The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis
NCT ID: NCT00917839
Last Updated: 2009-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
88 participants
INTERVENTIONAL
2009-06-30
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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lamotrigine
7 weeks initial phase with increasing dose beginning with 25 mg oral 12 months treatment phase with fixed dose of 100 mg oral
lamotrigine
100 mg, once daily, 12 months
Placebo
300mg Mannitol with 2% Aerosil
lamotrigine
100 mg, once daily, 12 months
Interventions
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lamotrigine
100 mg, once daily, 12 months
Eligibility Criteria
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Inclusion 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 Criteria
* 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
18 Years
50 Years
ALL
No
Sponsors
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Cantonal Hospital of St. Gallen
OTHER
Responsible Party
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Cantonal Hospital of St. Gallen
Locations
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Cantonal Hospital St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LT.01
Identifier Type: -
Identifier Source: org_study_id
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