Simvastatin Treatment of Patients With Acute Optic Neuritis | NCT00261326

Studies
Simvastatin Treatment of Patients With Acute Optic Neuritis

NCT00261326

Sponsor

Glostrup University Hospital, Copenhagen

Status

Unknown status

Last Update Posted

Jan 10, 2011Estimated

Enrollment

64Estimated

Phase

Phase 3

Conditions

Optic Neuritis
Multiple Sclerosis

Interventions

simvastatin
placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
KA 04068gs	Other Identifier	Regional scientific ethics Committe

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Jan 2010Estimated

Completion Date

May 2011Estimated

First Submitted Date

Dec 2, 2005

First Submission Date that Met QC Criteria

Dec 2, 2005

First Posted Date

Dec 5, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2011

Last Update Posted Date

Jan 10, 2011Estimated

Name	Class
Alpharma ApS	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
B	Active Comparator	simvastatin tablets 80 mg daily	Drug: simvastatin
A	Placebo Comparator	calcium tablets 80 mg	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
simvastatin	Drug	80 mg once daily	B
placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The contrast sensibility of the eye after 3 months of the treatment		6 months

Secondary Outcomes

Measure	Description	Time Frame
Visual acuity		6 months
visual evokes potentials (VEP)		6 months
cerebral MRI

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

59 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jette L Frederiksen, Dr.Med		Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The clinic of the research for optic neuritis and MS, The Dpt. of Neurology at Glostrup Hospital		Glostrup Municipality	Glostrup	DK-2600	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21921071	Derived	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.

Type	Date	Date Unknown
Release	Oct 22, 2013
Unrelease		Yes
Release	Aug 11, 2014
Reset	Aug 25, 2014

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 22, 2013		Yes
Aug 11, 2014

ID	Term
D009901	Optic Nerve Diseases
D003389	Cranial Nerve Diseases
D009422	Nervous System Diseases
D005128	Eye Diseases

ID	Term
D008148	Lovastatin
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic