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

Cantonal Hospital of St. Gallen

Status and phase: Unknown; Phase 2

Conditions: Relapsing-Remitting Multiple Sclerosis

Treatments: Drug: lamotrigine

Study type: Interventional

Funder types: Other

Identifiers

NCT00917839

LT.01

Details and patient eligibility

About

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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 2 patient groups, including a placebo group

lamotrigine

Experimental group

Description:

7 weeks initial phase with increasing dose beginning with 25 mg oral 12 months treatment phase with fixed dose of 100 mg oral

Treatment:

Drug: lamotrigine

Placebo

Placebo Comparator group

Description:

300mg Mannitol with 2% Aerosil

Treatment:

Drug: lamotrigine