Phase
Condition
Migraine (Adult)
Pain (Pediatric)
Oral Facial Pain
Treatment
Comparator: placebo
rizatriptan benzoate
Clinical Study ID
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient has a history of migraine with or without aura for more than one year, withbetween 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
Exclusion Criteria:
Patient is pregnant or breast-feeding
Patient has a history of mostly mild migraines or migraines that resolve within 2hours
Patient has more than 15 headache-days per month or has taken medication for acuteheadache 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 andcervical cancers)
Patient has started taking Selective Serotonin Reuptake Inhibitors (SSRIs) orSerotonin-Norepinephrine Reuptake Inhibitors (SNRIs) or has changed doses within 3months of screening
Patient is taking more than one other migraine prophylactic medication
Patient has repeatedly failed to respond to or tolerate rizatriptan