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

Migraine Clinical Trial

Official title:

Phase IIb: Double-Blind, Randomized, Placebo Controlled, Dose-ranging Trial of BMS-927711 for the Acute Treatment of Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01430442
• Other study ID #: CN170-003
• Status: Completed
• Phase: Phase 2
• Start date: October 2011
• Est. completion date: May 2012

Study information

• Verified date: December 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Intervention Model: Parallel Versus Comparator + Placebo

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1026
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Treatment of Migraine
• Migraine
• Migraine Disorders

Intervention

Drug:
• Rimegepant
Rimegepant capsules
• Placebo
Rimegepant placebo-matching capsules
• Sumatriptan
Rimegepant matching sumatriptan and Rimegepant matching placebo capsules

Locations

Country	Name	City	State
United States	The Innovative Clinical Research Center	Alexandria	Virginia
United States	Michigan Head Pain And Neurological Institute	Ann Arbor	Michigan
United States	Futuresearch Trials Of Neurology	Austin	Texas
United States	Premier Research Group Limited	Austin	Texas
United States	Clinsearch, Llc	Chattanooga	Tennessee
United States	Diamond Headache Clinic, Ltd.	Chicago	Illinois
United States	Community Research	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Radiant Research, Inc.	Denver	Colorado
United States	Regional Clinical Research Inc.	Endwell	New York
United States	Pharmquest	Greensboro	North Carolina
United States	The Center For Pharmaceutical Research. Pc	Kansas City	Missouri
United States	R/D Clinical Research, Inc.	Lake Jackson	Texas
United States	Central New York Clinical Research	Manlius	New York
United States	Miami Research Associates	Miami	Florida
United States	Milford Emergency Associates, Inc.	Milford	Massachusetts
United States	Clinical Research Institute, Inc.	Minneapolis	Minnesota
United States	Coastal Carolina Research Center, Inc.	Mount Pleasant	South Carolina
United States	Renstar Medical Research	Ocala	Florida
United States	Compass Research, Llc	Orlando	Florida
United States	Broward Research Group	Pembroke Pines	Florida
United States	Clinical Research Of Philadelphia, Llc	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Wake Research Associates	Raleigh	North Carolina
United States	Rochester Clinical Research, Inc.	Rochester	New York
United States	Mercy Health Research	Saint Louis	Missouri
United States	Comprehensive Clinical Development, Inc	Saint Petersburg	Florida
United States	J. Lewis Research, Inc	Salt Lake City	Utah
United States	J. Lewis Research, Inc	Salt Lake City	Utah
United States	University Of California, San Francisco	San Francisco	California
United States	California Medical Clinic For Headache	Santa Monica	California
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	Swedish Pain And Headache Center	Seattle	Washington
United States	Encompass Clinical Research	Spring Valley	California
United States	Clinvest/ A Division Of Banyan Group, Inc.	Springfield	Missouri
United States	Clinical Res. Advantage Inc/ Desert Clinical Research Llc	Tempe	Arizona
United States	Tidewater Integrated Medical Research	Virginia Beach	Virginia
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Omega Medical Research	Warwick	Rhode Island
United States	Medvadis Research Corporation	Watertown	Massachusetts
United States	Pmg Research Of Winston-Salem	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline, 2 hours post dose
Secondary	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.	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).
Secondary	Number of Participants Achieving Sustained Pain Freedom From 2 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.	2 hours to 24 hours post dose
Secondary	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.	2 hours to 48 hours post dose