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Open Label Safety Study in Acute Treatment of Migraine

This study is currently recruiting participants.
Verified November 2017 by Biohaven Pharmaceutical Holding Company Ltd.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03266588
First Posted: August 30, 2017
Last Update Posted: November 15, 2017
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.
Information provided by (Responsible Party):
Biohaven Pharmaceutical Holding Company Ltd.
  Purpose
The purpose of this study is to evaluate safety and tolerability of BHV3000 (rimegepant).

Condition Intervention Phase
Migraine Drug: Rimegepant Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Biohaven Pharmaceutical Holding Company Ltd.:

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

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


Estimated Enrollment: 2000
Actual Study Start Date: August 30, 2017
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rimegepant Drug: Rimegepant
75 mg oral tablet
Other Name: BHV3000

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with 2-14 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
  Contacts and Locations
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): NCT03266588


  Show 98 Study Locations
Sponsors and Collaborators
Biohaven Pharmaceutical Holding Company Ltd.
  More Information

Responsible Party: Biohaven Pharmaceutical Holding Company Ltd.
ClinicalTrials.gov Identifier: NCT03266588     History of Changes
Other Study ID Numbers: BHV3000-201
First Submitted: August 23, 2017
First Posted: August 30, 2017
Last Update Posted: November 15, 2017
Last Verified: November 2017
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 Pharmaceutical Holding Company Ltd.:
migraine
acute

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