A Study of Rizatriptan Co-Administered With Acetaminophen for the Treatment of Acute Migraine
Phase 3
Completed
- Conditions
- Migraine
- Registration Number
- NCT00300924
- Lead Sponsor
- Diamond Headache Clinic
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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*
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 24 hour sustained pain relief Pain 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
Trial Locations
- Locations (7)
Diamond Headache Clinic
🇺🇸Chicago, Illinois, United States
Elkind Headache Center
🇺🇸Mount Vernon, New York, United States
Clinvest
🇺🇸Springfield, Missouri, United States
ClinExcel
🇺🇸West Chester, Ohio, United States
Westside Family Medical Center
🇺🇸Kalamazoo, Michigan, United States
SanFrancisco Headache Clinic
🇺🇸San Francisco, California, United States
Mercy Health Research
🇺🇸St. Louis, Missouri, United States