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
- Conditions
- clinical isolated syndromeMedDRA version: 9.1Level: LLTClassification code 10028248Term: Multiple sclerosis-like syndrome
- Registration Number
- EUCTR2009-013129-41-NL
- Lead Sponsor
- Amphia Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the feasibility of optical coherence tomography (OCT) measurement in patient with CIS other than optic neuritis (ON) or in patients with early MS in the Dutch clinical setting by qualitative evaluation;Secondary Objective: To assess the efficacy of GA on the Retinal Nerve Fiber Layer (RNFL) and visual function in patients with CIS as determined by the mean change in RNFL;Primary end point(s): •Feasibility of OCT measurement in patient with CIS other than ON or with early RRMS in the Dutch clinical setting.<br>•Mean change in RNFL in both eyes determined by OCT at baseline, month 3, month 6, month 9, month 12.<br>
- Secondary Outcome Measures
Name Time Method