Simvastatin Treatment of Patients With Acute Optic Neuritis
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).
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 Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Optic Neuritis
Intervention
simvastatin, placebo
Location
The clinic of the research for optic neuritis and MS, The Dpt. of Neurology at Glostrup Hospital
Glostrup
Denmark
DK-2600
Status
Active, not recruiting
Source
Glostrup University Hospital, Copenhagen
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00261326
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Optic Neuritis
Inflammation of the optic nerve. Commonly associated conditions include autoimmune disorders such as MULTIPLE SCLEROSIS, infections, and granulomatous diseases. Clinical features include retro-orbital pain that is aggravated by eye movement, loss of color vision, and contrast sensitivity that may progress to severe visual loss, an afferent pupillary defect (Marcus-Gunn pupil), and in some instances optic disc hyperemia and swelling. Inflammation may occur in the portion of the nerve within the globe (neuropapillitis or anterior optic neuritis) or the portion behind the globe (retrobulbar neuritis or posterior optic neuritis).
Neuromyelitis Optica
A syndrome characterized by acute OPTIC NEURITIS in combination with acute MYELITIS, TRANSVERSE. Demyelinating and/or necrotizing lesions form in one or both optic nerves and in the spinal cord. The onset of optic neuritis and myelitis may be simultaneous or separated by several months. (J Neurol Neurosurg Psychiatry 1996 Apr;60(4):382-387)
Optic Atrophy
Atrophy of the optic disk which may be congenital or acquired. This condition indicates a deficiency in the number of nerve fibers which arise in the RETINA and converge to form the OPTIC DISK; OPTIC NERVE; OPTIC CHIASM; and optic tracts. GLAUCOMA; ISCHEMIA; inflammation, a chronic elevation of intracranial pressure, toxins, optic nerve compression, and inherited conditions (see OPTIC ATROPHIES, HEREDITARY) are relatively common causes of this condition.
Absinthe
An extract of absinthium and other bitter herbs, containing 60% alcohol. Prolonged ingestion causes nervousness, convulsions, trismus, amblyopia, optic neuritis, and mental deterioration. (Dorland, 27th ed)
Multiple Sclerosis, Relapsing-remitting
The most common clinical variant of MULTIPLE SCLEROSIS, characterized by recurrent acute exacerbations of neurologic dysfunction followed by partial or complete recovery. Common clinical manifestations include loss of visual (see OPTIC NEURITIS), motor, sensory, or bladder function. Acute episodes of demyelination may occur at any site in the central nervous system, and commonly involve the optic nerves, spinal cord, brain stem, and cerebellum. (Adams et al., Principles of Neurology, 6th ed, pp903-914)
Clinical Trials
Optic Neuritis Treatment Trial (ONTT)
To assess the beneficial and adverse effects of corticosteroid treatment for optic neuritis. To determine the natural history of vision in patients who suffer optic neuritis. To identify...
Longitudinal Optic Neuritis Study (LONS)
To assess the beneficial and adverse effects of corticosteroid treatment for optic neuritis. To determine the natural history of vision in patients who suffer optic neuritis. To identify...
Intravenous Immunoglobulin Therapy in Optic Neuritis
To determine whether high-dose intravenous immunoglobulin (IVIg) is more effective than placebo in restoring lost visual function (visual acuity) in optic neuritis (ON). To determine the...
Atacicept in Optic Neuritis, Phase II
This study is intended to evaluate the evaluate safety and tolerability of atacicept compared to placebo and to explore the neuroprotective effect of atacicept as assessed by Optical Coher...
The main objective of the study is to determine whether GA 20mg SC once daily reduces the amount of axonal loss in the optic nerve (measured by RFNL thickness) after a first event of AON c...
PubMed Articles
Sustained motion perception deficit following optic neuritis: Behavioral and cortical evidence.
To assess the recovery process in patients after an acute optic neuritis (ON) attack, comparing static and dynamic visual functions.
Focal macular photopic negative response in patients with optic neuritis.
PurposeTo investigate, by focal macular electroretinography (ERG), the change of photopic negative response (PhNR) in the recovery of visual function in patients with optic neuritis.MethodsFocal macul...
Clinical characteristics of optic neuritis in Taiwanese children.
PurposeTo document the etiology, clinical presentation, and visual prognosis of optic neuritis in Taiwanese children.MethodsRetrospectively reviewed children younger than 18 years old with optic neuri...
Optic Neuritis Associated with Adalimumab in the Treatment of Uveitis.
Background: Tumor necrosis factor (TNF) inhibitors such as adalimumab are increasingly used in the treatment of ocular inflammatory disease refractory to standard therapies. There is evidence that TNF...
Neuromyelitis optica in Japanese sisters.
We report cases of Japanese sisters with neuromyelitis optica (NMO). The elder sister was 25, when she was diagnosed with right optic neuritis. After 3 months, she developed left optic neuritis and my...
