Simvastatin Treatment of Patients With Acute Optic Neuritis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00261326
• Other study ID #: Statin-01
• Secondary ID: KA 04068gs
• Status: Unknown status
• Phase: Phase 3
• First received: December 2, 2005
• Last updated: January 7, 2011
• Start date: September 2006
• Est. completion date: May 2011

Study information

• Verified date: March 2009
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 64
• Est. completion date: May 2011
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Neuritis
• Optic Neuritis
• Sclerosis

Intervention

Drug:
• simvastatin
80 mg once daily
• placebo
calcium tablets once daily

Locations

Country	Name	City	State
Denmark	The clinic of the research for optic neuritis and MS, The Dpt. of Neurology at Glostrup Hospital	Glostrup

Sponsors (2)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen	Alpharma ApS

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The contrast sensibility of the eye after 3 months of the treatment		6 months
Secondary	Visual acuity		6 months
Secondary	visual evokes potentials (VEP)		6 months
Secondary	cerebral MRI		6 months
Secondary	Developing MS after 6 months		6 months