Status unknownPhase 3MS (type not specified)NCT00261326

What it found

Missed its main goal

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

    Vision
  • visual evokes potentials (VEP)

    6 months

    Myelin repair
  • cerebral MRI

    6 months

    MRI lesions
  • Developing 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

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History

    1. Started

      Sept 2006

    2. Main results due

      Jan 2010

    3. Finished

      May 2011

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