Treatment of Migraine in Patients With Stable Vascular Disease (0974-034)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00662818
First received: April 17, 2008
Last updated: November 18, 2013
Last verified: November 2013
  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: Comparator: MK0974
Drug: Comparator: acetaminophen
Drug: Comparator: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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:
  • Number of confirmed vascular event within 48 hours after any dose of study medication. [ Time Frame: following 12 weeks of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 165
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
Active Comparator: 1
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 (1000 mg dry filled capsules) over the 2nd six week treatment period.
Drug: Comparator: MK0974
MK0974 (300 mg soft gel capsules or 280 mg tablets)
Drug: Comparator: acetaminophen
acetaminophen (500 mg X 2 dosage units)
Active Comparator: 2
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: Comparator: MK0974
MK0974 (300 mg soft gel capsules or 280 mg tablets)
Drug: Comparator: acetaminophen
acetaminophen (500 mg X 2 dosage units)
Drug: Comparator: Placebo
placebo (0 mg 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 coronary artery 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 Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00662818     History of Changes
Other Study ID Numbers: 0974-034, MK0974-034, 2007_545
Study First Received: April 17, 2008
Last Updated: November 18, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ischemic Attack, Transient
Heart Diseases
Cerebral Infarction
Stroke
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Migraine Disorders
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cardiovascular Diseases
Brain Infarction
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Headache Disorders, Primary
Headache Disorders
Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014