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Safety and Efficacy Study in Adult Subjects With Acute Migraines

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03235479
First Posted: August 1, 2017
Last Update Posted: November 29, 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. Read our disclaimer for details.
Information provided by (Responsible Party):
Biohaven Pharmaceutical Holding Company Ltd.
  Purpose
The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant) versus placebo in subjects with Acute Migraines

Condition Intervention Phase
Migraine Acute Migraine Phonophobia Photophobia Drug: BHV-3000 Drug: Placebo Oral Tablet Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Double-blind to Sponsor, Investigator and Subject Randomized Controlled Trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Double-blind to Sponsor, Investigator and Subject
Primary Purpose: Treatment
Official Title: BHV3000-301: Phase 3: Double-Blind, Randomized, Placebo-Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) for the Acute Treatment of Migraine

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pain freedom of rimegepant (75 mg tablet) compared with placebo in the acute treatment of migraine will be measured using the number of evaluable subjects that report no pain at 2 hours post-dose. [ Time Frame: Two hours post dose ]
    Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)

  • Freedom from the most bothersome symptom (MBS) of rimegepant (75 mg tablet) compared with placebo will be measured using the number of evaluable subjects that report the absence of their MBS at 2 hours post-dose. [ Time Frame: Two hours post dose ]
    The MBS (nausea, phonophobia or photophobia) will measured using a binary scale (0=absent, 1=present).


Secondary Outcome Measures:
  • To measure the difference between rimegepant (75 mg tablet) compared to placebo from 2 to 24 hours, using the number of subjects that do not experience any headache pain through the time period of interest. [ Time Frame: 2 hours -24 hours post-dose ]
    Sustained Pain Freedom as measured by a 4 point numeric rating scale (None, Mild, Moderate, Severe)

  • The difference between rimegepant (75 mg tablet) compared to placebo by tabulating the absence of photophobia at 2 hours post-dose in the subset of subjects that reported the presence of photophobia at headache baseline. [ Time Frame: 2 hours post-dose ]
    Photophobia

  • To evaluate rimegepant (75 mg tablet) compared to placebo by tabulating the number of subjects that report the absence of phonophobia at 2 hours post-dose in the subset of subjects that reported the presence of phonophobia at headache baseline. [ Time Frame: 2 hours post-dose ]
    Phonophobia

  • To measure the difference between rimegepant (75 mg tablet) compared to placebo on Pain Relief, at 2 hours post-dose, for those that report a pain level of moderate or severe at baseline and then report a pain level of none or mild. [ Time Frame: 2 hours post-dose ]
    Pain Relief as measured by a 4 point numeric rating scale (None, Mild, Moderate, Severe)

  • Freedom from Nausea by tabulating the number of subjects that report the absence of nausea at 2 hours post-dose in the subset of subjects that reported the presence of nausea at headache baseline. [ Time Frame: 2 hours post-dose ]
    Freedom from Nausea

  • The difference between rimegepant (75 mg tablet) compared to placebo on the probability of requiring rescue medication using the number of subjects that take rescue medication within 24 after administration of study medication (BHV3000 or placebo). [ Time Frame: up to 24 hours post-dose ]
    Requiring Rescue Medication

  • To measure the difference between rimegepant (75 mg tablet) compared to placebo on sustained pain freedom, from 2 to 48 hours, using the number of subjects that do not experience any headache pain through the time period of interest. [ Time Frame: 2 hours - 24 hours post-dose ]
    Sustained Pain Freedom

  • Rimegepant (75 mg tablet) compared to placebo on sustained pain relief, from 2 to 24 hours by using the number of subjects that do not use any rescue medications, and do not experience any moderate or severe headache pain through that time. [ Time Frame: 2 hours- 24 hours post-dose ]
    Sustained Pain Relief as measured by a 4 point numeric rating scale (None, Mild, Moderate, Severe)

  • To measure the difference between rimegepant (75 mg tablet) compared to placebo on sustained pain relief from 2 to 48 hours, using the number of subjects that do not use any rescue medications and do not experience moderate to severe headache pain. [ Time Frame: 2 hours - 48 hours post-dose ]
    Sustained Pain Relief as measured by a 4 point numeric rating scale (None, Mild, Moderate, Severe)

  • To measure the difference between rimegepant (75 mg tablet) relative to placebo on the proportion of subjects able to function normally, at 2 hours, using the number of subjects that self-report as "normal" on the functional disability scale. [ Time Frame: 2 hours post-dose ]
    Functional Disability Score

  • To measure the difference between rimegepant (75 mg tablet) compared to placebo on pain relapse using the number of subjects that are pain free at 2 hours post-dose and then have a headache of any severity within 48 hours of study medication. [ Time Frame: 2 hours to 48 hours post-dose ]
    Pain relapse as measured by a 4 point numeric rating scale (None, Mild, Moderate, Severe)


Enrollment: 1490
Actual Study Start Date: July 18, 2017
Estimated Study Completion Date: January 30, 2018
Estimated Primary Completion Date: January 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BHV-3000 Drug: BHV-3000
75 mg tablet QD
Placebo Comparator: Placebo Drug: Placebo Oral Tablet
equivalent of 75 mg tablet QD

  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:

  1. Patient has at least 1 year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, Beta version[1] including the following:

    • Not more than 8 attacks of moderate or severe intensity per month within last 3 months
    • Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period
  2. Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period
  3. Patients on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to study entry.
  4. Patients with contraindications for use of triptans may be included provided they meet all other study entry criteria.

Exclusion Criteria:

  1. Patient history of HIV disease
  2. Patient history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients 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.
  3. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however patients can be included who have stable hypertension and/or diabetes for 3 months prior to being enrolled)
  4. Patient has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (eg, schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments
  5. Patient has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption
  6. The patient has a history or current evidence of any significant and/or unstable medical conditions (eg, history of congenital heart disease or arrhythmia, known 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
  7. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or patients who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit.
  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): NCT03235479


  Show 50 Study Locations
Sponsors and Collaborators
Biohaven Pharmaceutical Holding Company Ltd.
  More Information

Responsible Party: Biohaven Pharmaceutical Holding Company Ltd.
ClinicalTrials.gov Identifier: NCT03235479     History of Changes
Other Study ID Numbers: BHV-3000-301
First Submitted: July 14, 2017
First Posted: August 1, 2017
Last Update Posted: November 29, 2017
Last Verified: November 2017

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

Additional relevant MeSH terms:
Migraine Disorders
Photophobia
Hyperacusis
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases