Telcagepant (MK-0974) Treatment of Migraine in Participants With Stable Vascular Disease (MK-0974-034)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: TIA (Transient Ischemic Attack); Cerebrovascular Accident; Peripheral Vascular Diseases; Migraine Disorders; Vascular Diseases; Heart Disease

Treatments: Drug: Placebo to Telcagepant; Drug: Placebo to Acetaminophen/Paracetamol; Drug: Acetaminophen/Paracetamol; Drug: Telcagepant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00662818

MK-0974-034 (Other Identifier)

2007_545 (Other Identifier)

0974-034

Details and patient eligibility

About

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.

Enrollment: 165 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stable coronary artery disease for 3 months or more
• 18 years of age or older with a history of migraine with or without aura
• Must use acceptable contraception throughout the study

Exclusion criteria

• Pregnant, breast-feeding, or planning to become pregnant during this study
• 50 years of age or older when migraines began
• Other pain syndromes that might interfere with study assessments, uncontrolled psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
• History of gastric, or small intestinal surgery, or has a disease that causes malabsorption

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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165 participants in 2 patient groups

Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg

Experimental group

Description:

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.

Treatment:

Drug: Acetaminophen/Paracetamol

Drug: Placebo to Telcagepant

Drug: Placebo to Acetaminophen/Paracetamol

Drug: Telcagepant

Placebo and APAP 1000 mg→Telcagepant 300 mg

Experimental group

Description:

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.

Treatment:

Drug: Acetaminophen/Paracetamol

Drug: Placebo to Telcagepant

Drug: Placebo to Acetaminophen/Paracetamol

Drug: Telcagepant