobia, photophobia, nausea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    April 29, 2019
    Last Updated
    February 21, 2023
    Sponsor
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03934086
    Brief Title
    An Open-label, Intermediate Size, Expanded Access Study of BHV-3000 in the Acute Treatment of Migraine
    Official Title
    BHV3000-401: An Open-label, Intermediate-size, Expanded Access Study of BHV-3000 in the Acute Treatment of Migraine
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pfizer

    4. Oversight

    5. 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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Migraine
    Keywords
    Migraine prevention, phonophobia, photophobia, nausea

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    rimegepant
    Intervention Description
    rimegepant 75 mg

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: 1.Subjects who have completed any BHV3000 (rimegepant) clinical study without significant protocol violations. Exclusion Criteria: History of basilar migraine or hemiplegic migraine History with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease HIV history Uncontrolled hypertension or uncontrolled diabetes 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 History of gastric, or small intestinal surgery, or has a disease that causes malabsorption

    12. IPD Sharing Statement

    Learn more about this trial

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

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