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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Relapsing-Remitting Multiple Sclerosis

Intervention / Treatment
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* Drug: lamotrigine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lamotrigine<br>7 weeks initial phase with increasing dose beginning with 25 mg oral 12 months treatment phase with fixed dose of 100 mg oral | Drug: lamotrigine<br>* 100 mg, once daily, 12 months<br>|
| Placebo Comparator: Placebo<br>300mg Mannitol with 2% Aerosil | Drug: lamotrigine<br>* 100 mg, once daily, 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuroprotection, multiple sclerosis, brain atrophy, mr-spectroscopy