MS patients who suffer from severe Optic Neuritis without satisfying improvement after treatment with steroids (3-5 days with 1 g daily at least 7 days prior to randomization) and with persisting visual acuity < 0.7, duration of symptoms should be = 4 weeks MedDRA version: 14.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1 Level: LLT Classification code 10070425 Term: Multiple
Conditions
Interventions
Trade Name: Urbason® solubile forte 1000 mg
Product Name: Methylprednisolone
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Methylprednisolone
CAS Number: 83-43-2
Other des
Sponsors
University Medical Center Hamburg Eppendorf
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: o Optic neuritis with visual acuity =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: o absence of evidence of inflammatory activity which is defined as a lack of inflammatory CSF signs (pleocytosis and/or OCBs) or a present MRI without at least 2 MS-typical lesions o bilateral optic neuritis o current treatment with natalizumab o patients with neuromyelitis optica o Pregnancy o Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the patient returning for follow-up visits on schedule. o Patients with cognitive impairments who are unable to provide written, informed consent prior to any testing under this protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - to study MRI parameters in patients with steroid-unresponsive optic neuritis treated with plasma exchange (contrast-enhancement, T2-signal, edema and atrophy will be assessed as well as DTI at baseline, week 16 and 52) - to further study biomarkers for ON heterogeneity and neurodegeneration ;Main Objective: - to gain further evidence for the efficacy of plasma exchange in steroid-unresponsive optic neuritis - to study new outcome tools for neuronal regeneration in the ON model via OCT ;Primary end point(s): Difference of Mean RNFL thickness in both groups at week 16;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Treatment failure at week 2, Opthalmological parameters (Visual acuity, visual evoked potentials, perimetry) at week 1, 2, 4, 16, 52, MRI: Gadolineum-enhancing lesions, T2 signal in the optic nerve, optic diameter postbulbar and prechiasmatic, Diffusion-tesnor imaging of optic nerve ;Timepoint(s) of evaluation of this end point: week 1, 2, 4, 16, 52 | — |
Countries
Germany
Contacts
Public Contactinims and MS dayclinic
University Medical Center Hamburg Eppendorf
Outcome results
None listed