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Study to Test a Marketed Drug (MK0462) in the Early Treatment of Acute Migraine

Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Migraine

Intervention: rizatriptan benzoate (Drug); Comparator: placebo (unspecified) (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Merck

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck

Summary

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

Clinical Details

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Factorial Design Clinical Trial to Study the Efficacy and Safety of MK0462 / Rizatriptan 10 mg for the Early Treatment of Acute Migraine

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Percentage of patients who are pain free

Tolerability as measured by subjective adverse experience reporting

Secondary outcome: Percentage of patients with 24hr sustained pain freedom, associated symptoms, and use of rescue medication

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Greater than one year history of migraine

- Attacks typically mild when they begin and progress to moderate or severe

- Experience 1-4 migraine attacks per month

Exclusion Criteria:

- More than 15 headache days per month

- Heart disease

- Uncontrolled high blood pressure

Locations and Contacts

Additional Information

Starting date: August 2007
Last updated: February 27, 2008

Page last updated: June 20, 2008

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