The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis

Randomized, Placebo-Controlled Phase II Monocentric Trial for the Neuroprotective Effect of Lamotrigine Plus Interferon Beta 1a 30mcg Once Weekly Intramuscular in Patients With Relapsing-Remitting Multiple Sclerosis.

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.

Inclusion Criteria:

• 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 Criteria:

• 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