Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine
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.
Intervention Model: Parallel Versus Comparator + Placebo
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