A Six Month Phase II/III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerabitlity, and Efficacy of Telcagepant (MK-0974) for prevention of Menstrually Related Migraine in Female Patients with Episodic Migraine

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites4,500 target enrollmentStarted: April 22, 2010Last updated: October 22, 2012

Conditions

Trial Snapshot

No summary available.

•1. female who has regular menstrual cycles monthly (22 to 32 days) for at least the last 3 cycles.
•2. history of migraine with or without aura for = 3 months and with =2 migraine attacks per month in the 2 months prior to screening.
•3. headache during menstrual period in at least 2 out of last 3 cycles.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. patient has basilar or hemiplegic migraine headache.
•2. patient has taken medication for acute headache atttack on more than 15 days per month in any of the 3 months prior to screening.
•3. patient is taking migraine prophylactic medication where the prescribed daily dose has changed during the 4 weeks prior to screening.
•4. history of liver disease.
•5. consumes 3 or more alcoholic drinks per day.
•6. history of neoplastic disease = 5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.

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