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

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ClinicalTrials.gov Identifier: NCT03934086
Expanded Access Status : Available
First Posted : May 1, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

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
Migraine Drug: rimegepant

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine


Intervention Details:
  • Drug: rimegepant
    rimegepant 75 mg

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03934086


Contacts
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Contact: Early Access Care 203-779-8501 ExpandedAccess@EarlyAccessCare.com

Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.

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Responsible Party: Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03934086     History of Changes
Other Study ID Numbers: BHV3000-401
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Keywords provided by Biohaven Pharmaceuticals, Inc.:
Migraine prevention, phonophobia, photophobia, nausea
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases