A Study of Rizatriptan Co-Administered With Acetaminophen for the Treatment of Acute Migraine
Information source: Diamond Headache Clinic
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine
Intervention: Rizatriptan co-administered with Acetaminophen (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Diamond Headache Clinic Official(s) and/or principal investigator(s):
Merle Diamond, M.D., Study Director, Affiliation: Diamond Headache Clinic
Summary
The purpose of this study is to test an experimental drug combination of two medications
currently approved by the Food and Drug Administration (FDA) for migraine headache or other
pain. These are called rizatriptan given with acetaminophen.
Clinical Details
Official title: A Double-Blind, Double-Dummy, Randomized, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of Rizatriptan 10mg Co-Administered With Acetaminophen for the Treatment of Acute Migraine.
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To compare the efficacy of rizatriptan co-administered with acetaminophen to placebo, acetaminophen and rizatriptan for the acute treatment of migraine, as measured by the percentage of patients with pain relief at 2 hours.
Secondary outcome: 24 hour sustained pain reliefPain relief at 30, 45,60,90 minutes and 4 hours post dose Pain freedom at 30,45,60,90 minutes and 2 and 4 hours post dose 24 sustained pain freedom Associated symptoms of phonophobia, photophobia, nausea and vomiting Functional disability Use of rescue medication Self-reported adverse experiences
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subject is at least 18 years of age
- Subject has at least a 6 month history of migraine, with or without aura
- Subject can distinguish between migraine attacks and other types of headaches
- Subject of childbearing potential agrees to use adequate contraception
Exclusion Criteria:
- Subject typically has fewer than 1 or greater than 6 migraine attacks per month
- Subject typically has greater than 10 headache days per month
- Subject has evidence of ischemic heart disease
- Subject has uncontrolled high blood pressure
- Subject has a history, within 1 year, or current evidence of drug or alcohol abuse
*This list is not all inclusive*
Locations and Contacts
SanFrancisco Headache Clinic, San Francisco, California 94109, United States
Diamond Headache Clinic, Chicago, Illinois 60614, United States
Westside Family Medical Center, Kalamazoo, Michigan 49009, United States
Clinvest, Springfield, Missouri, United States
Mercy Health Research, St. Louis, Missouri 63141, United States
Elkind Headache Center, Mount Vernon, New York 10550, United States
ClinExcel, West Chester, Ohio 44121, United States
Additional Information
Starting date: March 2006
Ending date: January 2007
Last updated: May 27, 2008
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