Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine

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.
 
ClinicalTrials.gov Identifier: NCT01430442
Recruitment Status : Completed
First Posted : September 8, 2011
Results First Posted : September 3, 2020
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

Brief Summary:
The primary purpose of this study is to evaluate the efficacy of rimegepant (BMS-927711) compared with placebo in the acute treatment of migraine as measured by Pain Freedom (headache pain intensity level reported as "no pain") at 2 hours post dose using a four point numeric rating scale (no pain, mild pain, moderate pain, severe pain) while identifying an optimal dose to support the Phase 3 clinical trials.

Condition or disease Intervention/treatment Phase
Migraine Acute Treatment of Migraine Drug: Rimegepant Drug: Placebo Drug: Sumatriptan Phase 2

Detailed Description:
Intervention Model: Parallel Versus Comparator + Placebo

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1026 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase IIb: Double-Blind, Randomized, Placebo Controlled, Dose-ranging Trial of BMS-927711 for the Acute Treatment of Migraine
Actual Study Start Date : October 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine
Drug Information available for: Sumatriptan

Arm Intervention/treatment
Experimental: Treatment A: Rimegepant, 10 mg
Participants received a single dose (one capsule) of rimegepant 10 milligram (mg) orally and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
Drug: Rimegepant
Rimegepant capsules

Drug: Placebo
Rimegepant placebo-matching capsules

Experimental: Treatment B: Rimegepant, 25 mg
Participants received a single dose (one capsule) of rimegepant 25 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
Drug: Rimegepant
Rimegepant capsules

Drug: Placebo
Rimegepant placebo-matching capsules

Experimental: Treatment C: Rimegepant, 75 mg
Participants received a single dose (one capsule) of rimegepant 75 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
Drug: Rimegepant
Rimegepant capsules

Drug: Placebo
Rimegepant placebo-matching capsules

Experimental: Treatment D: Rimegepant, 150 mg
Participants received a single dose (one capsule) of rimegepant 150 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
Drug: Rimegepant
Rimegepant capsules

Drug: Placebo
Rimegepant placebo-matching capsules

Experimental: Treatment E: Rimegepant, 300 mg
Participants received a single dose (two 150 mg capsules) of rimegepant 300 mg orally; and two rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
Drug: Rimegepant
Rimegepant capsules

Drug: Placebo
Rimegepant placebo-matching capsules

Experimental: Treatment F: Rimegepant, 600 mg
Participants received a single dose (four capsules of 150 mg each) of rimegepant 600 mg orally; anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
Drug: Rimegepant
Rimegepant capsules

Drug: Placebo
Rimegepant placebo-matching capsules

Placebo Comparator: Treatment P: Rimegepant Placebo-Matching Capsules
Participants received a single dose (4 capsules) of rimegepant placebo-matching capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity.
Drug: Placebo
Rimegepant placebo-matching capsules

Active Comparator: Treatment G: Sumatriptan 100 mg
Participants received a single dose (one capsule) of rimegepant-matching sumatriptan 100 mg orally and three rimegepant matching placebo capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity.
Drug: Placebo
Rimegepant placebo-matching capsules

Drug: Sumatriptan
Rimegepant matching sumatriptan and Rimegepant matching placebo capsules
Other Name: Imitrex®




Primary Outcome Measures :
  1. Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose [ Time Frame: Baseline, 2 hours post-dose ]
    Pain freedom was defined as participants reporting a value of "none" on the four-point numeric rating scale (none=0, mild =1, moderate =2, severe =3) from baseline. Participants with baseline moderate pain or severe pain were included in the analysis.


Secondary Outcome Measures :
  1. Number of Participants With Total Migraine Freedom at 2 Hours Post Dose [ Time Frame: Baseline, 2 hours post dose ]
    Total migraine freedom is defined as complete absence of migraine symptoms. A participant was positive for total migraine freedom at a particular time point if he/she reports the absence of: pain, nausea, photophobia, and phonophobia. This corresponds to reporting "none" on each of the four-point numeric rating scale (none =0, mild =1, moderate =2, severe =3) from baseline associated with these symptoms. Participants with baseline moderate pain or severe pain were included in the analysis.

  2. Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuation Due to Adverse Events [ Time Frame: AEs: from first dose to end of treatment visit (up to 7 weeks); SAE: from signing of informed consent to 30 days after the last dose (up to 11 weeks). ]
    An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition, unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or suspected transmission of an infectious agent, or encompassed any other clinically significant event that could jeopardize the subject or require medical or surgical intervention to prevent one of the aforementioned outcomes.

  3. Number of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours Post Dose [ Time Frame: 2 hours to 24 hours post dose ]
    Participants were considered to have sustained pain freedom if all of their reported pain readings in the interval are "none" on the four point numeric rating scale (no pain=0, mild pain=1, moderate pain=2, severe pain=3). The intervals are inclusive of the endpoints. Sustained pain freedom was analyzed with a Cochran Mantel Haenszel (CMH) test for general association that compares the ED90 to placebo, and controls for baseline pain severity.

  4. Number of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours Post Dose [ Time Frame: 2 hours to 48 hours post dose ]
    Participants were considered to have sustained pain freedom if all of their reported pain readings in the interval are "none" on the four point numeric rating scale (no pain=0, mild pain=1, moderate pain=2, severe pain=3). The intervals are inclusive of the endpoints. Sustained pain freedom was analyzed with a CMH test for general association that compares the ED90 to placebo, and controls for baseline pain severity.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Patient with at least 1-year history of migraines (with or without aura) including the following:

    • Migraine attacks more than 1 year with age of onset prior to 50 years of age
    • Migraine attacks, on average, last about 4 - 72 hours if untreated
    • No more than 8 attacks of moderate to severe intensity per month within last 3 months
    • Patient must be able to distinguish migraine attacks from tension/cluster attacks and must have consistent migraine headaches of at least 2 migraine headaches attacks of moderate to severe intensity in each of the last 3 months
    • Less than 15 days of headache (migraine or non-migraine) per month in each of 3 months prior to screening
  • Male and female ≥ 18 years and ≤ age 65
  • No clinically significant abnormality identified on the medical or laboratory evaluation

Key Exclusion Criteria:

  • Patient has a history of basilar migraine or hemiplegic migraine
  • Patient does not receive migraine relief from triptan migraine treatment
  • Medications that may alter the pH of the stomach (acid reducing agents), such as H-2 antagonists, Proton Pump inhibitors (PPI), antacids
  • History of ergotamine or triptan intake greater than/equal 10 days per month on a regular basis for greater than 3 months
  • History of non-narcotic analgesic intake on greater then/equal 15 days per month for greater than/equal 3 months

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): NCT01430442


Locations
Show Show 41 study locations
Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01430442    
Other Study ID Numbers: CN170-003
First Posted: September 8, 2011    Key Record Dates
Results First Posted: September 3, 2020
Last Update Posted: September 3, 2020
Last Verified: August 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sumatriptan
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs