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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
  Purpose

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 Intervention Phase
Optic Neuritis
Multiple Sclerosis
Drug: simvastatin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Simvastatin Treatment of Patients With Acut Optic Neuritis. A Doubleblind, Randomized and Placebo Controlled Fase III Trial

Resource links provided by NLM:


Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • The contrast sensibility of the eye after 3 months of the treatment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 64
Study Start Date: September 2006
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Glostrup University Hospital, Copenhagen

Additional 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
Study First Received: December 2, 2005
Last Updated: January 7, 2011
Health Authority: Denmark: Danish Medicines Agency

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

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

ClinicalTrials.gov processed this record on November 25, 2014