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Safety and Efficacy in Adult Subjects With Acute Migraines

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ClinicalTrials.gov Identifier: NCT03237845
Recruitment Status : Completed
First Posted : August 3, 2017
Results First Posted : December 23, 2020
Last Update Posted : February 16, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment Phase
Migraine, With or Without Aura Drug: Rimegepant Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1499 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double-blind to Sponsor, Investigator and Participant
Primary Purpose: Treatment
Official Title: BHV3000-302 : Phase 3: Double-Blind, Randomized, Placebo-Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) for the Acute Treatment of Migraine
Actual Study Start Date : July 27, 2017
Actual Primary Completion Date : January 25, 2018
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Rimegepant 75 mg
Participants were administered a single oral dose of 75 mg of rimegepant tablet on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
 Drug: Rimegepant
75 mg tablet QD
Other Name: BHV-3000
Placebo Comparator: Placebo
Participants were administered a single oral dose of matching placebo tablet for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
 Drug: Placebo
Placebo tablet to match rimegepant dose QD


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Freedom From Pain at 2 Hours Post-dose [ Time Frame: 2 Hours post-dose ]
    Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic diary (eDiary). Pain freedom was defined as pain level of none.

  2. Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose [ Time Frame: 2 Hours ]
    MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at onset that was absent post-dose.


Secondary Outcome Measures :
  1. Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose [ Time Frame: 2 hours post-dose ]
    Photophobia (sensitivity to light) status was measured as absent or present in the eDiary. Freedom from photophobia was defined as photophobia absent.

  2. Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose [ Time Frame: 2 hours post-dose ]
    Phonophobia (sensitivity to sound) status was measured as absent or present in the eDiary. Freedom from phonophobia was defined as phonophobia absent.

  3. Percentage of Participants With Pain Relief at 2 Hours Post-dose [ Time Frame: 2 hours post-dose ]
    Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relief was defined as pain level of none or mild.

  4. Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose [ Time Frame: 2 hours post-dose ]
    Nausea status was measured as absent or present in the eDiary. Freedom from nausea was defined as nausea absent.

  5. Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose [ Time Frame: 24 hours post-dose ]
    Participants who did not experience relief of their migraine headache at the end of 2 hours after dosing with study medication (and after the 2-hour assessments had been completed on the eDiary) were permitted to use the following rescue medications: aspirin, ibuprofen, acetaminophen up to 1000 mg/day (this includes Excedrin Migraine), naproxen (or any other type of nonsteroidal anti-inflammatory drug), antiemetics (e.g., metoclopramide or promethazine), or baclofen. The participant's use of rescue medication was recorded by the participant in a paper diary.

  6. Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose [ Time Frame: From 2 hours up to 24 hours post-dose ]
    Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom was defined as pain level of none at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.

  7. Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose [ Time Frame: From 2 hours up to 24 hours post-dose ]
    Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.

  8. Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose [ Time Frame: From 2 hours up to 48 hours post-dose ]
    Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom was defined as pain level of none at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.

  9. Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose [ Time Frame: From 2 hours up to 48 hours post-dose ]
    Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.

  10. Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose [ Time Frame: From 2 hours up to 48 hours post-dose ]
    Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relapse was defined as pain level of mild, moderate, or severe after 2 hours up to 48 hours for the participants who were pain-free at 2 hours post-dose.

  11. Percentage of Participants With Freedom From Functional Disability at 2 Hours Post-dose [ Time Frame: 2 hours post-dose ]
    Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Freedom from functional disability was defined as normal function.


Eligibility Criteria
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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

Key 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.

Key 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, hepatitisB 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 ofthe 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 thepast 12 months from the date of the screening visit.
Contacts and Locations
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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): NCT03237845


Locations
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Sponsors and Collaborators
Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] January 23, 2018
Statistical Analysis Plan  [PDF] June 20, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03237845    
Other Study ID Numbers: BHV3000-302
First Posted: August 3, 2017    Key Record Dates
Results First Posted: December 23, 2020
Last Update Posted: February 16, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases