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

Primary Purpose

Migraine, Acute Treatment of Migraine

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rimegepant
Placebo
Sumatriptan
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Arizona
  • Clinical Res. Advantage Inc/ Desert Clinical Research Llc
  • University Of California, San Francisco
  • California Medical Clinic For Headache
  • Encompass Clinical Research
  • Diablo Clinical Research, Inc.
  • Radiant Research, Inc.
  • Miami Research Associates
  • Renstar Medical Research
  • Compass Research, Llc
  • Broward Research Group
  • Comprehensive Clinical Development, Inc
  • Diamond Headache Clinic, Ltd.
  • Milford Emergency Associates, Inc.
  • Medvadis Research Corporation
  • Michigan Head Pain And Neurological Institute
  • Clinical Research Institute, Inc.
  • The Center For Pharmaceutical Research. Pc
  • Mercy Health Research
  • Clinvest/ A Division Of Banyan Group, Inc.
  • Regional Clinical Research Inc.
  • Central New York Clinical Research
  • Rochester Clinical Research, Inc.
  • Pharmquest
  • Wake Research Associates
  • Pmg Research Of Winston-Salem
  • Community Research
  • Cleveland Clinic
  • Thomas Jefferson University
  • Clinical Research Of Philadelphia, Llc
  • Omega Medical Research
  • Coastal Carolina Research Center, Inc.
  • Clinsearch, Llc
  • Premier Research Group Limited
  • Futuresearch Trials Of Neurology
  • R/D Clinical Research, Inc.
  • J. Lewis Research, Inc
  • J. Lewis Research, Inc
  • The Innovative Clinical Research Center
  • Tidewater Integrated Medical Research
  • Swedish Pain And Headache Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

Treatment A: Rimegepant, 10 mg

Treatment B: Rimegepant, 25 mg

Treatment C: Rimegepant, 75 mg

Treatment D: Rimegepant, 150 mg

Treatment E: Rimegepant, 300 mg

Treatment F: Rimegepant, 600 mg

Treatment P: Rimegepant Placebo-Matching Capsules

Treatment G: Sumatriptan 100 mg

Arm Description

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
September 7, 2011
Last Updated
February 27, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01430442
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 2011 (Actual)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Acute Treatment of Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1026 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment A: Rimegepant, 10 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment B: Rimegepant, 25 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment C: Rimegepant, 75 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment D: Rimegepant, 150 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment E: Rimegepant, 300 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment F: Rimegepant, 600 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment P: Rimegepant Placebo-Matching Capsules
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Treatment G: Sumatriptan 100 mg
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rimegepant
Intervention Description
Rimegepant capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Rimegepant placebo-matching capsules
Intervention Type
Drug
Intervention Name(s)
Sumatriptan
Other Intervention Name(s)
Imitrex®
Intervention Description
Rimegepant matching sumatriptan and Rimegepant matching placebo capsules
Primary Outcome Measure Information:
Title
Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants With Total Migraine Freedom at 2 Hours Post Dose
Description
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
Title
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuation Due to Adverse Events
Description
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).
Title
Number of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours Post Dose
Description
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
Title
Number of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours Post Dose
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Clinical Res. Advantage Inc/ Desert Clinical Research Llc
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
University Of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
California Medical Clinic For Headache
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Encompass Clinical Research
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Radiant Research, Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Compass Research, Llc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Broward Research Group
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
Comprehensive Clinical Development, Inc
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33716
Country
United States
Facility Name
Diamond Headache Clinic, Ltd.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60642
Country
United States
Facility Name
Milford Emergency Associates, Inc.
City
Milford
State/Province
Massachusetts
ZIP/Postal Code
01757
Country
United States
Facility Name
Medvadis Research Corporation
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472-3930
Country
United States
Facility Name
Michigan Head Pain And Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Clinical Research Institute, Inc.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
The Center For Pharmaceutical Research. Pc
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Mercy Health Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Clinvest/ A Division Of Banyan Group, Inc.
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Regional Clinical Research Inc.
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Central New York Clinical Research
City
Manlius
State/Province
New York
ZIP/Postal Code
13104
Country
United States
Facility Name
Rochester Clinical Research, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Pharmquest
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Pmg Research Of Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Community Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Clinical Research Of Philadelphia, Llc
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Coastal Carolina Research Center, Inc.
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Clinsearch, Llc
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Premier Research Group Limited
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Futuresearch Trials Of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
R/D Clinical Research, Inc.
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
J. Lewis Research, Inc
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J. Lewis Research, Inc
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
The Innovative Clinical Research Center
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
Facility Name
Tidewater Integrated Medical Research
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Swedish Pain And Headache Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23965396
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.
Results Reference
derived

Learn more about this trial

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

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