Acute Treatment of Multiple Migraines With or Without Aura in Adults (0974-031)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00483704
First received: May 15, 2007
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

The purpose of the study is to assess the safety and efficacy of MK0974 in acute treatment of multiple migraine attacks with or without aura.


Condition Intervention Phase
Migraines
Drug: Comparator: MK0974
Drug: Comparator: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Multiple Attacks Study to Compare the Efficacy and Safety of Oral MK0974 With Placebo for the Acute Treatment of Migraine With or Without Aura

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Compare the effectiveness, consistency, and safety of two doses of MK0974 with placebo in patients with acute migraine [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Sustained pain freedom and total migraine freedom [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 1800
Study Start Date: August 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MK0974
Drug: Comparator: MK0974
Patients will have up to 6 months to treat 4 migraine attacks. Arm 1: All 4 migraine attacks will be treated with MK0974 140 mg tablets Arm 2: All 4 migraine attacks will be treated with MK0974 280 mg tablets. All patients will take study drug at time of migraine onset.
Other Name: MK0974
Experimental: 2
MK0974
Drug: Comparator: MK0974
Patients will have up to 6 months to treat 4 migraine attacks. Arm 1: All 4 migraine attacks will be treated with MK0974 140 mg tablets Arm 2: All 4 migraine attacks will be treated with MK0974 280 mg tablets. All patients will take study drug at time of migraine onset.
Other Name: MK0974
Placebo Comparator: 3
Placebo Comparator
Drug: Comparator: Placebo
All patients will have 6 months to treat 4 migraine attacks. Arms 3 and 4: 3 migraine attacks will be treated with placebo and 1 migraine attack will be treated with MK0974 140 mg tablets. All patients will take study drug at time of migraine onset.
Placebo Comparator: 4
Placebo Comparator
Drug: Comparator: Placebo
All patients will have 6 months to treat 4 migraine attacks. Arms 3 and 4: 3 migraine attacks will be treated with placebo and 1 migraine attack will be treated with MK0974 140 mg tablets. All patients will take study drug at time of migraine onset.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has had a history of migraines within the past year
  • Patient has had 1 to 8 moderate or severe migraine attacks per month in the past 2 months that lasted between 4 - 72 if untreated
  • Patients must use acceptable contraception throughout the study
  • Patient is able to complete the study questionnaire(s) and paper diary
  • Limit consumption of grapefruit juice to no more than one 8 ounce glass a day

Exclusion Criteria:

  • Patient is pregnant or breast-feeding or is expecting to become pregnant during the study
  • Patient has difficulty distinguishing his/her migraine attacks from tension or interval headaches
  • Patient has a history of mostly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours
  • Patient has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days a month in the past 3 months
  • Patient was greater than 50 years old at the age of migraine onset
  • Patient has previously taken MK0974
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483704

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00483704     History of Changes
Other Study ID Numbers: 0974-031, MK0974-031, 2007_546
Study First Received: May 15, 2007
Last Updated: September 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
multiple attacks of moderate to severe migraine headaches

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 01, 2014