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Trial in Adult Subjects With Acute Migraines

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ClinicalTrials.gov Identifier: NCT03461757
Recruitment Status : Completed
First Posted : March 12, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

Brief Summary:
The purpose of this study is to compare the efficacy of BHV-3000 (rimegepant ODT) versus placebo in subjects with Acute Migraines.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1812 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: BHV3000-303: Phase 3, Double-Blind, Randomized, Placebo Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) Orally Disintegrating Tablet (ODT) for the Acute Treatment of Migraine
Actual Study Start Date : February 27, 2018
Actual Primary Completion Date : October 8, 2018
Actual Study Completion Date : October 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Arm 1: BHV-3000 (Active) Drug: Rimegepant
BHV-3000 (rimegepant) 75 mg (ODT)

Placebo Comparator: Arm 2: Placebo Comparator Drug Drug: Placebo
75mg matching placebo ODT




Primary Outcome Measures :
  1. Pain freedom of rimegepant 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)

  2. Freedom from the most bothersome symptom (MBS) of rimegepant 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 :
  1. To measure rimegepant compared to placebo on Pain Relief, at 2 hours post-dose, 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)

  2. Functional disability scale [ Time Frame: 2 hour post-dose ]
    Subjects self-report "normal" on the functional disability scale

  3. Rimegepant 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)

  4. Sustained freedom from most bothersome symptom from 2 to 24 hours , assessed by using the number of subjects that do not experience their most bothersome symptom through below time period. [ Time Frame: 2 to 24 hours post dose ]
    Most bothersome symptom

  5. To measure rimegepant compared to placebo on the probability of requiring rescue medication will be assessed 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

  6. Sustained ability to function at a normal level as measured by the Functional disability scale [ Time Frame: 2 to 24 hours post dose ]
    Subjects self-report "normal" on the functional disability scale

  7. Rimegepant 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)

  8. Rimegepant compared to placebo on pain freedom from most bothersome symptom from 2- 48 hours post dose. [ Time Frame: 2 to 48 hours post dose ]
    Most bothersome symptom

  9. Sustained ability to function at a normal level as measured by the Functional disability scale [ Time Frame: 2 to 48 hours post dose ]
    Subjects self-report "normal" on the functional disability scale

  10. Rimegepant compared to placebo by tabulating the number of subjects that report 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 ]
    Freedom from Photophobia

  11. Functional disability scale [ Time Frame: 90 minutes post dose ]
    Subjects self-report "normal" on the functional disability scale

  12. Rimegepant compared to placebo on sustained pain relief at 90 minutes, using the number of subjects that do not use any rescue medications and do not experience moderate to severe headache pain. [ Time Frame: 90 minutes post dose ]
    Pain Relief as measured by a 4 point numeric rating scale (None, Mild, Moderate, Severe)

  13. Rimegepant 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)

  14. Sustained freedom from most bothersome symptom at 90 minutes, assessed by using the number of subjects that do not experience their most bothersome symptom through below time period. [ Time Frame: 90 minutes post-dose ]
    Most bothersome symptom

  15. Rimegepant compared to placebo on sustained pain freedom 90 minutes post dose, will be measured using the number of subjects that do not experience any headache pain through the time period of interest. [ Time Frame: 90 minutes post-dose ]
    Sustained Pain Freedom as measured by a 4 point numeric rating scale

  16. Rimegepant 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 ]
    Freedom from Phonophobia

  17. Rimegepant compared to placebo on sustained pain freedom, from 2 to 48 hours, will be measured using the number of subjects that do not experience any headache pain through the time period of interest. [ Time Frame: 2 hours - 48 hours post-dose ]
    Sustained Pain Freedom as measured by a 4 point numeric rating scale (None, Mild, Moderate, Severe)

  18. To measure rimegepant compared to placebo on Pain Relief, at 60 minutes post-dose, that report a pain level of moderate or severe at baseline and then report a pain level of none or mild. [ Time Frame: 60 minutes post dose ]
    Sustained Pain Relief as measured by a 4 point numeric rating scale (None, Mild, Moderate, Severe)

  19. Functional disability scale [ Time Frame: 60 minutes post dose ]
    Subjects self-report "normal" on the functional disability scale

  20. Freedom from Nausea will 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

  21. To assess the number of subjects that are pain free at 2 hours post-dose and then have a headache of any severity (response of 1, 2 or 3 on the 4-point scale within 48 hours after administrations of study medication, rimegepant or placebo. [ Time Frame: 2 hours - 48 hours post-dose ]
    Pain relapse



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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 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:

  1. Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age
  2. Migraine attacks, on average, lasting about 4-72 hours if untreated
  3. Not more than 8 attacks of moderate to severe intensity per month within the last 3 months
  4. 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
  5. 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.
  6. Subjects 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 screening visit and the dose is not expected to change during the course of the study.
  7. Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria.

Exclusion Criteria:

  1. Subject with a history of HIV disease
  2. 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
  3. 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 being enrolled)
  4. Subject has a 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.
  5. 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
  6. The subject has a history of current or evidence of any significant and/ or unstable medical conditions (e.g., 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 subjects who have met DSM-V criteria [15] for any significant substance use disorder within the past 12 months from the date of the screening visit.
  8. Subjects are excluded if they have previously participated in any BHV-30000 (rimegepant) study within the last 2 years.
  9. Participation in any other investigational clinical trial while participating in this clinical 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): NCT03461757


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Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.

Responsible Party: Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03461757     History of Changes
Other Study ID Numbers: BHV3000-303
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018

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

Keywords provided by Biohaven Pharmaceuticals, Inc.:
Acute Migraine
phonophobia
photophobia
nausea

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