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Study to Test an Approved Product in the Early Treatment of Migraine
This study has been completed.
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00092963
  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 III

Genetics Home Reference related topics: familial hemiplegic migraine
MedlinePlus related topics: Migraine
Drug Information available for: Rizatriptan Benzoate Rizatriptan Potassium benzoate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Merck:

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

Secondary Outcome Measures:
  • % of pts with 24 hr sustained pain freedom
  • % of pts free @30/45/60/90 mins postdose
  • % of pts with associated symptoms @2hr
  • % of pts requiring rescue med btwn 2&24 hr
  • % of pts with functional disabilty @2hr

Estimated Enrollment: 510
Study Start Date: August 2004
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092963

  Show 46 Study Locations
Sponsors and Collaborators
Merck
  More Information

Publications:
Cady R, Martin V, Mauskop A, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Efficacy of Rizatriptan 10 mg administered early in a migraine attack. Headache. 2006 Jun;46(6):914-24.

Publications indexed to this study:
Martin V, Cady R, Mauskop A, Seidman LS, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Efficacy of rizatriptan for menstrual migraine in an early intervention model: a prospective subgroup analysis of the rizatriptan TAME (Treat A Migraine Early) studies. Headache. 2008 Feb;48(2):226-35. Epub 2007 Nov 13.

Study ID Numbers: 2004_022
Study First Received: September 28, 2004
Last Updated: July 5, 2006
ClinicalTrials.gov Identifier: NCT00092963  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Benzoates
Migraine Disorders
Headache
Central Nervous System Diseases
Headache Disorders, Primary
 Pain
Rizatriptan
Brain Diseases
Serotonin
Headache Disorders

Additional relevant MeSH terms:
Serotonin Agonists
Neurotransmitter Agents
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
 Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009



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