The Prolonged Use of Topiramate for Preventing Migraine Headaches

Condition(s) targeted: Migraine

Intervention: Topiramate (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Janssen Pharmaceutica N.V., Belgium

Official(s) and/or principal investigator(s):
Janssen Pharmaceutica N.V., Belgium Clinical Trial, Study Director, Affiliation: Janssen Pharmaceutica N.V., Belgium

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

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change in migraine days compared between the topiramate group and placebo group at the last 4 weeks of the open-label phase and the final 4 weeks of the placebo-controlled phase

Secondary outcome: Health related quality of life as recorded in patient questionnaires (MIDAS, HIT-6, SF-12); safety and tolerability measures

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 miligrams of topirimate per day and will be increased 25 milgrams per day once weekly and then raised to either the target--100 miligrams per day--or the maximum dose that is well tolerated up to 200 miligrams 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 miligrams 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 miligrams to 100 miligrams daily by mouth; increased by 25 miligrams per day once weekly; dose cannot exceed 200 miligrams per day and must be stable for the last 4 weeks.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: - History of migraine for >= 1 year - migraine meets HIS

(International Headache Society) criteria - average of >= 4 migraine days per month in the

3 months preceding trial entry - ability to keep trial records

Exclusion Criteria: - Use of migraine prevention medicine in the month prior to trial entry

(use of flunarizine in the 3 months prior to entry) - migraine was not relieved by >2

adequate prior regimens of migraine prevention medicines - use of disallowed concomitant

therapy - overuse of analgesics, opioids, ergots and/or triptans - regular use of

topiramate for >2 weeks.

To learn how to participate in this trial please click here.

Starting date: November 2003
Last updated: September 13, 2005