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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03934086
Expanded Access Status : Available
First Posted : May 1, 2019
Last Update Posted : September 16, 2019
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT03934086

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Contact: Early Access Care 203-779-8501

Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.

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Responsible Party: Biohaven Pharmaceuticals, Inc. 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