Optical Coherence Tomography: Glatiramer in Clinically Isolated Syndrome or Early Relapsing Remitting Multiple Sclerosis (MS)

NCT ID: NCT00910598

Last Updated: 2010-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-06-30

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.

Detailed Description

Multiple sclerosis (MS) is a progressive and demyelinating disease of the central nervous system characterized by inflammation and neurodegeneration. It is characterized by an ongoing process of demyelination and axonal loss, even at the beginning of the disease course, which will result in brain atrophy. A first manifestation of clinical definite MS, is called a clinically isolated syndrome (CIS). Brain atrophy occurs even in patients with a CIS. Optic neuritis (ON) is a common feature of a CIS. The axons in the retina represent the most proximal part of the optic nerve which is devoid of myelin. Because the retina is part of the central nervous system (CNS), measurement of the Retinal Nerve Fiber Layer (RFLN) by Optical Coherence Tomography (OCT) offers the opportunity to visualize the unmyelinated axons of the CNS directly. OCT is a non-invasive method to measure the thickness of the optical layer. The thickness of the RNFL is reduced in MS patients with or without ON history.

Glatiramer acetate (GA), an immunomodulatory drug for RRMS and CIS, reduces brain atrophy and stimulates the production of brain-derived neurotrophic factor, which in turn could stimulate neuroregeneration.

In this pilot study we would like to assess the feasibility of OCT measurement in patient with CIS other than ON in the Dutch clinical setting and to assess the effect of GA on the RNFL and visual function in patients with CIS or in early relapsing remitting MS patients.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

glatiramer acetate

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

Group Type: EXPERIMENTAL

glatiramer acetate

Intervention Type: DRUG

20 mg daily s.c. for 1 year

no treatment

No disease modifying treatment allowed

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

glatiramer acetate

20 mg daily s.c. for 1 year

Intervention Type: DRUG

Other Intervention Names

Copaxone

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

TEVA Pharmachemie

UNKNOWN

Sponsor Role: collaborator

Amphia Hospital

OTHER

Sponsor Role: lead

Responsible Party

Amphia Ziekenhuis

Principal Investigators

E.C.A.M. Sanders, MD

Role: STUDY_CHAIR

Amphia ziekenhuis

Locations

Amphia Ziekenhuis

Breda, , Netherlands

Site Status: RECRUITING

Maasland Ziekenhuis

Sittard, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

E.C.A.M. Sanders, MD

Role: CONTACT

rsc@rsconsultancy.nl

+31 76 5258246

Raymond J. Schmidt, MD

Role: CONTACT

rsc@rsconsultancy.nl

+31 575 441001

Facility Contacts

E.C.A.M. Sanders, MD

Role: primary

+31 76 5258246

R.M.M. Hupperts, MD PhD

Role: primary

+31 88 4597811

Related Links

http://www.amphia.nl

Amphia Hospital Breda Netherlands

Other Identifiers

OCT

Identifier Type: -

Identifier Source: org_study_id