Simvastatin Treatment of Patients With Acute Optic Neuritis

• Status: Unknown status
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glostrup University Hospital, Copenhagen
• Collaborator: Alpharma ApS
• Treatments: Simvastatin

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

• 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.