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

INTERVENTION: Product Code: BI 44370 Pharmaceutical Form: Tablet Current Sponsor code: BI 44370 TA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Code: BI 44370 Pharmaceutical Form: Tablet Current Sponsor code: BI 44370 TA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Relpax Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: ELETRIPTAN CAS Number: 143322581 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use CONDITION: migraine headache with and without aura ; MedDRA version: 9.1 Level: LLT Classification code 10027602 Term: Migraine headache PRIMARY OUTCOME: Main Objective: The primary objective is to achieve a pain free response, defined as reduction of severe or moderate headache to no headache, 2 hours after dosing with BI 44370 TA in comparison with placebo, in patients with an acute migraine attack of moderate or severe intensity. Primary end point(s): The primary endpoint is a pain free response, defined as reduction of severe or moderate headache to no headache, 2 hours after dosing. Secondary Objective: Secondary objectives are to assess the safety, tolerability, and efficacy of three doses of BI 44370 TA (50 mg, 200 mg, and 400 mg) in treatment of an acute migraine attack of moderate or severe intensity compared to placebo and to an active comparator (eletriptan 40 mg). INCLUSION CRITERIA: ‐ Adult male and female migraine patients (age more than 18 and less than 65 years) with or without aura. ‐ Established migraine diagnosis for = 1 year. ‐ Age at migraine onset = 50 years. ‐ Well documented history of migraine with headache of moderate to severe intensity, with attack duration of at least 6 hours and migraine frequency of 2‐8 times / month, during preceding 3 months (but not more than 12 days with migraine / month). ‐ Other forms of headache are permitted if they on average occur on not more than 10 days / month and if the patient is able to differentiate migraine headache from other forms of headache. ‐ Patients in general good health based on screening assessment. ‐ Patient has provided written informed consent in accordance with ICH‐GCP and local legislation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range