Study to Test an Approved Product in the Early Treatment of Migraine

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00095004
First received: October 29, 2004
Last updated: January 21, 2010
Last verified: January 2010
  Purpose

The purpose of this study is to test the effectiveness of an approved drug in the early treatment of migraine.


Condition Intervention Phase
Migraine
Drug: MK0462, rizatriptan benzoate / Duration of Treatment: 1day
Drug: Comparator: placebo / 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, Randomized, Parallel, Placebo-Controlled Study to Examine the Efficacy of Rizatriptan 10 mg Tablet Administered Early During a Migraine Attack While the Pain is Mild

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage of patients who are pain free at 2 hours postdose
  • Tolerability as measured by subjective adverse experience reporting

Secondary Outcome Measures:
  • Percentage of patients with 24 hour sustained pain freedom
  • Percentage of patients pain free at 30/45/60/90 minutes post dose
  • Percentage of patients with associated symptoms at 2 hours
  • Percentage of patients requiring rescue medication between 2 & 24 hours
  • Percentage of patients with functional disability at 2 hours

Estimated Enrollment: 510
Study Start Date: October 2004
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  • Six month history of migraine; attacks typically mild when they begin with 1-4 migraine attacks per month.

Exclusion Criteria:

  • Heart disease
  • High blood pressure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095004

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00095004     History of Changes
Other Study ID Numbers: 2004_089, MK0462-066
Study First Received: October 29, 2004
Last Updated: January 21, 2010
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
Rizatriptan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 14, 2014