Dose Ranging Study of a Drug for the Treatment of Acute Migraine

• Total migraine freedom (pain freedom, coupled with no symptoms of phonophobia, photophobia, or nausea) [ Time Frame: At 2 hours post dose ] [ Designated as safety issue: No ]
• Frequency and severity of adverse events [ Time Frame: During Double-blind treatment phase (approximately 11 weeks) ] [ Designated as safety issue: Yes ]
• Sustained pain freedom [ Time Frame: from 2 to 24 hours post dose ] [ Designated as safety issue: No ]
• Sustained pain freedom [ Time Frame: from 2 to 48 hours post dose ] [ Designated as safety issue: No ]

The purpose of this study is the exploration of a wide range of BMS-927711 doses that will reveal at least one dose that is safe and clinically superior to placebo in the treatment of acute migraine.

Intervention Model: Parallel Versus Comparator + Placebo

• Drug: Placebo matching BMS-927711
  Capsule, Oral, 0mg, One time, One dose
• Drug: BMS-927711
  Capsule, Oral, 10mg, One time, One dose
• Drug: BMS-927711
  Capsule, Oral, 25mg, One time, One dose
• Drug: BMS-927711
  Capsule, Oral, 75mg, One time, One dose
• Drug: BMS-927711
  Capsule, Oral, 150mg, One time, One dose
• Drug: BMS-927711
  Capsule, Oral, 300mg, One time, One dose
• Drug: BMS-927711
  Capsule, Oral, 600mg, One time, One dose
• Drug: Sumatriptan
  Capsule, Oral, 100mg, One time, One dose
  Other Name: Imitrex®

• Placebo Comparator: Arm 1: Placebo matching BMS-927711
  Intervention: Drug: Placebo matching BMS-927711
• Experimental: Arm 2: BMS-927711 and Placebo matching BMS-927711
  Interventions:

  • Drug: Placebo matching BMS-927711
  • Drug: BMS-927711
• Experimental: Arm 3: BMS-927711 and Placebo matching BMS-927711
  Interventions:

  • Drug: Placebo matching BMS-927711
  • Drug: BMS-927711
• Experimental: Arm 4: BMS-927711 and Placebo matching BMS-927711
  Interventions:

  • Drug: Placebo matching BMS-927711
  • Drug: BMS-927711
• Experimental: Arm 5: BMS-927711 and Placebo matching BMS-927711
  Interventions:

  • Drug: Placebo matching BMS-927711
  • Drug: BMS-927711
• Experimental: Arm 6: BMS-927711 and Placebo matching BMS-927711
  Interventions:

  • Drug: Placebo matching BMS-927711
  • Drug: BMS-927711
• Experimental: Arm 7: BMS-927711 and Placebo matching BMS-927711
  Interventions:

  • Drug: Placebo matching BMS-927711
  • Drug: BMS-927711
• Active Comparator: Arm 8: Sumatriptan and Placebo matching BMS-927711
  Interventions:

  • Drug: Placebo matching BMS-927711
  • Drug: Sumatriptan

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 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 severe to moderate 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

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