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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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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