Clinical Trial: Simvastatin Treatment of Patients With Acute Optic Neuritis

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Glostrup University Hospital, Copenhagen

Current Primary Outcome: The contrast sensibility of the eye after 3 months of the treatment [ Time Frame: 6 months ]

Original Primary Outcome:

  • The contrast sensitivity of the eye after 3 months of the treatment
  • Developing MS after 6 months


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Visual acuity,
  • visuel evokes potentials (VEP),
  • cerebral MRI


Information By: Glostrup University Hospital, Copenhagen

Dates:
Date Received: December 2, 2005
Date Started: September 2006
Date Completion: May 2011
Last Updated: January 7, 2011
Last Verified: March 2009