The Prolonged Use of Topiramate for Preventing Migraine Headaches
CompletedPhase 3NCT00216619
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial to Investigate the Efficacy and Tolerability of Topiramate in Prolonged Migraine Prevention
- Conditions
- Interventions
- Drug: Topiramate
- Drug: Topiramate - Placebo
- Sponsor
- Janssen Pharmaceutica N.V., Belgium
- Start date
- 2003-11
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- Austria, Belgium, Bulgaria, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Norway, Poland, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Switzerland, Turkey (Türkiye), United Kingdom
- Total sites listed
- 68
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Established history of migraine for at least one year; * Migraine meets HIS (International Headache Society) criteria * An average of at least 4 monthly migraine days during the 3 months preceding trial entry * Capable of keeping trial records; Exclusion Criteria: * Patient used migraine prophylactic medication in the month prior to trial entry (flunarizine: 3 months prior to entry) * Patient had failed (lack of efficacy) more than two adequate previous regimens of migraine prophylactic medications * Patient had a history of severe drug allergy or hypersensitivity * Patient overused analgesics, opiates, ergots and/or triptans * Patient had been using topiramate regularly
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00216619