Conditions: Migraine
Keywords: Menstrually related migraine migraine Premenstrual migraine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 4548
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses. arm 2: Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.

Interventions: intervention 1: Telcagepant intervention 2: Placebo
Intervention descriptions: intervention 1: Telcagepant 140 mg film coated tablet for oral administration intervention 2: Placebo to match telcagepant 140 mg film coated tablet for oral administration

Protocol document: