Acute Treatment of Multiple Migraines With or Without Aura in Adults - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00483704

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
Migraine	Drug: MK0974 Drug: Comparator : placebo (unspecified)	Phase III

MedlinePlus related topics: Headache Migraine

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Merck:

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 ]

Estimated Enrollment:	1800
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MK0974	Drug: 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.
2: Experimental MK0974	Drug: 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.
3: Placebo Comparator MK0974 + Placebo	Drug: Comparator : placebo (unspecified) 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.
4: Placebo Comparator Placebo + MK0974	Drug: Comparator : placebo (unspecified) 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

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

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

Contacts

Contact: Toll Free Number

1-888-577-8839

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_546, MK0974-031
Study First Received:	May 15, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00483704
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

multiple attacks of moderate to severe migraine headaches

Study placed in the following topic categories:

Migraine Disorders
Headache
Central Nervous System Diseases

Headache Disorders, Primary
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009