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

0462-085

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

2009-03-24

2009-10-22

2009-10-22

Completed

Early phase I

108

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 108, 'type': 'ACTUAL'}}

2024-05-23