Telcagepant for Prevention of Menstrually Related Migraine in Female Patients With Episodic Migraine (MK-0974-065 AM1)
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT01125774
First received: May 17, 2010
Last updated: July 5, 2012
Last verified: July 2012
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Purpose
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 patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine |
Drug: telcagepant potassium Drug: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Six Month Phase II/III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Telcagepant (MK0974) for Prevention of Menstrually Related Migraine in Female Patients With Episodic Migraine |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Mean monthly headache days during entire study period among participants with menstrually related migraine or pure menstrual migraine who have an average of 5 or more moderate or severe migraine headaches per month at baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Mean monthly headache days during entire study period among participants with menstrually related migraine who have an average of 5 or more moderate or severe migraine headaches per month at baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Mean monthly on-drug headache days during the entire study period among participants with menstrually related migraine or pure menstrual migraine who have an average of 5 or more moderate or severe migraine headaches per month at baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Mean monthly on-drug headache days during the entire study period among participants with menstrually related migraine who have an average of 5 or more moderate or severe migraine headaches per month at baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Mean monthly on-drug headache days during the entire study period among participants with pure menstrual migraine who have an average of 3 or more moderate or severe migraine headaches per month at baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 4582 |
| Study Start Date: | June 2010 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Telcagepant
Drug
|
Drug: telcagepant potassium
Patient will administer 140 mg dose of telcagepant once daily at bedtime for 7 days, beginning at onset of menses, for 6 months.
Other Name: MK-0974
|
|
Placebo Comparator: Placebo
Placebo Comparator
|
Drug: Placebo
Patient will administer placebo to match 140 mg dose of telcagepant once daily at bedtime for 7 days, beginning at onset of menses, for 6 months.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 with in 4 weeks prior to screening
- Participant has history of significant liver disease
- Participant has had cardiac surgery or symptoms with in 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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Vice President, Late State Development Group Leader, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT01125774 History of Changes |
| Other Study ID Numbers: | MK0974-065, 2010_535 |
| Study First Received: | May 17, 2010 |
| Last Updated: | July 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Merck:
|
Menstrually related migraine migraine Premenstrual migraine |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Disorders, Primary Headache Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013