Conditions: Migraine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 420
Healthy volunteers: no

Brief summary:
The purpose of this study is to investigate the efficacy and safety of an MK 0974 for migraine headache and to identify an appropriate dose range for further study.

Detailed description:

Arms:
arm 1: Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache. arm 2: MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. arm 3: MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. arm 4: MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. arm 5: MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. arm 6: MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. arm 7: MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. arm 8: MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. arm 9: Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.

Interventions: intervention 1: Comparator: Placebo intervention 2: MK0974 intervention 3: MK0974 intervention 4: MK0974 intervention 5: MK0974 intervention 6: MK0974 intervention 7: MK0974 intervention 8: MK0974 intervention 9: Rizatriptan
Intervention descriptions: intervention 1: Placebo to match assigned treatment arm; one orally-administered dose intervention 2: MK0974 25 mg; one orally-administered dose intervention 3: MK0974 50 mg; one orally-administered dose intervention 4: MK0974 100 mg; one orally-administered dose intervention 5: MK0974 200 mg; one orally-administered dose intervention 6: MK0974 300 mg; one orally-administered dose intervention 7: MK0974 400 mg; one orally-administered dose intervention 8: MK0974 600 mg; one orally-administered dose intervention 9: Rizatriptan 10 mg; one orally-administered dose

Protocol document: