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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Migraine

Treatments: Drug: Telcagepant; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01125774

0974-065

2010_535 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 4,548 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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4,548 participants in 2 patient groups, including a placebo group

Telcagepant

Experimental group

Description:

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.

Treatment:

Drug: Telcagepant

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo