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.

Diamond Headache Clinic7 sites in 1 country200 target enrollmentMarch 2006

ConditionsMigraine

DrugsRizatriptan co-administered with Acetaminophen

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Migraine
Sponsor: Diamond Headache Clinic
Enrollment: 200
Locations: 7
Primary Endpoint: 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.
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2006

End Date

January 2007

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Diamond Headache Clinic

Eligibility 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\*

Outcomes

Primary Outcomes

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.