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

Phase 2

• Conditions: Relapsing-Remitting Multiple Sclerosis
• Interventions: Drug: lamotrigine

• Registration Number: NCT00917839
• Lead Sponsor: Cantonal Hospital of St. Gallen

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-06
• Study Start: 2009-06
• Study First Submitted: 2009-06-09
• Study First Submitted QC: 2009-06-09
• Last Update Submitted: 2009-06-09
• Study First Posted: 2009-06-10
• Last Update Posted: 2009-06-10
• Primary Completion: 2010-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lamotrigine	lamotrigine	7 weeks initial phase with increasing dose beginning with 25 mg oral 12 months treatment phase with fixed dose of 100 mg oral
Placebo	lamotrigine	300mg Mannitol with 2% Aerosil

Primary Outcome Measures

Name	Time	Method
N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy	12 months
Safety of lamotrigine in combination with interferon beta 1a (30 mcg) once weekly intramuscular.	6 months, 12 months

Secondary Outcome Measures

Name	Time	Method
relapse rate	12 months
Expanded disability status score	12 months
Fatigue Severity Score	12 months
N-Acetyl-Aspartate / creatine - quotient in normal appearing white matter by MR-spectroscopy	6 months

Trial Locations

Locations (1)

Cantonal Hospital St. Gallen; 🇨🇭 St. Gallen, Switzerland