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Simvastatin Treatment of Patients With Acute Optic Neuritis

Primary Purpose

Optic Neuritis, Multiple Sclerosis

Status
Unknown status
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
simvastatin
placebo
Sponsored by
Glostrup University Hospital, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Optic Neuritis focused on measuring Simvastatin, Optic Neuritis, Multiple Sclerosis

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

B

A

Arm Description

simvastatin tablets 80 mg daily

calcium tablets 80 mg

Outcomes

Primary Outcome Measures

The contrast sensibility of the eye after 3 months of the treatment

Secondary Outcome Measures

Visual acuity
visual evokes potentials (VEP)
cerebral MRI
Developing MS after 6 months

Full Information

First Posted
December 2, 2005
Last Updated
January 7, 2011
Sponsor
Glostrup University Hospital, Copenhagen
Collaborators
Alpharma ApS
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1. Study Identification

Unique Protocol Identification Number
NCT00261326
Brief Title
Simvastatin Treatment of Patients With Acute Optic Neuritis
Official Title
Simvastatin Treatment of Patients With Acut Optic Neuritis. A Doubleblind, Randomized and Placebo Controlled Fase III Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2006 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
May 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Glostrup University Hospital, Copenhagen
Collaborators
Alpharma ApS

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optic Neuritis, Multiple Sclerosis
Keywords
Simvastatin, Optic Neuritis, Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
B
Arm Type
Active Comparator
Arm Description
simvastatin tablets 80 mg daily
Arm Title
A
Arm Type
Placebo Comparator
Arm Description
calcium tablets 80 mg
Intervention Type
Drug
Intervention Name(s)
simvastatin
Intervention Description
80 mg once daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
calcium tablets once daily
Primary Outcome Measure Information:
Title
The contrast sensibility of the eye after 3 months of the treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Visual acuity
Time Frame
6 months
Title
visual evokes potentials (VEP)
Time Frame
6 months
Title
cerebral MRI
Time Frame
6 months
Title
Developing MS after 6 months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jette L Frederiksen, Dr.Med
Official's Role
Study Director
Facility Information:
Facility Name
The clinic of the research for optic neuritis and MS, The Dpt. of Neurology at Glostrup Hospital
City
Glostrup
ZIP/Postal Code
DK-2600
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
21921071
Citation
Tsakiri A, Kallenbach K, Fuglo D, Wanscher B, Larsson H, Frederiksen J. Simvastatin improves final visual outcome in acute optic neuritis: a randomized study. Mult Scler. 2012 Jan;18(1):72-81. doi: 10.1177/1352458511415452. Epub 2011 Sep 15.
Results Reference
derived

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Simvastatin Treatment of Patients With Acute Optic Neuritis

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