Conditions: Migraine Disorders Heart Disease Cerebrovascular Accident TIA (Transient Ischemic Attack) Vascular Diseases Peripheral Vascular Diseases
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 165
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of telcagepant in the treatment of acute migraine in participants with stable vascular disease. Acetaminophen/paracetamol (APAP) will be used as an active comparator in this study. The primary hypothesis of this study is that telcagepant 300 mg is superior to placebo.

Detailed description:

Arms:
arm 1: Participants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned. arm 2: Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.

Interventions: intervention 1: Telcagepant intervention 2: Acetaminophen/Paracetamol intervention 3: Placebo to Telcagepant intervention 4: Placebo to Acetaminophen/Paracetamol
Intervention descriptions: intervention 1: Telcagepant (MK-0974) (300 mg soft gel capsules or 280 mg tablets) intervention 2: Acetaminophen/Paracetamol (500 mg X 2 dosage units) intervention 3: Placebo 300 mg soft gel capsules or placebo 280 mg tablet. intervention 4: Placebo to acetaminophen/paracetamol (500 mg X 2 dosage units)

Protocol document: