The purpose of this study is to test the effectiveness of a marketed drug in the treatment of a menstrual migraine attack...
Date First Received: May 24, 2005
Last Updated: April 27, 2009
Verified by: Merck, April 2009
Clinical Trial Phase: Phase 3 | Start Date: June 2005
Overall Status: Completed
Estimated Enrollment: 393
Brief Summary
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”
Condition Keyword(s):
The purpose of this study is to test the effectiveness of a marketed drug in the treatment of a menstrual migraine attack.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: MK0462, rizatriptan benzoate / Duration of Treatment -1 day
- Drug: Comparator: placebo / Duration of Treatment - 1 day
Outcome Measures for this Clinical Trial
Primary Measures
- Percentage of patients with 2 hour pain relief: 4-point headache severity scale as recorded in patient diary
Secondary Measures
- Percentage of patients with 24-hr sustained pain relief: headache severity between 2 and 24 hrs post dose as recorded in patient diary
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Female patient at least 18 years old
- Patient has menses approximately monthly
- Patient has at least a 5 month history of migraine and at least a 6 month history of menstrual migraine
Exclusion Criteria:
- Pregnant and/or nursing
- Cardiovascular disease
- Uncontrolled hypertension
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Merck
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Related Publications
References
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.
Nett R, Mannix LK, Mueller L, Rodgers A, Hustad CM, Skobieranda F, Ramsey KE. Rizatriptan efficacy in ICHD-II pure menstrual migraine and menstrually related migraine. Headache. 2008 Sep;48(8):1194-201. Epub 2008 Apr 14.
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00111709
Study ID Number: 2005_024
ClinicalTrials.gov Identifier: NCT00111709
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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