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.

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.

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*