Simvastatin Treatment of Patients With Acute Optic Neuritis

NCT ID: NCT00261326

Last Updated: 2011-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2011-05-31

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.

Conditions

Optic Neuritis; Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

B

simvastatin tablets 80 mg daily

Group Type: ACTIVE_COMPARATOR

simvastatin

Intervention Type: DRUG

80 mg once daily

A

calcium tablets 80 mg

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

calcium tablets once daily

Interventions

simvastatin

80 mg once daily

Intervention Type: DRUG

placebo

calcium tablets once daily

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alpharma ApS

INDUSTRY

Sponsor Role: collaborator

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Glostrup Hospital

Principal Investigators

Jette L Frederiksen, Dr.Med

Role: STUDY_DIRECTOR

Locations

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

Glostrup Municipality, Glostrup, Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 21921071 (View on PubMed)

Other Identifiers

KA 04068gs

Identifier Type: OTHER

Identifier Source: secondary_id

Statin-01

Identifier Type: -

Identifier Source: org_study_id