Migraine
Conditions
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.
Interventions
DRUGRizatriptan co-administered with Acetaminophen
Sponsors
Merck Sharp & Dohme LLC
Diamond Headache Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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\*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
| 24 hour sustained pain relief | — |
| Functional disability | — |
| Use of rescue medication | — |
| Self-reported adverse experiences | — |
| Associated symptoms of phonophobia, photophobia, nausea and vomiting | — |
Countries
United States
Outcome results
None listed