MK0974 for Migraine Prophylaxis in Patients With Episodic Migraine - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00797667

Purpose

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

Condition	Intervention	Phase
Migraine	Drug: MK0974 Drug: Comparator: Placebo	Phase II

MedlinePlus related topics: Migraine

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase IIa, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of MK0974 for Migraine Prophylaxis in Patients With Episodic Migraine

Further study details as provided by Merck:

Primary Outcome Measures:

Evaluate the efficacy of MK0974 twice daily compared to placebo for prophylactic treatment of migraine and to examine the tolerability and safety of MK0974 twice daily for the prophylactic treatment of migraine. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	600
Study Start Date:	January 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MK0974 + placebo	Drug: MK0974 Arm 1: MK0974 140 mg tablets + MK0974 280 mg placebo tablets, twice daily. Arm 2: MK0974 280 mg tablets + MK0974 140 mg placebo tablets, twice daily. 12 week treatment period.
2: Experimental MK0974 + placebo	Drug: MK0974 Arm 1: MK0974 140 mg tablets + MK0974 280 mg placebo tablets, twice daily. Arm 2: MK0974 280 mg tablets + MK0974 140 mg placebo tablets, twice daily. 12 week treatment period.
3: Placebo Comparator Placebo	Drug: Comparator: Placebo MK0974 140 mg placebo tablets + MK0974 280 mg placebo tablets, twice daily. 12 week treatment period.

Eligibility

Criteria

Inclusion Criteria:

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 MK0974 or MK3207

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797667

Contacts

Contact: Toll Free Number

1-888-577-8839

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_591, MK0974-049
Study First Received:	November 24, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00797667
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Migraine Disorders
Headache
Central Nervous System Diseases

Headache Disorders, Primary
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009