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

Phase 2

Completed

• Conditions: Migraine; Acute Treatment of Migraine
• Interventions: Drug: Rimegepant; Drug: Placebo; Drug: Sumatriptan

• Registration Number: NCT01430442
• Lead Sponsor: Pfizer

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

Study Timeline

• Study First Submitted: 2011-09-07
• Study First Submitted QC: 2011-09-07
• Study First Posted: 2011-09-08
• Study Start: 2011-10
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Disposition First Submitted: 2015-09-23
• Disposition First Submitted QC: 2015-09-23
• Disposition First Posted: 2015-10-12
• Results First Submitted: 2020-08-05
• Results First Submitted QC: 2020-08-19
• Results First Posted: 2020-09-03
• Status Verified: 2022-12
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1026

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment D: Rimegepant, 150 mg	Rimegepant	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.
Treatment A: Rimegepant, 10 mg	Placebo	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.
Treatment B: Rimegepant, 25 mg	Placebo	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.
Treatment C: Rimegepant, 75 mg	Rimegepant	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.
Treatment C: Rimegepant, 75 mg	Placebo	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.
Treatment D: Rimegepant, 150 mg	Placebo	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.
Treatment E: Rimegepant, 300 mg	Placebo	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.
Treatment F: Rimegepant, 600 mg	Placebo	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.
Treatment P: Rimegepant Placebo-Matching Capsules	Placebo	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.
Treatment G: Sumatriptan 100 mg	Placebo	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.
Treatment G: Sumatriptan 100 mg	Sumatriptan	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.
Treatment A: Rimegepant, 10 mg	Rimegepant	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.
Treatment B: Rimegepant, 25 mg	Rimegepant	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.
Treatment E: Rimegepant, 300 mg	Rimegepant	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.
Treatment F: Rimegepant, 600 mg	Rimegepant	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.

Primary Outcome Measures

Name	Time	Method
Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose	Baseline, 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

Name	Time	Method
Number of Participants With Total Migraine Freedom at 2 Hours Post Dose	Baseline, 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	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).	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	2 hours 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	2 hours 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.

Trial Locations

Locations (40)

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

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