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

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cantonal Hospital of St. Gallen
• Treatments: Anticonvulsants; Interferon beta-1a; Interferon-beta; Interferons; Lamotrigine; Neuroprotective Agents

Criteria

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