Phase 3
N=4,548
Telcagepant for Prevention of Menstrually Related Migraine in Female Participants With Episodic Migraine (MK-0974-065)
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT01125774 ↗Enrolled (actual)
4,548
Serious AEs
0.9%
Results posted
Oct 2014
Primary outcome: Primary: Number of Participants With Clinical Adverse Events (AEs) — 1582; 804 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Telcagepant (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Adverse Events (AEs) |
1582; 804 | — |
| PRIMARY Number of Participants Who Discontinued Study Due to a Clinical AE |
66; 36 | — |
| PRIMARY Number of Participants With Laboratory AEs |
76; 30 | — |
| PRIMARY Number of Participants Who Discontinued Study Due to a Laboratory AE |
8; 2 | — |
| PRIMARY 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 |
8.8; 9.3 | 0.130 |
| SECONDARY 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 |
9.3; 9.6 | 0.369 |
| SECONDARY 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 |
2.5; 2.9 | <0.001 sig |
| SECONDARY 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 |
2.6; 3.0 | <0.001 sig |
| SECONDARY 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 |
2.1; 2.2 | 0.393 |
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
Data sourced from ClinicalTrials.gov (NCT01125774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.