A Study of Rizatriptan Co-Administered With Acetaminophen for the Treatment of Acute Migraine
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.
2 other identifiers
interventional
200
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2006
Shorter than P25 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 9, 2006
CompletedFirst Posted
Study publicly available on registry
March 10, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedMay 28, 2008
May 1, 2008
10 months
March 9, 2006
May 27, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
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
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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\*
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Diamond Headache Cliniclead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (7)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Merle Diamond, M.D.
Diamond Headache Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 9, 2006
First Posted
March 10, 2006
Study Start
March 1, 2006
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
May 28, 2008
Record last verified: 2008-05