Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Simvastatin Treatment of Patients With Acute Optic Neuritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Glostrup University Hospital, Copenhagen.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Alpharma ApS
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT00261326
First received: December 2, 2005
Last updated: January 7, 2011
Last verified: March 2009

December 2, 2005
January 7, 2011
September 2006
January 2010   (final data collection date for primary outcome measure)
The contrast sensibility of the eye after 3 months of the treatment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • The contrast sensitivity of the eye after 3 months of the treatment
  • Developing MS after 6 months
Complete list of historical versions of study NCT00261326 on ClinicalTrials.gov Archive Site
  • Visual acuity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • visual evokes potentials (VEP) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • cerebral MRI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Developing MS after 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Visual acuity,
  • visuel evokes potentials (VEP),
  • cerebral MRI
Not Provided
Not Provided
 
Simvastatin Treatment of Patients With Acute Optic Neuritis
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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Optic Neuritis
  • Multiple Sclerosis
  • Drug: simvastatin
    80 mg once daily
  • Drug: placebo
    calcium tablets once daily
  • Active Comparator: B
    simvastatin tablets 80 mg daily
    Intervention: Drug: simvastatin
  • Placebo Comparator: A
    calcium tablets 80 mg
    Intervention: Drug: placebo
Tsakiri A, Kallenbach K, Fuglø 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
64
May 2011
January 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 59 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00261326
Statin-01, KA 04068gs
Yes
MSci Jette Frederiksen, Glostrup Hospital
Glostrup University Hospital, Copenhagen
Alpharma ApS
Study Director: Jette L Frederiksen, Dr.Med
Glostrup University Hospital, Copenhagen
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP