Status:
UNKNOWN
Simvastatin Treatment of Patients With Acute Optic Neuritis
Lead Sponsor:
Glostrup University Hospital, Copenhagen
Collaborating Sponsors:
Alpharma ApS
Conditions:
Optic Neuritis
Multiple Sclerosis
Eligibility:
All Genders
18-59 years
Phase:
PHASE3
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 ce...
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 pathogene...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2011
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00261326
Start Date
September 1 2006
End Date
May 1 2011
Last Update
January 10 2011
Active Locations (1)
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1
The clinic of the research for optic neuritis and MS, The Dpt. of Neurology at Glostrup Hospital
Glostrup Municipality, Glostrup, Denmark, DK-2600