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MK0974 Pivotal Study 1 - WW (With Active Comparator)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00442936
First received: February 28, 2007
Last updated: January 30, 2009
Last verified: January 2009
History of Changes
  Purpose

The purpose of this study is to investigate the efficacy and safety of MK0974 compared to an approved medication for acute migraine.


Condition Intervention Phase
Migraine
 Drug: MK0974 / Duration of Treatment: 1 Day
Drug: Comparator: zolmitriptan / Duration of Treatment: 1 Day
Drug: Comparator: placebo (unspecified) / Duration of Treatment: 1 Day
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Study to Compare the Response to a Single Treatment With Oral MK0974 With Placebo and Comparator in Subjects With Moderate to Severe Acute Migraine With or Without Aura

Resource links provided by NLM:

MedlinePlus related topics: Migraine
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Pain Freedom at 2 hours post-dose, Pain Relief at 2 hours post-dose, Absence of photophobia, phonophobia, and nausea at 2 hrs post-dose

Secondary Outcome Measures:
  • Sustained Pain-Freedom from 2 to 24 hours after study drug administration, Total Migraine Freedom at 2 hours post-dose, Total Migraine Freedom from 2 to 24 hours post-dose

Estimated Enrollment: 1800
Study Start Date: March 2007
Study Completion Date: October 2007
  Eligibility

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

Inclusion Criteria:

  • Patient has at least 1 year history of migraine (with or without aura)
  • Females of child bearing potential must use acceptable contraception throughout trial

Exclusion Criteria:

  • Patient is pregnant/breast-feeding (or is a female expecting to conceive during study period)
  • Patient has history or evidence of stroke/transient ischemic attacks, heart disease, coronary artery vasospasm, other significant underlying cardiovascular diseases, uncontrolled hypertension (high blood pressure), uncontrolled diabetes, or HIV disease
  • 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
  • Patient has a history of cancer within the last 5 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00442936

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Publications:

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: NCT00442936     History of Changes
Other Study ID Numbers: 2006_525, MK0974-011
Study First Received: February 28, 2007
Last Updated: January 30, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Zolmitriptan
 Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013