Simvastatin Treatment of Patients With Acute Optic Neuritis

Glostrup University Hospital, Copenhagen

Status and phase: Unknown; Phase 3

Conditions: Multiple Sclerosis; Optic Neuritis

Treatments: Drug: simvastatin; Drug: placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00261326

KA 04068gs (Other Identifier)

Statin-01

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups, including a placebo group

B

Active Comparator group

Description:

simvastatin tablets 80 mg daily

Treatment:

Drug: simvastatin

A

Placebo Comparator group

Description:

calcium tablets 80 mg

Treatment:

Drug: placebo