- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00261326
Simvastatin Treatment of Patients With Acute Optic Neuritis
Simvastatin Treatment of Patients With Acut Optic Neuritis. A Doubleblind, Randomized and Placebo Controlled Fase III Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Glostrup, Denmark, DK-2600
- The clinic of the research for optic neuritis and MS, The Dpt. of Neurology at Glostrup Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: B
simvastatin tablets 80 mg daily
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80 mg once daily
|
Placebo Comparator: A
calcium tablets 80 mg
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calcium tablets once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The contrast sensibility of the eye after 3 months of the treatment
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual acuity
Time Frame: 6 months
|
6 months
|
visual evokes potentials (VEP)
Time Frame: 6 months
|
6 months
|
cerebral MRI
Time Frame: 6 months
|
6 months
|
Developing MS after 6 months
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Jette L Frederiksen, Dr.Med
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Eye Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Optic Nerve Diseases
- Cranial Nerve Diseases
- Multiple Sclerosis
- Sclerosis
- Neuritis
- Optic Neuritis
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Simvastatin
Other Study ID Numbers
- Statin-01
- KA 04068gs (Other Identifier: Regional scientific ethics Committe)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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