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Treatment of Migraine in Patients With Stable Vascular Disease

This study is currently recruiting participants.
Verified by Merck, September 2008

Sponsored by: 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 (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  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




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