Simvastatin Treatment of Patients With Acute Optic Neuritis

Glostrup University Hospital, Copenhagen64 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Optic Neuritis Multiple Sclerosis

Interventions

simvastatinDRUG

80 mg once daily

placeboDRUG

calcium tablets once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 59 Years

Medical Language ↔ Plain English

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.

Locations (1)

The clinic of the research for optic neuritis and MS, The Dpt. of Neurology at Glostrup Hospital

Glostrup Municipality, Glostrup, Denmark

Outcomes

Primary Outcomes

The contrast sensibility of the eye after 3 months of the treatment

Time frame: 6 months

Secondary Outcomes

Visual acuity

Time frame: 6 months

visual evokes potentials (VEP)

Time frame: 6 months

cerebral MRI

Time frame: 6 months

Developing MS after 6 months

Time frame: 6 months

Data from ClinicalTrials.gov

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