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

NCT ID: NCT01125774

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 4548 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-01
• Study Completion Date: 2011-04-08

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.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Telcagepant

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.

Group Type: EXPERIMENTAL

Telcagepant

Intervention Type: DRUG

Telcagepant 140 mg film coated tablet for oral administration

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to match telcagepant 140 mg film coated tablet for oral administration

Interventions

Telcagepant

Telcagepant 140 mg film coated tablet for oral administration

Intervention Type: DRUG

Placebo

Placebo to match telcagepant 140 mg film coated tablet for oral administration

Intervention Type: DRUG

Other Intervention Names

MK-0974

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Ho TW, Ho AP, Ge YJ, Assaid C, Gottwald R, MacGregor EA, Mannix LK, van Oosterhout WP, Koppenhaver J, Lines C, Ferrari MD, Michelson D. Randomized controlled trial of the CGRP receptor antagonist telcagepant for prevention of headache in women with perimenstrual migraine. Cephalalgia. 2016 Feb;36(2):148-61. doi: 10.1177/0333102415584308. Epub 2015 Apr 29.

Reference Type: RESULT

PMID: 25926620 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

2010_535

Identifier Type: OTHER

Identifier Source: secondary_id

0974-065

Identifier Type: -

Identifier Source: org_study_id