Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261326
Status:
UNKNOWN
Last Update Posted:
2011-01-10
First Post:
2005-12-02
Brief Title:
Simvastatin Treatment of Patients With Acute Optic Neuritis
Sponsor:
Glostrup University Hospital Copenhagen
Organization:
Glostrup University Hospital Copenhagen
Study Overview
Official Title:
Simvastatin Treatment of Patients With Acut Optic Neuritis A Doubleblind Randomized and Placebo Controlled Fase III Trial
Status:
UNKNOWN
Status Verified Date:
2009-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KA 04068gs | OTHER | Regional scientific ethics Committe | None |