Clinical trial NCT00261326: Simvastatin Treatment of Patients With Acute Optic Neuritis
Official title: Simvastatin Treatment of Patients With Acut Optic Neuritis. A Doubleblind, Randomized and Placebo Controlled Fase III Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Optic Neuritis
Multiple Sclerosis
Keywords: Simvastatin
Optic Neuritis
Multiple Sclerosis
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: Alpharma ApS
First posted: 2005-12-05
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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.

Primary outcomes:
measure: The contrast sensibility of the eye after 3 months of the treatment
timeFrame: 6 months
Secondary outcomes:
measure: Visual acuity
timeFrame: 6 months
measure: visual evokes potentials (VEP)
timeFrame: 6 months
measure: cerebral MRI
timeFrame: 6 months
measure: Developing MS after 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: The clinic of the research for optic neuritis and MS, The Dpt. of Neurology at Glostrup Hospital
Study officials:
name: Jette L Frederiksen, Dr.Med
role: STUDY_DIRECTOR
References:
citation: Tsakiri A, Kallenbach K, Fuglo D, Wanscher B, Larsson H, Frederiksen J. Simvastatin improves final visual outcome in acute optic neuritis: a randomized study. Mult Scler. 2012 Jan;18(1):72-81. doi: 10.1177/1352458511415452. Epub 2011 Sep 15.