Status:
COMPLETED
The Prolonged Use of Topiramate for Preventing Migraine Headaches
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Migraine
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 pe...
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 per...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
834 Patients enrolled
Trial Details
Trial ID
NCT00216619
Start Date
November 1 2003
End Date
August 1 2006
Last Update
July 2 2014
Active Locations (68)
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1
Innsbruck, Austria
2
Linz, Austria
3
Antwerp, Belgium
4
Charleroi, Belgium