Telcagepant for Prevention of Menstrually Related Migraine in Female Participants With Episodic Migraine (MK-0974-065)

• Status: Completed
• Trial end date: 2011-04-08
• Target enrollment: 0
• Participant gender: Female

Summary

This is a multicenter study to test the hypothesis that telcagepant is superior to placebo in preventing perimenstrual migraines as measured by mean monthly headaches during the entire treatment period. This study will also evaluate the safety and tolerability of telcagepant for female migraine participants.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

• Participant who has had regular menstrual cycles monthly (22 to 32 days) for at least the last 3 cycles

• Participant experiences headache during menstrual period in at least 2 out of last 3 cycles

• Participant has history of migraine for ≥ 3 months and with ≥ 2 migraine attacks per month in the 2 months prior to screening

• Participant agrees to use an effective method of birth control through the duration of the study

Exclusion Criteria:

• Participant has basilar or hemiplegic migraine headache

• Participant has taken medication for acute headache on more than 15 days per month in the 3 months prior to screening

• Participant is taking prophylactic medication for migraine and daily dose has changed within 4 weeks prior to screening

• Participant has history of significant liver disease

• Participant has had cardiac surgery or symptoms within 3 months of screening

• Participant has confounding pain syndromes, psychiatric conditions, dementia, or major neurological disorders other than migraine

• Participant has history of neoplastic disease ≤ 5 years prior to signing informed consent

• Participant has history of gastric or small intestinal surgery

• Participant consumes 3 or more alcoholic drinks per day