Clinical trial NCT00442936
Conditions: Migraine
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-02-15; Completion date: 2007-10-02
Enrollment: 1380 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the efficacy and safety of telcagepant (MK-0974) compared to an approved medication for acute migraine. This study was conducted as a "triple-dummy" design; for each dose of study drug, participants each received 3 forms of study drug (2 capsules of active and/or placebo and 1 tablet of active and/or placebo) and were instructed to take one of each form of study drug at dosing time.

The primary hypotheses of this study are that telcagepant is superior to placebo in Pain Freedom at 2 Hours Post-Dose, Pain Relief at 2 Hours Post-Dose, Absence of Photophobia at 2 Hours Post-Dose, Absence of Phonophobia at 2 Hours Post-Dose and Absence of Nausea at 2 Hours Post-Dose.

Detailed description:

Arms: arm 1: Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication. arm 2: Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication. arm 3: Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication. arm 4: Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
Interventions: intervention 1: Telcagepant potassium 150 mg intervention 2: Telcagepant potassium 300 mg intervention 3: Zolmitriptan 5 mg intervention 4: Placebo to telcagepant 150 mg intervention 5: Placebo to tecagepant 300 mg intervention 6: Placebo to zolmitriptan 5 mg intervention 7: Rescue medication
Intervention descriptions: intervention 1: Telcagepant 150 mg liquid-filled soft gel capsules intervention 2: Telcagepant 300 mg liquid-filled soft gel capsules intervention 3: Zolmitriptan 5 mg tablets intervention 4: Placebo to match telcagepant 150 mg liquid-filled soft gel capsules intervention 5: Placebo to match tecagepant 300 mg liquid-filled soft gel capsules intervention 6: Placebo to match zolmitriptan 5 mg tablets intervention 7: If moderate or severe migraine headache pain continues or recurs 2 hours after dose of study drug, participants are allowed to take an optional second dose of study drug or their own non-study rescue migraine medication, which may include analgesics (e.g., nonsteroidal anti-inflammatory drugs \[NSAIDs\] or opiates), anti-emetics, or zolmitriptan. Triptans other than zolmitriptan and ergot derivatives are prohibited for 24 hours following the last dose of study drug.

Protocol documents: