MK0974 (Telcagepant) for Migraine Prophylaxis in Patients With Episodic Migraine (0974-049)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Migraine

Treatments: Drug: Telcagepant 280 mg; Drug: Telcagepant 140 mg; Drug: 140 mg telcagepant placebo; Drug: 280 mg telcagepant placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00797667

0974-049

2008_591

Details and patient eligibility

About

A study to assess the safety and efficacy of MK0974 for preventing migraines in patients with episodic migraine.

Enrollment: 660 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is 18 years of age or older
• Patient has had a history of migraine with or without aura
• Patient is able to complete study questionnaire(s) and paper diary

Exclusion criteria

• Patient is pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of the study
• Patient has basilar or hemiplegic migraine headache, hepatitis or psychiatric conditions
• Patient was older than 50 years of age at migraine onset
• History of gastric or small intestinal surgery or has a disease that causes malabsorption
• Patient has heart attack, unstable angina, coronary artery bypass surgery or other revascularization procedure, stroke, or transient ischemic attack 3 months before starting the study
• Currently participating or has participated in a study with an investigational compound or device within 30 days of starting the study
• Currently participating in a study with MK-0974 or MK-3207

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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660 participants in 3 patient groups, including a placebo group

Telcagepant 140 mg

Experimental group

Description:

Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks

Treatment:

Drug: 280 mg telcagepant placebo

Drug: Telcagepant 140 mg

Telcagepant 280 mg

Experimental group

Description:

Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks

Treatment:

Drug: 140 mg telcagepant placebo

Drug: Telcagepant 280 mg

Placebo

Placebo Comparator group

Description:

Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks

Treatment:

Drug: 280 mg telcagepant placebo

Drug: 140 mg telcagepant placebo