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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01125774
First received: May 17, 2010
Last updated: July 5, 2012
Last verified: July 2012

May 17, 2010
July 5, 2012
June 2010
April 2011   (final data collection date for primary outcome measure)
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 ]
Mean monthly headache days while on drug [ Time Frame: 1 week for each month for 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01125774 on ClinicalTrials.gov Archive Site
  • 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 ]
Mean monthly headache days during entire treatment [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Telcagepant for Prevention of Menstrually Related Migraine in Female Patients With Episodic Migraine (MK-0974-065 AM1)
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Migraine
  • 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.
  • Experimental: Telcagepant
    Drug
    Intervention: Drug: telcagepant potassium
  • Placebo Comparator: Placebo
    Placebo Comparator
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4582
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01125774
MK0974-065, 2010_535
Yes
Vice President, Late State Development Group Leader, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP