Conditions: Migraine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1068
Healthy volunteers: no

Brief summary:
The purpose of this study is to investigate the safety and tolerability of telcagepant (MK-0974) in the long-term treatment of acute migraine in adult participants. The primary hypothesis of this study is that telcagepant is well tolerated in the long-term treatment of acute migraine in adult participants.

Detailed description:

Arms:
arm 1: Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months. arm 2: Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.

Interventions: intervention 1: Telcagepant 300 mg soft gel capsules intervention 2: Telcagepant 280 mg tablets intervention 3: Rizatriptan 10 mg tablets intervention 4: Placebo to telcagepant capsules intervention 5: Placebo to telcagepant tablets intervention 6: Placebo to rizatriptan tablets
Intervention descriptions: intervention 1: One capsule taken orally at onset of migraine intervention 2: One tablet taken orally at onset of migraine intervention 3: One tablet taken orally at onset of migraine intervention 4: One capsule taken orally at onset of migraine intervention 5: One tablet taken orally at onset of migraine intervention 6: One tablet taken orally at onset of migraine

Protocol document: