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

This study has been terminated.
(The study was terminated based on a recommendation of the DSMB following the identification of two patients with significant elevations in serum transaminases)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00797667
First received: November 24, 2008
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Migraine
Drug: Comparator: MK0974
Drug: Comparator: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]

Enrollment: 600
Study Start Date: November 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MK0974 + placebo
Drug: Comparator: 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.
Experimental: 2
MK0974 + placebo
Drug: Comparator: 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.
Placebo Comparator: 3
Placebo
Drug: Comparator: Placebo
MK0974 140 mg placebo tablets + MK0974 280 mg placebo tablets, twice daily. 12 week treatment period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 MK0974 or MK3207
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00797667     History of Changes
Other Study ID Numbers: 0974-049, MK0974-049, 2008_591
Study First Received: November 24, 2008
Last Updated: November 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 28, 2014