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

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:

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

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 ]

Enrollment:	1800
Study Start Date:	August 2008
Study Completion Date:	April 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

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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00483704 History of Changes
Other Study ID Numbers:	2007_546, MK0974-031
Study First Received:	May 15, 2007
Last Updated:	September 3, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

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 May 16, 2013