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

• Status: Completed
• Trial end date: 2009-10-22
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Rizatriptan; Topiramate

Criteria

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