Simvastatin Treatment of Patients With Acut Optic Neuritis. A Doubleblind, Randomized and Placebo Controlled Fase III Trial
Overview
- Phase
- Phase 3
- Intervention
- simvastatin
- Conditions
- Optic Neuritis
- Sponsor
- Glostrup University Hospital, Copenhagen
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- The contrast sensibility of the eye after 3 months of the treatment
- Last Updated
- 15 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
- •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
- •Hyperthyroidism
- •Diabetes mellitus
Arms & Interventions
B
simvastatin tablets 80 mg daily
Intervention: simvastatin
A
calcium tablets 80 mg
Intervention: placebo
Outcomes
Primary Outcomes
The contrast sensibility of the eye after 3 months of the treatment
Time Frame: 6 months
Secondary Outcomes
- Visual acuity(6 months)
- visual evokes potentials (VEP)(6 months)
- cerebral MRI(6 months)
- Developing MS after 6 months(6 months)