Status:
COMPLETED
An Open-label Study to Evaluate Topiramate Therapy in Migraine Patients, and Its Effects on Subject Responsiveness to Migraine Treatment With Triptans
Lead Sponsor:
Janssen-Ortho Inc., Canada
Conditions:
Headache
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate whether prophylactic use of topiramate (preventative use before a migraine attack) enhances the effectiveness of migraine treatment with triptans.
Detailed Description
The objective of this pilot study is to determine if patients with migraine are more responsive to triptans taken for symptomatic headache treatment while on topiramate prophylactic therapy as compare...
Eligibility Criteria
Inclusion
- Subjects must have an established history consistent with migraine, with or without aura, confirming to International Headache Society (HIS) criteria for at least 6 months prior to study entry
- must be using a stable dose of triptan for migraine treatment for at least 3 migraine attacks per month
- must have failed \<=2 previous prophylactic medications due to lack of effectiveness
- must have had between 3 and 12 migraine periods and no more than 18 headache days (migraine and non-migraine) during the 6-week Prospective Baseline Period. (A headache day is defined as a calendar day which the subject experienced headache pain for at least 4 hours untreated, or 30 minutes duration treated)
- female subjects who are postmenopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control, and must have a negative pregnancy test at Visit 1.
Exclusion
- Subjects with headaches other than migraine with and/or without aura
- onset of migraine after age 50
- overuse analgesics or specific medications for treatment of migraine attacks
- currently on a prophylactic medication for migraine
- history of an unstable medical condition within the past 2 years, malignancy within the past 5 years, major psychiatric disorder within the past 6 months, suicidal ideations or suicide attempt within the past 2 years or history of alcohol or drug abuse within the past 6 months
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2004
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00261469
Start Date
April 1 2003
End Date
November 1 2004
Last Update
May 17 2011
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