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Completed

NCT Number: NCT01430442

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

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.

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Key information

Conditions

Migraine Acute Treatment of Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic Arizona, Scottsdale, Arizona, United States

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About this study

Intervention Model: Parallel Versus Comparator + Placebo

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rimegepant

Drug

Rimegepant capsules

Placebo

Drug

Rimegepant placebo-matching capsules

Sumatriptan

Drug

Rimegepant matching sumatriptan and Rimegepant matching placebo capsules

Other names: Imitrex®

Primary outcomes

  1. Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose

    Time frame: 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 outcomes

  1. Number of Participants With Total Migraine Freedom at 2 Hours Post Dose

    Time frame: 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.

  2. Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuation Due to Adverse Events

    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).

    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.

  3. Number of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours Post Dose

    Time frame: 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.

  4. Number of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours Post Dose

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 8, 2011
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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