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

November 24, 2008
November 22, 2013
November 2008
May 2009   (final data collection date for primary outcome measure)
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 ]
Evaluate the efficacy of MK-0974 twice daily compared to placebo for prophylactic treatment of migraine and to examine the tolerability and safety of MK-0974 twice daily for the prophylactic treatment of migraine. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00797667 on ClinicalTrials.gov Archive Site
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MK0974 for Migraine Prophylaxis in Patients With Episodic Migraine (0974-049)(TERMINATED)
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Migraine
  • 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.
  • Drug: Comparator: Placebo
    MK0974 140 mg placebo tablets + MK0974 280 mg placebo tablets, twice daily. 12 week treatment period.
  • Experimental: 1
    MK0974 + placebo
    Intervention: Drug: Comparator: MK0974
  • Experimental: 2
    MK0974 + placebo
    Intervention: Drug: Comparator: MK0974
  • Placebo Comparator: 3
    Placebo
    Intervention: Drug: Comparator: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
600
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00797667
0974-049, MK0974-049, 2008_591
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP