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
About this trial
This is an expanded access trial for Migraine focused on measuring Migraine prevention, phonophobia, photophobia, nausea
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
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
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Primary Completion Date
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Study Completion Date
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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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