Open Label Safety Study in 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. Read our disclaimer for details. Identifier: NCT03266588
Recruitment Status : Active, not recruiting
First Posted : August 30, 2017
Last Update Posted : November 1, 2018
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

Brief Summary:
The purpose of this study is to evaluate safety and tolerability of BHV3000 (rimegepant).

Condition or disease Intervention/treatment Phase
Migraine Drug: Rimegepant Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open Label Long-Term Safety Study of BHV3000 in the Acute Treatment of Migraine
Actual Study Start Date : August 30, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Rimegepant Drug: Rimegepant
75 mg oral tablet
Other Name: BHV3000

Primary Outcome Measures :
  1. To assess the safety and tolerability of rimegepant (BHV-3000) by measuring the frequency and severity of adverse events and discontinuations due to adverse events [ Time Frame: 52 weeks ]
    Number of subjects with treatment-emergent adverse events as assessed through laboratory tests, ECGs, physical exam findings (safety and tolerability)

Secondary Outcome Measures :
  1. ALT or AST > 3x ULN with total bilirubin >2x ULN [ Time Frame: 52 weeks ]
    elevated liver function tests

  2. hepatic related adverse events and hepatic related adverse events that lead to discontinuation [ Time Frame: 52 weeks ]
    adverse events related to liver

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
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects with 4-14 moderate to severe migraines/month
  • Age of onset of migraines prior to 50 years of age
  • Migraine attacks, on average, lasting 4-72 hours if untreated
  • Ability to distinguish migraine attacks from tension/cluster headaches
  • Patients with contraindications for use of triptans may be included provided they meet all other study entry criteria

Exclusion Criteria:

  • History of basilar migraine or hemiplegic migraine
  • History of HIV disease
  • History with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia.
  • Uncontrolled hypertension or uncontrolled diabetes (however, patients can be included who have stable hypertension and /or diabetes for 3 months prior to screening
  • History of gastric or small intestinal surgery or has a disease that causes malabsorption
  • BMI ≥ 30
  • HbA1c ≥ 6.5%

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): NCT03266588

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Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.

Responsible Party: Biohaven Pharmaceuticals, Inc. Identifier: NCT03266588     History of Changes
Other Study ID Numbers: BHV3000-201
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Biohaven Pharmaceuticals, Inc.:

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases