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NCT00111709 Clinical Trial

Study to Test a Marketed Drug in the Treatment of Menstrual Migraine (0462-071)

Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00111709
Other study ID # 0462-071
Secondary ID 2005_024
Status Completed
Phase Phase 3
First received
Last updated
Start date May 27, 2005
Est. completion date February 26, 2006

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 393
Est. completion date February 26, 2006
Est. primary completion date February 24, 2006
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0462, rizatriptan benzoate / Duration of Treatment -1 day

• Comparator: placebo / Duration of Treatment - 1 day

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (2)

Mannix LK, Loder E, Nett R, Mueller L, Rodgers A, Hustad CM, Ramsey KE, 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. — View Citation

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. doi: 10.1111/j.1526-4610.2008.01093.x. Epub 2008 Apr 14. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients with 2 hour pain relief: 4-point headache severity scale as recorded in patient diary
Secondary Percentage of patients with 24-hr sustained pain relief: headache severity between 2 and 24 hrs post dose as recorded in patient diary
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