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

What Was Tested

In this phase 4 trial, researchers set out to test Glatiramer Acetate for multiple sclerosis.

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.

It had two arms (groups): glatiramer acetate (experimental) and no treatment (no intervention).

No disease modifying treatment allowed.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

Enrollment: 60 planned participants were the target.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: clinical definite multiple sclerosis with a disease course more than 3 years; primary progressive multiple sclerosis; secondary progressive multiple sclerosis.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the multiple sclerosis participants stayed in one arm throughout.

Everyone knew when Glatiramer Acetate was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2009-09 with completion listed for 2012-06.

It ran at 2 sites in Netherlands (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 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).

It also tracked 2 secondary outcomes, for example Mean change in RNFL in both eyes determined by OCT at baseline, month 3, month 6, month 9, month 12 and Other ophthalmological parameters.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Glatiramer Acetate in 60 people with multiple sclerosis.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glatiramer Acetate compound page, Multiple sclerosis research.