NCT00216619

The Prolonged Use of Topiramate for Preventing Migraine Headaches

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial to Investigate the Efficacy and Tolerability of Topiramate in Prolonged Migraine Prevention

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 834 (actual)
• Sponsor: Janssen Pharmaceutica N.V., Belgium · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness (beyond 6 months) of individualized doses (100 to 200 milligrams) of topiramate for the prevention of migraine headaches over a period of 26 weeks.

Detailed description

Previous studies have shown that topiramate is effective in preventing migraine headaches. This study will start with a 4-week baseline period in which no treatment is given, followed by a 26-week period in which each patient's dose is adjusted and then kept stable for 4 weeks. The dose will start at 25 milligrams of topiramate per day and will be increased 25 milligrams per day once weekly and then raised to either the target--100 milligrams per day--or the maximum dose that is well tolerated up to 200 milligrams per day. Patients randomized to receive topiramate will remain on that dose. The comparison phase of the study is a 26-week period in which the change in migraine days of patients on topiramate (taking at least 50 milligrams per day) is compared with the change in migraine days for patients on the placebo. Also studied will be the patients' health-related quality of life as assessed by questionnaires filled out at specific visits as well as the patients' views of the safety and tolerability of topiramate. The study hypothesis is that the number of migraine days, periods, and attacks during the last 4 weeks of the double-blind phase, relative to the last 4 weeks of the open-label phase, is reduced more in the topiramate group than the placebo group. During open-label (26-weeks) and double-blind phase (26-weeks), patients receiving topiramate will take 25 milligrams to 100 milligrams daily by mouth; increased by 25 milligrams per day once weekly; dose cannot exceed 200 milligrams per day and must be stable for the last 4 weeks.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Topiramate	topiramate treatment started with one tablet per day, taken in the evening, for the first 7 days of the OL phase. Each tablet contained 25 mg topiramate. After one week, the dose was raised to two tablets per day: one tablet was taken in the morning, the other in the evening.
DRUG	Topiramate - Placebo	the trial medication consisted of topiramate 25 mg tablets or matching placebo tablets which were identical in appearance, taste and smell. DB randomisation phase (after the 26-weeks OL phase) were randomly allocated (1:1) to one of the two treatment groups (topiramate or placebo). The randomisation took place at Visit 6 (Week 26)

Timeline

• Start date: 2003-11-01
• Completion: 2006-08-01
• First posted: 2005-09-22
• Last updated: 2014-07-02

Locations

68 sites across 20 countries: Austria, Belgium, Bulgaria, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Norway, Poland, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Switzerland, Turkey (Türkiye), United Kingdom