NCT00846495

Pilot Study to Compare Frovatriptan vs. Topiramate for Prevention of Migraine

A Randomized, Single-Blind Pilot Study to Compare the Efficacy and Cost-Effectiveness of Frovatriptan vs. Topiramate for the Prevention of Migraine

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Clinvest · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Subjects enrolled at 2 investigative sites will complete 3 visits. Following Visit 1, during a 1-month Baseline Period, subjects will treat with their usual medication and document any warning signs (Prodrome pre-headache) that a migraine will occur. Following randomization (like a flip of the coin) at Visit 2, subjects will treat daily with topiramate or during Prodrome with frovatriptan. Subjects complete a 2-month Treatment Period before exit at Visit 3.This study will compare the effectiveness of daily treatment vs. treatment during the pre-headache phase for prevention of migraine.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	topiramate	topiramate 25mg 1 tab in PM x 1 week topiramate 25mg 1 tab in AM / 1 tab in PM x 1 week topiramate 25mg 1 tab in AM / 2 tabs in PM x 1 week topiramate 25mg 2 tabs in AM / 2 tabs in PM x 5 weeks
DRUG	frovatriptan	frovatriptan 5mg tab during premonitory phase of migraine

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2009-02-18
• Last updated: 2012-01-13
• Results posted: 2011-08-09

Locations

2 sites across 1 country: United States