Simvastatin Treatment of Patients With Acute Optic Neuritis
What it found
The main measure did not show a significant benefit.
“Simvastatin had a beneficial effect on VEP in both latency (p = 0.01) and amplitude (p = 0.01), a borderline effect on the Arden score (p = 0.06) and VAS (p = 0.04), and no effect on brain MRI or on relapse rate between the groups.”Read by software from the paper's abstract
Contrast sensitivity (Arden plates) · day 90 and day 180
p = 0.06 (Arden score)
Read by software from the paper's abstract
What was tested
Treatment tested
- Simvastatin
HMG-CoA reductase inhibitor
Placebo or sham
- placebo
What it measured
Main measures
The contrast sensibility of the eye after 3 months of the treatment
6 months
Other measures (4)
Visual acuity
6 months
Visionvisual evokes potentials (VEP)
6 months
Myelin repaircerebral MRI
6 months
MRI lesionsDeveloping MS after 6 months
6 months
Who could take part
MS (type not specified) · 18 to 59
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
Papers
Results
Tsakiri A, Kallenbach K, Fuglo D, Wanscher B, Larsson H, Frederiksen J. Simvastatin improves final visual outcome in acute optic neuritis: a randomized study. Mult Scler. 2012 Jan;18(1):72-81. doi: 10.1177/1352458511415452. Epub 2011 Sep 15.Simvastatin had a beneficial effect on VEP in both latency (p = 0.01) and amplitude (p = 0.01), a borderline effect on the Arden score (p = 0.06) and VAS (p = 0.04), and no effect on brain MRI or on relapse rate between the groups.
Read by software from the paper's abstract
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History
Started
Sept 2006
Main results due
Jan 2010
Finished
May 2011
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