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

NCT ID: NCT00662818

Last Updated: 2018-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-17
• Study Completion Date: 2009-09-02

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg

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.

Group Type: EXPERIMENTAL

Telcagepant

Intervention Type: DRUG

Telcagepant (MK-0974) (300 mg soft gel capsules or 280 mg tablets)

Acetaminophen/Paracetamol

Intervention Type: DRUG

Acetaminophen/Paracetamol (500 mg X 2 dosage units)

Placebo to Telcagepant

Intervention Type: DRUG

Placebo 300 mg soft gel capsules or placebo 280 mg tablet.

Placebo to Acetaminophen/Paracetamol

Intervention Type: DRUG

Placebo to acetaminophen/paracetamol (500 mg X 2 dosage units)

Placebo and APAP 1000 mg→Telcagepant 300 mg

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.

Group Type: EXPERIMENTAL

Telcagepant

Intervention Type: DRUG

Telcagepant (MK-0974) (300 mg soft gel capsules or 280 mg tablets)

Acetaminophen/Paracetamol

Intervention Type: DRUG

Acetaminophen/Paracetamol (500 mg X 2 dosage units)

Placebo to Telcagepant

Intervention Type: DRUG

Placebo 300 mg soft gel capsules or placebo 280 mg tablet.

Placebo to Acetaminophen/Paracetamol

Intervention Type: DRUG

Placebo to acetaminophen/paracetamol (500 mg X 2 dosage units)

Interventions

Telcagepant

Telcagepant (MK-0974) (300 mg soft gel capsules or 280 mg tablets)

Intervention Type: DRUG

Acetaminophen/Paracetamol

Acetaminophen/Paracetamol (500 mg X 2 dosage units)

Intervention Type: DRUG

Placebo to Telcagepant

Placebo 300 mg soft gel capsules or placebo 280 mg tablet.

Intervention Type: DRUG

Placebo to Acetaminophen/Paracetamol

Placebo to acetaminophen/paracetamol (500 mg X 2 dosage units)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Ho TW, Ho AP, Chaitman BR, Johnson C, Mathew NT, Kost J, Fan X, Aurora SK, Brandes JL, Fei K, Beebe L, Lines C, Krucoff MW. Randomized, controlled study of telcagepant in patients with migraine and coronary artery disease. Headache. 2012 Feb;52(2):224-35. doi: 10.1111/j.1526-4610.2011.02052.x. Epub 2012 Jan 6.

Reference Type: DERIVED

PMID: 22221076 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

MK-0974-034

Identifier Type: OTHER

Identifier Source: secondary_id

2007_545

Identifier Type: OTHER

Identifier Source: secondary_id

0974-034

Identifier Type: -

Identifier Source: org_study_id