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
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
Benzoates
Rizatriptan
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 14, 2014