A Study of Rizatriptan for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg ODT for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis

This study will provide additional efficacy data for rizatriptan when used for an acute migraine attack in patients already taking topiramate for migraine prophylaxis.

Inclusion Criteria:

• Patient has a history of migraine with or without aura for more than one year, with between 2 and 8 moderate to severe attacks per month
• Patient is currently taking at least 50 mg topiramate daily for migraine prophylaxis
• Patient can distinguish between migraine and other types of headache
• Patient agrees to remain abstinent or use effective birth control during the study

Exclusion Criteria:

• Patient is pregnant or breast-feeding
• Patient has a history of mostly mild migraines or migraines that resolve within 2 hours
• Patient has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in the 3 months prior to screening.
• Patient was > 50 years old at age of migraine onset
• Patient has history of heart disease
• Patient has uncontrolled hypertension
• Patient has had cancer within 5 years of screening (excepting certain skin and cervical cancers)
• Patient has started taking Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) or has changed doses within 3 months of screening
• Patient is taking more than one other migraine prophylactic medication
• Patient has repeatedly failed to respond to or tolerate rizatriptan