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Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults

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ClinicalTrials.gov Identifier: NCT03732638
Recruitment Status : Active, not recruiting
First Posted : November 6, 2018
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

Brief Summary:
The purpose of this is study is to compare the efficacy of BHV-3000 (rimegepant) to placebo as a preventive treatment for migraine, as measured by the reduction in the number of migraine days per month.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1629 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 2/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention
Actual Study Start Date : November 14, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Active Comparator: BHV-3000 (Rimegepant) Drug: Rimegepant
BHV-3000 (rimegepant) 75 mg tablet

Placebo Comparator: Placebo Comparator Drug: Placebo
75mg matching placebo




Primary Outcome Measures :
  1. Change from baseline in mean number of migraine days per month [ Time Frame: Mean number of migraine days per month as assessed over 3 months (12 weeks) ]
    Change from baseline in mean number of migraine days per month as measured over the 12-week double-blind phase of the study.


Secondary Outcome Measures :
  1. Achievement of at least a 50% reduction from baseline in mean monthly migraine days. [ Time Frame: baseline to end of Week 12 ]
    Achievement of at least a 50% reduction from baseline in mean monthly migraine days over course of the double-blind treatment phase.

  2. The mean number of rescue medication days per month. [ Time Frame: baseline to end of week 12 as measure per month ]
    The mean number of rescue medication days per month over the course of the double-blind, treatment phase. Rescue medications include the rescue medications defined in this protocol.

  3. Adverse events. [ Time Frame: baseline to end of Week 12 ]
    Adverse events that occur in at least 5% of treated subjects; the frequency of unique subjects with serious adverse events, adverse events leading to discontinuation and clinically significant laboratory abnormalities, as reported on case report forms.

  4. The frequency of AST or ALT elevations. [ Time Frame: baseline to end of Week 12 ]
    The frequency of AST or ALT elevations > 3x ULN, concurrently with bilirubin elevations > 2x ULN, will be assessed by tabulating the number of unique subjects with this pairing of events.

  5. The frequency of hepatic-related adverse events and hepatic-related treatment. [ Time Frame: baseline to end of Week 12 ]
    The frequency of hepatic-related adverse events and hepatic-related treatment discontinuations will be tabulated from case report forms and will be based on unique subjects reporting such events.

  6. The mean change from baseline in the MSQ role function [ Time Frame: baseline to end of Week 12 ]
    The mean change from baseline in the MSQ role function - restrictive domain score at Week 12 of the double-blind treatment phase.



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
Criteria

Inclusion Criteria:

  1. Subject has at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:

    1. Age of onset of migraines prior to 50 years of age
    2. Migraine attacks, on average, lasting 4 - 72 hours if untreated
    3. Per subject report, 4 - 18 migraine attacks of moderate to severe intensity per month within the last 3 months prior to the Screening Visit
    4. 6 or more migraine days during the Observation Period
    5. Not more than 18 headache days during the Observation Period
    6. Ability to distinguish migraine attacks from tension/cluster headaches
    7. Subjects on prophylactic migraine medication are permitted to remain on 1 medication with possible migraine-prophylactic effects if the dose has been stable for at least 3 months prior to the Screening Visit, and the dose is not expected to change during the course of the study.

    Exclusion Criteria:

  2. Subject with a history of HIV disease
  3. Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening
  4. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to screening).
  5. Subjects with major depressive episode within the last 12 months, major depressive disorder or any anxiety disorder requiring more than 1 medication for each disorder. Medications to treat major depressive disorder or an anxiety disorder must have been at a stable dose for at least 3 months prior to the Screening visit.
  6. Subjects with other pain syndromes, psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments
  7. Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease that causes malabsorption
  8. Body mass index ≥ 33 kg/m2
  9. Subject has current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder
  10. History of gallstones or cholecystectomy.
  11. The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial.

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): NCT03732638


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Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.

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Responsible Party: Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03732638     History of Changes
Other Study ID Numbers: BHV3000-305
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019

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