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 risc to develop multiple sclerosis (MS)

Condition	Intervention	Phase
Optic Neuritis Multiple Sclerosis	Drug: simvastatin	Phase III

Further study details as provided by Alpharma ApS:

Primary Outcomes: The contrast sensitivity of the eye after 3 months of the treatment; Developing MS after 6 months
Secondary Outcomes: Visual acuity,; visuel evokes potentials (VEP),; cerebral MRI
Expected Total Enrollment:  64

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.

Ages Eligible for Study:  18 Years   -   59 Years,  Genders Eligible for Study:  Both

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:

• Opticus neuritis earlier in the same eye
• Pregnacy
• Nursing
• Fertile women who do not use contraception
• Whomen who contemplate pregnancy in the duration of the study
• Steroide treatment the last 4 weeks before the inclusion
• Immune-supressor treatment the last 6 måneder before the inclusion
• Active liver disease or continous increase of liver enzymes (ASAT, ALAT)without known reason.
• Kidney failure
• Myopathy
• Hyperthyreoidism
• Diabetes melitus
• Alcoholism
• Fibrates intake
• Statin treatmen for other disease
• Simultaneous participation in other studies.

Please refer to this study by ClinicalTrials.gov identifier  NCT00261326

Jette L Frederiksen, Dr. Med      +45 43233041    jefr@glostruphosp.kbhamt.dk
Anna Tsakiri, MD      +45 27276423    ants@dadlnet.dk

Denmark
      The clinic of the research for optic neuritis and MS, The Dpt. of Neurology at Glostrup Hospital, Glostrup,  DK-2600,  Denmark

Study chairs or principal investigators

Jette L Frederiksen, Dr.Med,  Study Director,  Unaffiliated   

Study ID Numbers:  Statin-01; KA 04068gs
Last Updated:  December 8, 2005
Record first received:  December 2, 2005
ClinicalTrials.gov Identifier:  NCT00261326
Health Authority: Denmark: Danish Medicines Agency
ClinicalTrials.gov processed this record on 2006-01-10