Simvastatin Treatment of Patients With Acute Optic Neuritis

January 7, 2011 updated by: Glostrup University Hospital, Copenhagen

Simvastatin Treatment of Patients With Acut Optic Neuritis. A Doubleblind, Randomized and Placebo Controlled Fase III Trial

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).

Study Overview

Status

Unknown

Intervention / Treatment

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

Enrollment (Anticipated)

64

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B
simvastatin tablets 80 mg daily
80 mg once daily
Placebo Comparator: A
calcium tablets 80 mg
calcium tablets once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The contrast sensibility of the eye after 3 months of the treatment
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual acuity
Time Frame: 6 months
6 months
visual evokes potentials (VEP)
Time Frame: 6 months
6 months
cerebral MRI
Time Frame: 6 months
6 months
Developing MS after 6 months
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: Jette L Frederiksen, Dr.Med

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Anticipated)

January 1, 2010

Study Completion (Anticipated)

May 1, 2011

Study Registration Dates

First Submitted

December 2, 2005

First Submitted That Met QC Criteria

December 2, 2005

First Posted (Estimate)

December 5, 2005

Study Record Updates

Last Update Posted (Estimate)

January 10, 2011

Last Update Submitted That Met QC Criteria

January 7, 2011

Last Verified

March 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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