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.
Intervention Model: Parallel Versus Comparator + Placebo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,026
Rimegepant capsules
Rimegepant placebo-matching capsules
Rimegepant matching sumatriptan and Rimegepant matching placebo capsules
Number of Pain Free Participants (Pain Freedom) at 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.
Time frame: Baseline, 2 hours post-dose
Number of Participants With Total Migraine Freedom at 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.
Time frame: Baseline, 2 hours post dose
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuation Due to Adverse Events
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.
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).
Number of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours Post Dose
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Mayo Clinic Arizona
Scottsdale, Arizona, United States
Clinical Res. Advantage Inc/ Desert Clinical Research Llc
Tempe, Arizona, United States
University Of California, San Francisco
San Francisco, California, United States
California Medical Clinic For Headache
Santa Monica, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Radiant Research, Inc.
Denver, Colorado, United States
Miami Research Associates
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Compass Research, Llc
Orlando, Florida, United States
...and 31 more locations
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.
Time frame: 2 hours to 24 hours post dose
Number of Participants Achieving Sustained Pain Freedom From 2 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.
Time frame: 2 hours to 48 hours post dose