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Study to Test Rizatriptan in the Early Treatment of Acute Migraine (0462-081)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Migraine

Intervention: Comparator: rizatriptan benzoate (Drug); Comparator: Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

The purpose of this study is to test the effectiveness of rizatriptan benzoate 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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Number of Participants Who Are Pain Free at 2 Hours Post-Dose

Secondary outcome:

Number of Participants With 24-Hour Sustained Pain Freedom

Number of Participants With no Rescue Use up to 24 Hours Post-Dose

Number of Participants With Absence of Photophobia at 2 Hours Post-dose

Number of Participants With Absence of Phonophobia at 2 Hours Post-dose

Number of Participants With Absence of Nausea at 2 Hours Post-dose

Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose

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

MedWatch - FDA maintained medical product safety Information

Merck: Patient & Caregiver U.S. Product Web Site

Related publications:

Cady RK, Martin VT, GĂ©raud G, Rodgers A, Zhang Y, Ho AP, Hustad CM, Ho TP, Connor KM, Ramsey KE. Rizatriptan 10-mg ODT for early treatment of migraine and impact of migraine education on treatment response. Headache. 2009 May;49(5):687-96.

Starting date: October 2007
Last updated: July 21, 2015

Page last updated: August 23, 2015

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