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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

660 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-12

Study Completion Date

2009-05-20

Brief Summary

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

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Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Telcagepant 140 mg

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

Group Type EXPERIMENTAL

Telcagepant 140 mg

Intervention Type DRUG

280 mg telcagepant placebo

Intervention Type DRUG

Telcagepant 280 mg

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

Group Type EXPERIMENTAL

Telcagepant 280 mg

Intervention Type DRUG

140 mg telcagepant placebo

Intervention Type DRUG

Placebo

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

Group Type PLACEBO_COMPARATOR

140 mg telcagepant placebo

Intervention Type DRUG

280 mg telcagepant placebo

Intervention Type DRUG

Interventions

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Telcagepant 140 mg

Intervention Type DRUG

Telcagepant 280 mg

Intervention Type DRUG

140 mg telcagepant placebo

Intervention Type DRUG

280 mg telcagepant placebo

Intervention Type DRUG

Other Intervention Names

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MK-0974 MK-0974

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No