Status:
UNKNOWN
The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis
Lead Sponsor:
Cantonal Hospital of St. Gallen
Conditions:
Relapsing-Remitting Multiple Sclerosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
This study is designed to evaluate the neuroprotective effect of lamotrigine in the combination of interferon beta 1a once weekly intramuscular in patients with relapsing-remitting multiple sclerosis.
Eligibility Criteria
Inclusion
- definitive multiple sclerosis according to Mc Donald criteria
- clinical isolated syndrome according to Mc Donald criteria
- Expanded Disability Status Scale Score 0-5
- Pre-treatment with interferon beta 1a (Avonex) since at least 2 months before inclusion
Exclusion
- relapse within 30 days prior to randomisation
- steroid pulse therapy within 30 days prior to randomisation
- pregnancy or poor contraception
- contraindication for lamotrigine
- depressive symptoms
- drugs with possible interaction with lamotrigine according to instruction leaflet
- other medical relevant conditions but multiple sclerosis
- clinically relevant laboratory results
- contraindication for MRI
- missing informed consent
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00917839
Start Date
June 1 2009
End Date
December 1 2011
Last Update
June 10 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cantonal Hospital St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland, 9007