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

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

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	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover 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

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Heart Diseases Migraine Peripheral Arterial Disease Transient Ischemic Attack Vascular Diseases

Drug Information available for: Acetaminophen CT 2584

U.S. FDA Resources

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
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)
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 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
Patients must use acceptable contraception throughout the study

Exclusion Criteria:

patient is pregnant, breast-feeding, or planning to become pregnant during this study
patient was 50 years of age or older when migraines began
patient has other pain syndromes that might interfere with study assessments, uncontrolled 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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_545, MK0974-034
Study First Received:	April 17, 2008
Last Updated:	September 11, 2009
ClinicalTrials.gov Identifier:	NCT00662818 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Cerebral Infarction
Physiological Effects of Drugs
Headache Disorders, Primary
Brain Diseases
Cerebrovascular Disorders
Headache Disorders
Migraine Disorders
Sensory System Agents
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases
Analgesics
Acetaminophen

Ischemic Attack, Transient
Peripheral Vascular Diseases
Heart Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases
Pharmacologic Actions
Analgesics, Non-Narcotic
Brain Infarction
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009