A Phase 4 interventional study of glatiramer acetate in Multiple Sclerosis, sponsored by Amphia Hospital. Status unknown at 2 sites in Netherlands. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2010-02-10.
Sponsored by Amphia Hospital · Phase 4, Interventional, and Treatment
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.
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Amphia Hospital is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
glatiramer acetate 20 mg s.c. daily for 1 year
Drug: glatiramer acetate
No disease modifying treatment allowed
20 mg daily s.c. for 1 year
Also known as: Copaxone
Feasibility of OCT measurement in patient with CIS with or without optic neuritis or with early RRMS in the Dutch clinical setting
Time frame: 1 year
Mean change in RNFL in both eyes determined by OCT at baseline, month 3, month 6, month 9, month 12
Time frame: 1 year
Other ophthalmological parameters
Time frame: 1 year
This study is status unknown, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.
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Amphia Hospital