A Randomised, Double-blind, Placebo- and Active Comparator-controlled, Five Parallel Groups Study to Investigate the Efficacy and Safety of BI 44370 TA (50 mg, 200 mg, and 400 mg) Administered Orally Once During an Acute Migraine Attack of Moderate or Severe Intensity

简要总结

主要结局

次要结局

• Intensity of headache at the time of intake of study medication, and 0.5, 1, 1.5, 2, 24 and 48 hours after dosing(up to 48 h)
• Pain relief, defined as reduction of severe or moderate headache to mild or no headache, 0.5, 1, 1.5, 2, 24 and 48 hours after dosing(up to 48 h)
• Sustained pain relief response, defined as reduction of severe or moderate headache to mild or no headache 2 hours after dosing and no worsening up to 24 and 48 hours after dosing(up to 48 h)
• Relief of associated migraine symptoms (nausea, vomiting, photophobia, phonophobia) 0.5, 1, 1.5, 2, 24 and 48 hours after dosing(up to 48 h)
• Pain-free response 0.5, 1, 1.5, 24 and 48 hours after dosing(up to 48 h)
• Sustained pain-free response, defined as reduction of severe or moderate headache to no headache 2 hours after dosing and remaining pain-free up to 24 and 48 hours after dosing(up to 48 h)
• Global evaluation of medication by the patient evaluated 48 h after study drug intake(up to 48 h)
• Time to meaningful relief, defined by the patient as occurring when relief of pain and associated symptoms becomes meaningful, up to 2 h after dosing(up to 2 h)
• Incidences of adverse events(up to 7 days)
• Time to and use of rescue medication within 24 and 48 hours(up to 48 h)
• Changes from baseline in vital sign parameters(up to 7 days)
• Withdrawals due to adverse events(up to 7 days)
• Functional disability assessed by the patient measured at the time of intake of study medication, and 0.5, 1, 1.5, 2, 24 and 48 hours post dosing(up to 48 h)
• Recurrence / relapse of headache during time-intervals of 2-24 and 2-48 hours post dosing(up to 48 h)
• Changes from baseline in safety laboratory parameters(up to 7 days)