This trial is active, not recruiting.

Conditions optic neuritis, multiple sclerosis
Treatments simvastatin, placebo
Phase phase 3
Sponsor Glostrup University Hospital, Copenhagen
Collaborator Alpharma ApS
Start date September 2006
End date January 2010
Trial size 64 participants
Trial identifier NCT00261326, KA 04068gs, Statin-01


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
(Active Comparator)
simvastatin tablets 80 mg daily
80 mg once daily
(Placebo Comparator)
calcium tablets 80 mg
calcium tablets once daily

Primary Outcomes

The contrast sensibility of the eye after 3 months of the treatment
time frame: 6 months

Secondary Outcomes

Visual acuity
time frame: 6 months
visual evokes potentials (VEP)
time frame: 6 months
cerebral MRI
time frame: 6 months
Developing MS after 6 months
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 59 years old.

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.

Additional Information

Official title Simvastatin Treatment of Patients With Acut Optic Neuritis. A Doubleblind, Randomized and Placebo Controlled Fase III Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2011.
Information provided to ClinicalTrials.gov by Glostrup University Hospital, Copenhagen.