A multi-centre, randomized, double-blind, parallel group, active and placebo controlled, Proof of Concept study in patients with acute migraine to assess the efficacy, safety and tolerability of single oral doses of BGG492

INTERVENTION: Product Name: BGG492 Product Code: BGG492 Pharmaceutical Form: Capsule, hard Current Sponsor code: BGG492 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: SUMATRIPTAN Pharmaceutical Form: Capsule, hard INN or Proposed INN: sumatriptan Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use CONDITION: Acute migraine Migraña Aguda PRIMARY OUTCOME: Main Objective: ?To assess the efficacy of a single dose of BGG492 vs. placebo in patients with acute migraine using the Migraine Patient Diary; ; ?To evaluate the safety and tolerability of single oral doses of 250 mg BGG492 in migraine patients Primary end point(s): Efficacy assessments; Migraine Patient Diary: Day 1: pre‐dose, 15, 30, 45, 60 and 90 min and 2, 3, 4 and 24 h after medication.; ; Safety and tolerability assessments; ? Vital signs and body measurements; ? Body height: Screening; ? Body weight: Screening, Day 1, Study completion; ? Body temperature: Screening, Day 1, Study completion; ? Blood pressure, pulse rate: Screening, Day 1, Study completion; (Note that all measurements are sitting and after 3 minutes standing); ? ECG evaluation: Screening, Day 1, Study completion; ? Hematology; Blood chemistry; Urinalysis: Screening, Day 1, Study completion; ? Adverse events: from time of first administration of study drug until Study Completion. Adverse events occurring before starting study treatment but after signing the informed consent form are recorded on the Medical History/Current Medical Conditions Case Report Form.; ? Serious adverse events: from time of consent until 4 weeks after Study Completion; ? Concomitant medications/Significant non‐drug therapies: Refer to entry criteria (Section 5.1) and Concomitant medication (Section 6.6.5) for details of recording requirements for allowed and restricted medications during the study. Secondary Objective: ?To evaluate the improvement in pain score, sustained response rate, pain‐free rate, and sustained pain‐free rate using the Migraine Patient Diary; ; ?To determine the pharmacokinetic profile of BGG492 in patients with acute migraine and to explore the PK/PD relationship INCLUSION CRITERIA: 1.Healthy male and female subjects age 18 to 60 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. 2.Patients must have a diagnosis of migraine and have experienced episodes of migraine, with or without aura (International Headache Society categories 1.1 and 1.2) for at least one year prior to study entry, and should experience moderate or severe migraine. 3.Patients are required to be able to distinguish migraine from other types of headache. 4.Patients must have more than 4 but not more than 15 migraine episodes per month for each of the six months prior to the study. 5.Patients must have used triptans in their past medical history. 6.Patients must have had migraine onset before 50 years of age. 7.At Screening, and Baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be ass