NCT00261326

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 5, 2005

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

January 10, 2011

Status Verified

March 1, 2009

Enrollment Period

3.3 years

First QC Date

December 2, 2005

Last Update Submit

January 7, 2011

Conditions

Optic NeuritisMultiple Sclerosis

Keywords

SimvastatinOptic NeuritisMultiple Sclerosis

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (4)

  • Visual acuity

    6 months

  • visual evokes potentials (VEP)

    6 months

  • cerebral MRI

    6 months

  • Developing MS after 6 months

    6 months

Study Arms (2)

B

ACTIVE COMPARATOR

simvastatin tablets 80 mg daily

Drug: simvastatin

A

PLACEBO COMPARATOR

calcium tablets 80 mg

Drug: placebo

Interventions

simvastatinDRUG

80 mg once daily

B
placeboDRUG

calcium tablets once daily

A

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Glostrup Municipality, Glostrup, DK-2600, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 21921071DERIVED

MeSH Terms

Conditions

Optic NeuritisMultiple Sclerosis

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Optic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesEye DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Jette L Frederiksen, Dr.Med

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 2, 2005

First Posted

December 5, 2005

Study Start

September 1, 2006

Primary Completion

January 1, 2010

Study Completion

May 1, 2011

Last Updated

January 10, 2011

Record last verified: 2009-03

Locations

DK(1)