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Simvastatin Treatment of Patients With Acute Optic Neuritis

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ClinicalTrials.gov Identifier: NCT00261326
Recruitment Status : Unknown
Verified March 2009 by Glostrup University Hospital, Copenhagen.
Recruitment status was:  Active, not recruiting
First Posted : December 5, 2005
Last Update Posted : January 10, 2011
Sponsor:
Collaborator:
Alpharma ApS
Information provided by:
Glostrup University Hospital, Copenhagen

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).

Condition or disease Intervention/treatment Phase
Optic Neuritis Multiple Sclerosis Drug: simvastatin Drug: placebo Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Simvastatin Treatment of Patients With Acut Optic Neuritis. A Doubleblind, Randomized and Placebo Controlled Fase III Trial
Study Start Date : September 2006
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: B
simvastatin tablets 80 mg daily
Drug: simvastatin
80 mg once daily
Placebo Comparator: A
calcium tablets 80 mg
Drug: placebo
calcium tablets once daily



Primary Outcome Measures :
  1. The contrast sensibility of the eye after 3 months of the treatment [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Visual acuity [ Time Frame: 6 months ]
  2. visual evokes potentials (VEP) [ Time Frame: 6 months ]
  3. cerebral MRI [ Time Frame: 6 months ]
  4. Developing MS after 6 months [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00261326


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
Glostrup University Hospital, Copenhagen
Alpharma ApS
Investigators
Study Director: Jette L Frederiksen, Dr.Med

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MSci Jette Frederiksen, Glostrup Hospital
ClinicalTrials.gov Identifier: NCT00261326     History of Changes
Other Study ID Numbers: Statin-01
KA 04068gs ( Other Identifier: Regional scientific ethics Committe )
First Posted: December 5, 2005    Key Record Dates
Last Update Posted: January 10, 2011
Last Verified: March 2009

Keywords provided by Glostrup University Hospital, Copenhagen:
Simvastatin
Optic Neuritis
Multiple Sclerosis

Additional relevant MeSH terms:
Optic Neuritis
Sclerosis
Multiple Sclerosis
Neuritis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors