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

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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.

Tracking Information
First Submitted Date  ICMJE September 7, 2011
First Posted Date  ICMJE September 8, 2011
Results First Submitted Date  ICMJE August 5, 2020
Results First Posted Date  ICMJE September 3, 2020
Last Update Posted Date September 3, 2020
Actual Study Start Date  ICMJE October 2011
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2011)
Pain Freedom (from migraine pain) [ Time Frame: 2 hours post-dose ]
This variable will be set to "yes" if headache pain intensity level is reported as "no pain" on the four point intensity scale.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2011)
  • Total migraine freedom (pain freedom, coupled with no symptoms of phonophobia, photophobia, or nausea) [ Time Frame: At 2 hours post dose ]
  • Frequency and severity of adverse events [ Time Frame: During Double-blind treatment phase (approximately 11 weeks) ]
  • Sustained pain freedom [ Time Frame: from 2 to 24 hours post dose ]
  • Sustained pain freedom [ Time Frame: from 2 to 48 hours post dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine
Official Title  ICMJE Phase IIb: Double-Blind, Randomized, Placebo Controlled, Dose-ranging Trial of BMS-927711 for the Acute Treatment of Migraine
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.
Detailed Description Intervention Model: Parallel Versus Comparator + Placebo
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Migraine
  • Acute Treatment of Migraine
Intervention  ICMJE
  • Drug: Rimegepant
    Rimegepant capsules
  • Drug: Placebo
    Rimegepant placebo-matching capsules
  • Drug: Sumatriptan
    Rimegepant matching sumatriptan and Rimegepant matching placebo capsules
    Other Name: Imitrex®
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Rimegepant
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Rimegepant
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Rimegepant
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Rimegepant
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Rimegepant
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Rimegepant
    • Drug: Placebo
  • 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.
    Intervention: Drug: Placebo
  • 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.
    Interventions:
    • Drug: Placebo
    • Drug: Sumatriptan
Publications * Marcus R, Goadsby PJ, Dodick D, Stock D, Manos G, Fischer TZ. BMS-927711 for the acute treatment of migraine: a double-blind, randomized, placebo controlled, dose-ranging trial. Cephalalgia. 2014 Feb;34(2):114-25. doi: 10.1177/0333102413500727. Epub 2013 Aug 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2020)
1026
Original Estimated Enrollment  ICMJE
 (submitted: September 7, 2011)
720
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01430442
Other Study ID Numbers  ICMJE CN170-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biohaven Pharmaceuticals, Inc.
Study Sponsor  ICMJE Biohaven Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Biohaven Pharmaceuticals, Inc.
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP