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 FreedomNumber 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
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