Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine
Phase IIb: Double-Blind, Randomized, Placebo Controlled, Dose-ranging Trial of BMS-927711 for the Acute Treatment of Migraine
1 other identifier
interventional
1,026
1 country
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2011
Shorter than P25 for phase_2
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2011
CompletedFirst Posted
Study publicly available on registry
September 8, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
September 3, 2020
CompletedFebruary 28, 2023
December 1, 2022
7 months
September 7, 2011
August 5, 2020
February 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline, 2 hours post-dose
Secondary Outcomes (4)
Number of Participants With Total Migraine Freedom at 2 Hours Post Dose
Baseline, 2 hours post dose
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuation Due to Adverse Events
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
2 hours to 24 hours post dose
Number of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours Post Dose
2 hours to 48 hours post dose
Study Arms (8)
Treatment A: Rimegepant, 10 mg
EXPERIMENTALParticipants 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.
Treatment B: Rimegepant, 25 mg
EXPERIMENTALParticipants 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.
Treatment C: Rimegepant, 75 mg
EXPERIMENTALParticipants 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.
Treatment D: Rimegepant, 150 mg
EXPERIMENTALParticipants 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.
Treatment E: Rimegepant, 300 mg
EXPERIMENTALParticipants 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.
Treatment F: Rimegepant, 600 mg
EXPERIMENTALParticipants 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.
Treatment P: Rimegepant Placebo-Matching Capsules
PLACEBO COMPARATORParticipants 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.
Treatment G: Sumatriptan 100 mg
ACTIVE COMPARATORParticipants 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
Rimegepant capsules
Rimegepant placebo-matching capsules
Rimegepant matching sumatriptan and Rimegepant matching placebo capsules
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (41)
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
Clinical Res. Advantage Inc/ Desert Clinical Research Llc
Tempe, Arizona, 85282, United States
University Of California, San Francisco
San Francisco, California, 94115, United States
California Medical Clinic For Headache
Santa Monica, California, 90404, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Radiant Research, Inc.
Denver, Colorado, 80239, United States
Miami Research Associates
Miami, Florida, 33143, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Compass Research, Llc
Orlando, Florida, 32806, United States
Broward Research Group
Pembroke Pines, Florida, 33026, United States
Comprehensive Clinical Development, Inc
St. Petersburg, Florida, 33716, United States
Diamond Headache Clinic, Ltd.
Chicago, Illinois, 60642, United States
Milford Emergency Associates, Inc.
Milford, Massachusetts, 01757, United States
Medvadis Research Corporation
Watertown, Massachusetts, 02472-3930, United States
Michigan Head Pain And Neurological Institute
Ann Arbor, Michigan, 48104, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, 55402, United States
The Center For Pharmaceutical Research. Pc
Kansas City, Missouri, 64114, United States
Clinvest/ A Division Of Banyan Group, Inc.
Springfield, Missouri, 65807, United States
Mercy Health Research
St Louis, Missouri, 63141, United States
Regional Clinical Research Inc.
Endwell, New York, 13760, United States
Central New York Clinical Research
Manlius, New York, 13104, United States
Rochester Clinical Research, Inc.
Rochester, New York, 14609, United States
Pharmquest
Greensboro, North Carolina, 27408, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Pmg Research Of Winston-Salem
Winston-Salem, North Carolina, 27103, United States
Community Research
Cincinnati, Ohio, 45227, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Clinical Research Of Philadelphia, Llc
Philadelphia, Pennsylvania, 19114, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Coastal Carolina Research Center, Inc.
Mt. Pleasant, South Carolina, 29464, United States
Clinsearch, Llc
Chattanooga, Tennessee, 37421, United States
Premier Research Group Limited
Austin, Texas, 78705, United States
Futuresearch Trials Of Neurology
Austin, Texas, 78731, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566, United States
J. Lewis Research, Inc
Salt Lake City, Utah, 84109, United States
J. Lewis Research, Inc
Salt Lake City, Utah, 84121, United States
The Innovative Clinical Research Center
Alexandria, Virginia, 22304, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23454, United States
Swedish Pain And Headache Center
Seattle, Washington, 98104, United States
Related Publications (1)
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.
PMID: 23965396DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Biohaven Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2011
First Posted
September 8, 2011
Study Start
October 1, 2011
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
February 28, 2023
Results First Posted
September 3, 2020
Record last verified: 2022-12