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Sponsored by: |
Alpharma ApS |
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Information provided by: | Alpharma |
ClinicalTrials.gov Identifier: | NCT00261326 |
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 risc to develop multiple sclerosis (MS)
Condition | Intervention | Phase |
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Optic Neuritis Multiple Sclerosis |
Drug: simvastatin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | The Danish Ethics Committee |
Estimated Enrollment: | 64 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | January 2008 |
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.
Ages Eligible for Study: | 18 Years to 59 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jette L Frederiksen, Dr. Med | +45 43233041 | jefr@glostruphosp.kbhamt.dk |
Contact: Anna Tsakiri, MD | +45 27276423 | ants@dadlnet.dk |
Denmark | |
The clinic of the research for optic neuritis and MS, The Dpt. of Neurology at Glostrup Hospital | |
Glostrup, Denmark, DK-2600 |
Study Director: | Jette L Frederiksen, Dr.Med | Unaffiliated |
Study ID Numbers: | Statin-01, KA 04068gs |
Study First Received: | December 2, 2005 |
Last Updated: | December 2, 2005 |
ClinicalTrials.gov Identifier: | NCT00261326 |
Health Authority: | Denmark: Danish Medicines Agency |
Simvastatin Optic Neuritis Multiple Sclerosis |
Papillitis Autoimmune Diseases Demyelinating Diseases Simvastatin Eye Diseases Demyelinating diseases Sclerosis Optic nerve disorder |
Neuritis Multiple Sclerosis Neuromuscular Diseases Peripheral Nervous System Diseases Demyelinating Autoimmune Diseases, CNS Optic Nerve Diseases Autoimmune Diseases of the Nervous System Optic Neuritis |
Antimetabolites Pathologic Processes Molecular Mechanisms of Pharmacological Action Immune System Diseases Therapeutic Uses Antilipemic Agents |
Nervous System Diseases Enzyme Inhibitors Anticholesteremic Agents Cranial Nerve Diseases Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |