Simvastatin Treatment of Patients With Acute Optic Neuritis

Study Overview
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Brief Summary
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The purpose of this study is to investigate if the simvastatin treatment improve the visual function after 3 months of the inclusion to this project and if the simvastatin influences the results on cerebral MRI after 3 and 6 months of the inclusion. In addition the development of new demyelinating relapses. In the patients with monosymptomatic acut optic neuritis to investigate whether the simvastatin reduces the risk to develop multiple sclerosis (MS).

Detailed Description
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Multiple Sclerosis (MS) is a chronic inflammatory demyelinating disease in the Central Nervous System (CNS). Acute optic neuritis is a common symptom of MS and is considered to have the same pathogenesis as MS, where autoimmune and inflammatory mechanisms lead to the progression of MS. Statins reduce the cholesterol in blood and in addition have anti-inflammatory effects. From experimental data and results from pilot projects there is evidence that the statins perform anti-inflammatory and immune-modulatory effects and one can expect a beneficial outcome in the autoimmune inflammatory diseases after the treatment with statins.

Official Title
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Simvastatin Treatment of Patients With Acut Optic Neuritis. A Doubleblind, Randomized and Placebo Controlled Fase III Trial

Conditions
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Optic Neuritis, Multiple Sclerosis

Intervention / Treatment
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* Drug: simvastatin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute Optic Neuritis Abnormal contrast sensitivity score (>80) Symptom duration maximum 4 weeks Men and women between 18 and 59 years old The patient must be physical and mental able to participate i this project with a 6 months of the duration The patient must sign the written consent of the participation before the inclusion. Exclusion Criteria: Optic neuritis earlier in the same eye Pregnancy Nursing Fertile women who do not use contraception Women who contemplate pregnancy in the duration of the study Steroid treatment the last 4 weeks before the inclusion Immune-supressor treatment the last 6 months before the inclusion Active liver disease or continuous increase of liver enzymes (ASAT, ALAT)without known reason. Kidney failure Myopathy Hyperthyroidism Diabetes mellitus Alcoholism Fibrates intake Statin treatment for other disease Simultaneous participation in other studies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: B<br>simvastatin tablets 80 mg daily | Drug: simvastatin<br>* 80 mg once daily<br>|
| Placebo Comparator: A<br>calcium tablets 80 mg | Drug: placebo<br>* calcium tablets once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The contrast sensibility of the eye after 3 months of the treatment |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | 6 months | 
| visual evokes potentials (VEP) |  | 6 months | 
| cerebral MRI |  | 6 months | 
| Developing MS after 6 months |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Simvastatin, Optic Neuritis, Multiple Sclerosis