Clinical trial NCT01125774: Telcagepant for Prevention of Menstrually Related Migraine in Female Participants With Episodic Migraine (MK-0974-065)
Official title: A Six Month Phase II/III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Telcagepant (MK-0974) for Prevention of Menstrually Related Migraine in Female Patients With Episodic Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Migraine
Keywords: Menstrually related migraine
migraine
Premenstrual migraine
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-05-18
Enrollment: 4548
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Clinical Adverse Events (AEs)
timeFrame: Up to 14 days after the last dose of study drug (Up to 6.5 months)
measure: Number of Participants Who Discontinued Study Due to a Clinical AE
timeFrame: Up to 6 months
measure: Number of Participants With Laboratory AEs
timeFrame: Up to 6 months
measure: Number of Participants Who Discontinued Study Due to a Laboratory AE
timeFrame: Up to 6 months
measure: Mean Monthly Headache Days During Entire Study Period Among Participants With Menstrually-related Migraine (MRM) or Pure Menstrual Migraine (PMM) Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline
timeFrame: Up to 6 months
Secondary outcomes:
measure: Mean Monthly Headache Days During Entire Study Period Among Participants With MRM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline
timeFrame: Up to 6 months
measure: Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With MRM or PMM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline
timeFrame: Up to 6 months
measure: Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With MRM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline
timeFrame: Up to 6 months
measure: Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With PMM Who Have an Average of 3 or More Moderate or Severe Migraine Headaches Per Month at Baseline
timeFrame: Up to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.