Relapse Escalation treatment trial in Optic Neuritis (RESCON): Multi-centre RCT to study the efficacy of plasma exchange (PE) as an escalation treatment strategy in steroid-unresponsive Optic Neuritis

• Register: EUCTR
• Last refreshed on: 5 April 2021
• Main ID: EUCTR2012-004807-10-DE
• Date of registration: 26/10/2012
• Prospective Registration: Yes
• Primary sponsor: University Medical Center Hamburg Eppendorf
• Public title: Relapse Escalation treatment trial in Optic Neuritis (RESCON): Multi-centre RCT to study the efficacy of plasma exchange (PE) as an escalation treatment strategy in steroid-unresponsive Optic Neuritis
• Scientific title: Relapse Escalation treatment trial in Optic Neuritis (RESCON): Multi-centre RCT to study the efficacy of plasma exchange (PE) as an escalation treatment strategy in steroid-unresponsive Optic Neuritis
• Date of first enrolment: 17/07/2013
• Target sample size: 40
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004807-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: yes; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Germany

Contacts

• Name: inims and MS dayclinic
• Affiliation: University Medical Center Hamburg Eppendorf

• Name: inims and MS dayclinic
• Affiliation: University Medical Center Hamburg Eppendorf

Key inclusion & exclusion criteria

Inclusion criteria:
o Optic neuritis with visual acuity < 0.7 after steroid treatment (3-5x1g)
o Duration of symptoms from onset < 4 weeks
o Age: 18-60 years
o EDSS: 1.0 – 6.5
o CIS, RR-MS or SP-MS

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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

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 sclerosis exacerbation System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

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 descriptive name: METHYLPREDNISOLONE
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-

Primary Outcome(s)

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

Timepoint(s) of evaluation of this end point: Week 16

Primary end point(s): Difference of Mean RNFL thickness in both groups at week 16

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: week 1, 2, 4, 16, 52

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

Secondary ID(s)

inims-004

Source(s) of Monetary Support

University Medical Center Hamburg Eppendorf

Ethics review

Status: Approved
Approval date: 17/07/2013
Contact: