Simvastatin Treatment of Patients With Acute Optic Neuritis. - Full Text View

Sponsored by:	Alpharma ApS
Information provided by:	Alpharma
ClinicalTrials.gov Identifier:	NCT00261326

Purpose

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
Optic Neuritis Multiple Sclerosis	Drug: simvastatin	Phase III

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Simvastatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	The Danish Ethics Committee

Further study details as provided by Alpharma:

Primary Outcome Measures:

The contrast sensitivity of the eye after 3 months of the treatment
Developing MS after 6 months

Secondary Outcome Measures:

Visual acuity,
visuel evokes potentials (VEP),
cerebral MRI

Estimated Enrollment:	64
Study Start Date:	January 2006
Estimated Study Completion Date:	January 2008

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.

Eligibility

Ages Eligible for Study:	18 Years to 59 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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:

Opticus neuritis earlier in the same eye
Pregnacy
Nursing
Fertile women who do not use contraception
Whomen who contemplate pregnancy in the duration of the study
Steroide treatment the last 4 weeks before the inclusion
Immune-supressor treatment the last 6 måneder before the inclusion
Active liver disease or continous increase of liver enzymes (ASAT, ALAT)without known reason.
Kidney failure
Myopathy
Hyperthyreoidism
Diabetes melitus
Alcoholism
Fibrates intake
Statin treatmen for other disease
Simultaneous participation in other studies.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00261326

Contacts

Contact: Jette L Frederiksen, Dr. Med	+45 43233041	jefr@glostruphosp.kbhamt.dk
Contact: Anna Tsakiri, MD	+45 27276423	ants@dadlnet.dk

Locations

Denmark
The clinic of the research for optic neuritis and MS, The Dpt. of Neurology at Glostrup Hospital
Glostrup, Denmark, DK-2600

Sponsors and Collaborators

Alpharma ApS

Investigators

Study Director:

Jette L Frederiksen, Dr.Med

Unaffiliated

More Information

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

Keywords provided by Alpharma:

Simvastatin
Optic Neuritis
Multiple Sclerosis

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 14, 2009