Multiple Sclerosis Clinical Trial
Official title:
Simvastatin Treatment of Patients With Acut Optic Neuritis. A Doubleblind, Randomized and Placebo Controlled Fase III Trial
Verified date | March 2009 |
Source | Glostrup University Hospital, Copenhagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
Country | Name | City | State |
---|---|---|---|
Denmark | The clinic of the research for optic neuritis and MS, The Dpt. of Neurology at Glostrup Hospital | Glostrup |
Lead Sponsor | Collaborator |
---|---|
Glostrup University Hospital, Copenhagen | Alpharma ApS |
Denmark,
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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