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

Phase IIb: Double-Blind, Randomized, Placebo Controlled, Dose-ranging Trial of 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