A multicenter open label randomized pilot study, to compare retinal nerve fiber layer thickness measured by Optical Coherence Tomography after treatment with daily 20 mg glatiramer acetate subcutaneously or after no treatment, in patients with a clinical isolated syndrome, other than optic neuritis or early relapsing remitting multiple sclerosis patients - OCT

Amphia Ziekenhuis0 个研究点开始时间: 2009年6月3日最近更新: 2012年3月19日

研究概览

暂无简介。

•Age: 18 – 45 years
•Early RRMS, defined as a disease course less than 3 years
•CIS other than ON
•Expanded disability status scale (EDSS) score 0-4
•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Clinical definite multiple sclerosis (CDMS) with a disease course more than 3 years
•Acute ON or a history of ON
•Primary progressive multiple sclerosis
•Secondary progressive multiple sclerosis
•Current use of any approved or investigational disease modifying agents for the treatment of MS.
•Neuromyelitis Optica (Devic’s disease)
•Any condition that may interfere with the quality of the OCT scan: clouding of the media, e.i. 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.

发起方

Amphia Ziekenhuis