NCT00910598

Brief Summary

This is a study in patients with clinically isolated syndrome (CIS) and early relapsing remitting multiple sclerosis (RRMS) to assess the effects of glatiramer acetate (GA) subcutaneously on the condition of the optical nerve in comparison to no medicinal therapy during 12 months and to assess the use of Optical Coherence tomography (OCT), a non-invasive ophthalmological technique, in daily practice as an alternative to magnetic resonance imaging (MRI) scanning for follow-up of these patients.

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
60

participants targeted

Target at P50-P75 for phase_4 multiple-sclerosis

Timeline
Completed

Started Sep 2009

Typical duration for phase_4 multiple-sclerosis

Geographic Reach
1 country

2 active sites

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

May 29, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 1, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

February 10, 2010

Status Verified

February 1, 2010

Enrollment Period

2.8 years

First QC Date

May 29, 2009

Last Update Submit

February 9, 2010

Conditions

Multiple Sclerosis

Keywords

clinically isolated syndromerelapsing remitting multiple sclerosisglatiramer acetateOptical Coherence Tomography

Outcome Measures

Primary Outcomes (1)

  • Feasibility of OCT measurement in patient with CIS with or without optic neuritis or with early RRMS in the Dutch clinical setting

    1 year

Secondary Outcomes (2)

  • Mean change in RNFL in both eyes determined by OCT at baseline, month 3, month 6, month 9, month 12

    1 year

  • Other ophthalmological parameters

    1 year

Study Arms (2)

glatiramer acetate

EXPERIMENTAL

glatiramer acetate 20 mg s.c. daily for 1 year

Drug: glatiramer acetate

no treatment

NO INTERVENTION

No disease modifying treatment allowed

Interventions

glatiramer acetateDRUG

20 mg daily s.c. for 1 year

Also known as: Copaxone
glatiramer acetate

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18 - 55 years
  • Early relapsing remitting MS, defined as a disease course less than 3 years
  • clinically isolated syndrome , defined as optic neuritis (ON) or other than ON
  • Currently treated with glatiramer (GA) or currently not treated for MS
  • Expanded disability status scale (EDSS) score 0-5
  • Able and willing to provide written informed consent prior to enrolment
  • Willing and able to comply with the protocol requirements for the duration of the study

You may not qualify if:

  • Clinical definite multiple sclerosis with a disease course more than 3 years
  • Primary progressive multiple sclerosis
  • Secondary progressive multiple sclerosis
  • Current use of any approved or investigational disease modifying agents for the treatment of MS other than GA.
  • Neuromyelitis Optica (Devic's disease)
  • Any condition that may interfere with the quality of the OCT scan: clouding of the media, i.e. cataract, pupil which are hard to dilate.
  • Contra-indications for Copaxone ® as defined in the Summary of Product Characteristics (SPC) text
  • Hypersensitivity to GA or mannitol
  • Subject's inability to complete the study or if the subject is considered by the investigator to be for any reason, an unsuitable candidate for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Amphia Ziekenhuis

Breda, 4818 CK, Netherlands

RECRUITING

Maasland Ziekenhuis

Sittard, Netherlands

RECRUITING

Related Links

MeSH Terms

Conditions

Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting

Interventions

Glatiramer Acetate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • E.C.A.M. Sanders, MD

    Amphia ziekenhuis

    STUDY CHAIR

Central Study Contacts

E.C.A.M. Sanders, MD

CONTACT

+31 76 5258246rsc@rsconsultancy.nl

Raymond J. Schmidt, MD

CONTACT

+31 575 441001rsc@rsconsultancy.nl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 29, 2009

First Posted

June 1, 2009

Study Start

September 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

February 10, 2010

Record last verified: 2010-02

Locations

NL(2)