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

CompletedPhase 2

Sponsor: Pfizer

Conditions: Migraine, Acute Treatment of Migraine

Interventions: Rimegepant, Placebo, Sumatriptan

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (41)

Scottsdale, Arizona, United States
Tempe, Arizona, United States
San Francisco, California, United States
Santa Monica, California, United States
Spring Valley, California, United States
Walnut Creek, California, United States
Denver, Colorado, United States
Miami, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Pembroke Pines, Florida, United States
St. Petersburg, Florida, United States
Chicago, Illinois, United States
Milford, Massachusetts, United States
Watertown, Massachusetts, United States
Ann Arbor, Michigan, United States
Minneapolis, Minnesota, United States
Kansas City, Missouri, United States
Springfield, Missouri, United States
St Louis, Missouri, United States
Endwell, New York, United States
Manlius, New York, United States
Rochester, New York, United States
Greensboro, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
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