Telcagepant for Prevention of Menstrually Related Migraine in Female Patients With Episodic Migraine (MK-0974-065 AM1)

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT01125774

First received: May 17, 2010

Last updated: July 5, 2012

Last verified: July 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	May 17, 2010
Last Updated Date	July 5, 2012
Start Date ^ICMJE	June 2010
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 26, 2010)	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 ]
Original Primary Outcome Measures ^ICMJE (submitted: May 17, 2010)	Mean monthly headache days while on drug [ Time Frame: 1 week for each month for 6 months ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01125774 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 26, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: May 17, 2010)	Mean monthly headache days during entire treatment [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Telcagepant for Prevention of Menstrually Related Migraine in Female Patients With Episodic Migraine (MK-0974-065 AM1)
Official Title ^ICMJE	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
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 patients.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Migraine
Intervention ^ICMJE	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 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.
Study Arm (s)	Experimental: Telcagepant Drug Intervention: Drug: telcagepant potassium Placebo Comparator: Placebo Placebo Comparator Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	4582
Completion Date	April 2011
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01125774
Other Study ID Numbers ^ICMJE	MK0974-065, 2010_535
Has Data Monitoring Committee	Yes
Responsible Party	Vice President, Late State Development Group Leader, Merck Sharp & Dohme Corp
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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