Clinical trial NCT01430442: Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine
Official title: Phase IIb: Double-Blind, Randomized, Placebo Controlled, Dose-ranging Trial of BMS-927711 for the Acute Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine
Acute Treatment of Migraine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-09-08
Enrollment: 1026
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose
timeFrame: Baseline, 2 hours post-dose
Secondary outcomes:
measure: Number of Participants With Total Migraine Freedom at 2 Hours Post Dose
timeFrame: Baseline, 2 hours post dose
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuation Due to Adverse Events
timeFrame: 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).
measure: Number of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours Post Dose
timeFrame: 2 hours to 24 hours post dose
measure: Number of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours Post Dose
timeFrame: 2 hours to 48 hours post dose
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Tempe
country: United States
facility: Clinical Res. Advantage Inc/ Desert Clinical Research Llc
state: Arizona
city: San Francisco
country: United States
facility: University Of California, San Francisco
state: California
city: Santa Monica
country: United States
facility: California Medical Clinic For Headache
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Denver
country: United States
facility: Radiant Research, Inc.
state: Colorado
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Compass Research, Llc
state: Florida
city: Pembroke Pines
country: United States
facility: Broward Research Group
state: Florida
city: Saint Petersburg
country: United States
facility: Comprehensive Clinical Development, Inc
state: Florida
city: Chicago
country: United States
facility: Diamond Headache Clinic, Ltd.
state: Illinois
city: Milford
country: United States
facility: Milford Emergency Associates, Inc.
state: Massachusetts
city: Watertown
country: United States
facility: Medvadis Research Corporation
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head Pain And Neurological Institute
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute, Inc.
state: Minnesota
city: Kansas City
country: United States
facility: The Center For Pharmaceutical Research. Pc
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Springfield
country: United States
facility: Clinvest/ A Division Of Banyan Group, Inc.
state: Missouri
city: Endwell
country: United States
facility: Regional Clinical Research Inc.
state: New York
city: Manlius
country: United States
facility: Central New York Clinical Research
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Greensboro
country: United States
facility: Pharmquest
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Pmg Research Of Winston-Salem
state: North Carolina
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Clinical Research Of Philadelphia, Llc
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center, Inc.
state: South Carolina
city: Chattanooga
country: United States
facility: Clinsearch, Llc
state: Tennessee
city: Austin
country: United States
facility: Premier Research Group Limited
state: Texas
city: Austin
country: United States
facility: Futuresearch Trials Of Neurology
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc
state: Utah
city: Alexandria
country: United States
facility: The Innovative Clinical Research Center
state: Virginia
city: Virginia Beach
country: United States
facility: Tidewater Integrated Medical Research
state: Virginia
city: Seattle
country: United States
facility: Swedish Pain And Headache Center
state: Washington
Study officials:
References:
citation: 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.