NCT00261326

Simvastatin Treatment of Patients With Acute Optic Neuritis

Simvastatin Treatment of Patients With Acut Optic Neuritis. A Doubleblind, Randomized and Placebo Controlled Fase III Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Glostrup University Hospital, Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Optic Neuritis
• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	simvastatin	80 mg once daily
DRUG	placebo	calcium tablets once daily

Timeline

• Start date: 2006-09-01
• Primary completion: 2010-01-01
• Completion: 2011-05-01
• First posted: 2005-12-05
• Last updated: 2011-01-10

Locations

1 site across 1 country: Denmark