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Study to Test a Marketed Drug in the Treatment of Menstrual Migraine
This study has been completed.
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00111722
  Purpose

The purpose of this study is to test the effectiveness of a marketed drug in the treatment of a menstrual migraine attack.


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: Headache Menstruation 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-Group, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg Tablets for the Treatment of Menstrual Migraine

Further study details as provided by Merck:

Primary Outcome Measures:
  • Percentage of patients with 2 hour pain relief: 4-point headache severity scale as recorded in patient diary

Secondary Outcome Measures:
  • Percentage of patients with 24-hr sustained pain relief: headache severity between 2 and 24 hrs post dose recorded in patient diary

Enrollment: 393
Study Start Date: May 2005
  Eligibility

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

Inclusion Criteria:

  • Female patient at least 18 years old
  • Patient has menses approximately monthly
  • Patient has at least a 6 month history of migraine and at least a 6 month history of menstrual migraine

Exclusion Criteria:

  • Pregnant and/or nursing mother
  • Cardiovascular disease
  • Uncontrolled hypertension
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00111722

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

Publications:
Mannix L, Loder E, Nett R, Mueller L, Rodgers A, Hustad C, Ramsey K, Skobieranda F. Rizatriptan for the acute treatment of ICHD-II proposed menstrual migraine: two prospective, randomized, placebo-controlled, double-blind studies. Cephalalgia. 2007 May;27(5):414-21.

Study ID Numbers: 2005_025
Study First Received: May 24, 2005
Last Updated: May 17, 2007
ClinicalTrials.gov Identifier: NCT00111722  
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
 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 16, 2009



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