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
  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 Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Sharp & Dohme Corp.:
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 August 18, 2014