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Study to Test an Approved Product in the Early Treatment of Migraine (0462-065)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092963
First received: September 28, 2004
Last updated: October 16, 2014
Last verified: October 2014
  Purpose

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


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 free at 30/45/60/90 minutes postdose
  • Percentage of patients with associated symptoms at 2 hours
  • Percentage of patients requiring rescue med between 2 & 24 hours
  • Percentage of patients with functional disability at 2 hours

Enrollment: 529
Study Start Date: August 2004
Study Completion Date: January 2005
Primary Completion Date: January 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:

  • 6-month history of migraine
  • 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: NCT00092963

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092963     History of Changes
Other Study ID Numbers: 0462-065, 2004_022
Study First Received: September 28, 2004
Last Updated: October 16, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014