The Prolonged Use of Topiramate for Preventing Migraine Headaches - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

August 10, 2009

Start Date ^ICMJE

November 2003

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00216619 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

The Prolonged Use of Topiramate for Preventing Migraine Headaches

Official Title ^ICMJE

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

Brief 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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Migraine

Intervention ^ICMJE

Drug: Topiramate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

834

Completion Date

August 2006

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00216619

Responsible Party

Study ID Numbers ^ICMJE

CR003931

Study Sponsor ^ICMJE

Janssen Pharmaceutica N.V., Belgium

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Janssen Pharmaceutica N.V. Clinical Trial

Janssen Pharmaceutica N.V.

Information Provided By

Janssen Pharmaceutica N.V., Belgium

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP