Treatment of Migraine in Patients With Stable Vascular Disease - Full Text View

Purpose

The purpose of this study is to evaluate the safety and efficacy of MK0974 in the treatment of acute migraine in patients with stable vascular disease.

Condition	Intervention	Phase
Migraine Disorders Heart Disease Cerebrovascular Accident TIA (Transient Ischemic Attack) Vascular Diseases Peripheral Vascular Diseases	Drug: MK0974 Drug: Comparator: acetaminophen Drug: Comparator: Placebo (unspecified)	Phase III

Genetics Home Reference related topics:

familial hemiplegic migraine

MedlinePlus related topics:

Heart Diseases Migraine Peripheral Vascular Diseases Transient Ischemic Attack Vascular Diseases

ChemIDplus related topics:

Acetaminophen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Multicenter, Randomized, Double-Blind, Placebo- and Active Controlled, Crossover Study to Evaluate the Safety and Efficacy of MK0974 in the Treatment of Acute Migraine in Patients With Stable Vascular Disease

Further study details as provided by Merck:

Primary Outcome Measures:

To evaluate the efficacy of MK0974 compared to placebo in the treatment of acute migraine in patients with stable vascular disease, as measured by pain freedom at 2 hours post dose. [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the safety and tolerability of MK0974 compared to acetaminophen/paracetamol in the treatment of acute migraine in patients with stable vascular disease following 12 weeks of treatment. [ Time Frame: following 12 weeks of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	400
Study Start Date:	March 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment group 1: Active Comparator Crossover study: All migraine attacks to be treated with up to 12 doses of MK0974 over the 1st six week treatment period. This will be followed by up to 12 doses of acetaminophen/paracetamol(1000mg dry filled capsules) over the 2nd six week treatment period.	Drug: MK0974 MK0974 (300mg soft gel capsules) Drug: Comparator: acetaminophen acetaminophen(1000mg dry filled capsules)
Treatment group 2: Active Comparator Crossover study: All migraine attacks to be treated with one dose of placebo and up to 11 doses of acetaminophen over the 1st six week treatment period. This will be followed by up to 12 doses of MK0974 over the 2nd six week treatment period.	Drug: MK0974 MK0974 (300mg soft gel capsules) Drug: Comparator: acetaminophen acetaminophen(1000mg dry filled capsules) Drug: Comparator: Placebo (unspecified) placebo (0mg soft gel capsules)

Eligibility

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

Criteria

Inclusion Criteria:

Patient has stable vascular disease (heart, brain, or blood vessel disease) for 3 months or more
Patient is 18 years of age or older with a history of migraine with or without aura for more than 1 year with 1-8 moderate or severe migraine attacks per month that last longer than 2 hours
Patient must agree to remain abstinent or to use 2 acceptable forms of birth control during this study

Exclusion Criteria:

Patient is pregnant, breast-feeding, or planning to become pregnant during this study
Patient is unable to identify migraine headaches from non-migraine headaches
Patient has history of only mild migraine attacks or attacks that resolve 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 per month in any of the 3 months prior to screening
Patient was 50 years of age or older when migraines began
Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
Patient has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662818

Contacts


Contact: Toll Free Number	1-888-577-8839

Show 28 Study Locations

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_545, MK0974-034
First Received:	April 17, 2008
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00662818
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Ischemic Attack, Transient

Heart Diseases

Peripheral Vascular Diseases

Cerebral Infarction

Stroke

Vascular Diseases

Central Nervous System Diseases

Headache Disorders, Primary

Ischemia

Brain Diseases

Cerebrovascular Disorders

Headache Disorders

Migraine Disorders

Headache

Brain Ischemia

Brain Infarction

Infarction

Acetaminophen

Additional relevant MeSH terms:

Sensory System Agents

Analgesics, Non-Narcotic

Therapeutic Uses

Physiological Effects of Drugs

Nervous System Diseases

Cardiovascular Diseases

Peripheral Nervous System Agents

Analgesics

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00662818