Multiple Sclerosis, Optic Neuritis
Conditions
Keywords
Simvastatin, Optic Neuritis, Multiple Sclerosis
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.
Interventions
DRUGsimvastatin
80 mg once daily
DRUGplacebo
calcium tablets once daily
Sponsors
Alpharma ApS
Glostrup University Hospital, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The contrast sensibility of the eye after 3 months of the treatment | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Visual acuity | 6 months |
| visual evokes potentials (VEP) | 6 months |
| cerebral MRI | 6 months |
| Developing MS after 6 months | 6 months |
Countries
Denmark
Outcome results
None listed