A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine (0462-087)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg for the Treatment of Acute Migraine in Sumatriptan Non-Responders

A study to provide evidence supporting the benefit of Rizatriptan in patients who have an inadequate response to sumatriptan.

Inclusion Criteria:

• Patient has a history of migraine with or without aura for 1 year or more with 2-8 moderate or severe migraine attacks per month
• Patient generally does not respond to treatment with sumatriptan
• Patient of reproductive potential agrees to remain abstinent or use one method of highly effective birth control (i.e. IUD, condoms, hormonal contraceptive, diaphragm, vasectomy) for the duration of the study
• Patient is able to complete paper diary

Exclusion Criteria:

• Patient is pregnant or breast feeding or excepts to become pregnant during the study
• Patient has history of mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours
• Patient has basilar or hemiplegic migraines
• Patient is unable to distinguish between migraine attacks from other types of headaches
• Patient has more than 15 headache-days per month
• Patient was greater than 50 years old at age of migraine onset
• Patient has failed to respond to 3 or more triptans
• Patient has a repeated history of failing to respond to or tolerate rizatriptan
• Patient uses opioids as primary migraine therapy
• Patient uses daily opioids
• Patient has a history of Cerebrovascular Accident (CVA) or other significant cardiovascular disease
• Patient has uncontrolled hypertension
• Patient has a history of neoplastic disease
• Patient is taking a serotonin reuptake inhibitor (SSRI or SNRI) where the dose has changed 3 months prior to screening
• Patient has a history of drug or alcohol abuse