Relapse ESCalation treatment trial in Optic Neuritis (RESCON)

ISRCTN ISRCTN42343140
DOI https://doi.org/10.1186/ISRCTN42343140
EudraCT/CTIS number 2012-004807-10
Secondary identifying numbers inims-004
Submission date
06/10/2013
Registration date
06/08/2014
Last edited
11/05/2021
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Plasma exchange (PE) is a procedure where the plasma of the blood is replaced by another component called plasma substitute. It has been used as an escalation treatment and after failure of high doses of steroids in the treatment of optic neuritis (inflammation of the optic nerve). However, until now only one study has evaluated PE for the treatment of MS relapses. The current experience in treating optic neuritis that does not respond to steroids with PE is limited. This study will be the first rigorous clinical study in severe optic neuritis that does not respond to steroids, and will provide evidence regarding the effectiveness of PE in optic neuritis.

Who can participate?
Adult patients with optic neuritis that did not respond to steroid treatment and an overall duration of symptoms of less than 4 weeks.

What does the study involve?
Patients will be randomly allocated to two different treatment options: five cycles of plasma exchange or methylprednisolone (a very high dosage of steroid) for five consecutive days.

What are the possible benefits and risks of participating?
Both the treatment options in this study are established therapies so we do not expect to observe unpredictable risks or side effects. If patients in the steroid treatment arm do not respond well, we offer the rescue treatment with plasma exchange 8 weeks after the steroid treatment.

Where is the study run from?
The study will be conducted in five centres in Germany (Hamburg, Heidelberg, Hannover, Berlin and Düsseldorf). The lead centre will be Hamburg.

When is the study starting and how long is it expected to run for?
The study started in October 2013 and will last for about 2 years.

Who is funding the study?
The Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung) (BMBF) (Germany).

Who is the main contact?
Prof Christoph Heesen
heesen@uke.de

Contact information

Prof Christoph Heesen
Scientific

Institute of Neuroimmunology and Clinical MS Research
and Department of Neurology
UKE
Martinistrasse 52
Hamburg
20246
Germany

Email heesen@uke.de

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRelapse ESCalation treatment trial in Optic Neuritis (RESCON): a multi-centre randomised controlled trial to study the effectiveness of plasma exchange (PE) as an escalation treatment strategy in steroid-unresponsive optic neuritis
Study acronymRESCON
Study objectivesPrimary objectives:
1. To gain further evidence for the efficacy of plasma exchange in steroid-unresponsive optic neuritis
2. To study new outcome tools for neuronal regeneration in the ON model via optical coherence tomography (OCT)

Secondary objectives:
1. 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 diffusion tensor imaging (DTI) at baseline, week 16 and 52)
2. To further study biomarkers for ON heterogeneity and neurodegeneration
Ethics approval(s)Ethics Committee of Hamburg, 17/07/2013
Health condition(s) or problem(s) studiedSteroid-unresponsive optic neuritis
InterventionRCT in patients who suffer from severe optic neuritis without satisfying improvement after treatment with steroids.

Treatment arm 1: plasma exchange (PE)
PE will be performed every second day; altogether five exchanges are planned. Each procedure will last about 2-3 hours. After placing a central venous catheter in a jugular or subclavian vein the 1.5-fold plasma volume will be exchanged with the same volume of human albumin 5% or a combination of albumin and hemodilution by continuous-flow centrifugation using a cell separation device.

Treatment arm 2: ultrahigh-dose steroid treatment
Each day 2 g of methylprednisolone will be administered intravenously on five consecutive days.
Intervention typeOther
Primary outcome measureMean retina nerve fiber layer thickness in OCT at week 16 after treatment in comparison between groups
Secondary outcome measures1. Treatment failure at week 2
2. Visual acuity measured at inclusion, week 2, 4, 8, 16, 52 after treatment
3. Visual evoked potential latency measured at inclusion, week 2, 4, 8, 16, 52 after treatment
4. MRI parameters at week 1, 2, 4, 16, 52
Overall study start date10/10/2013
Completion date10/10/2015
Reason abandoned (if study stopped)Participant recruitment issue

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit60 Years
SexBoth
Target number of participants40
Total final enrolment9
Key inclusion criteria1. Optic neuritis with visual acuity < 0.7 at least 7 days after steroid treatment (3-5 x 1 g)
2. Duration of symptoms from onset < 4 weeks
3. Male and female, age: 18-60 years
4. Expanded Disability Status Scale (EDSS): 1.0 – 6.5
5. Clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RR-MS) or secondary progressive multiple sclerosis (SP-MS)
Key exclusion criteria1. 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 two MS-typical lesions
2. Bilateral optic neuritis
3. Positive testing for aquaporin-4 antibodies
4. Current treatment with natalizumab
5. Patients with neuromyelitis optica
6. Pregnancy
7. 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.
Patients with cognitive impairments who are unable to provide written, informed consent prior to any testing under this protocol.
Date of first enrolment10/10/2013
Date of final enrolment10/10/2015

Locations

Countries of recruitment

  • Germany

Study participating centre

Institute of Neuroimmunology and Clinical MS Research
Hamburg
20246
Germany

Sponsor information

University Medical Center Hamburg-Eppendorf (Universitätsklinikum Hamburg-Eppendorf) (Germany)
University/education

c/o Prof. Dr. Dr. Uwe Koch-Gromus
Martinistrasse 52
Hamburg
D-20246
Germany

ROR logo "ROR" https://ror.org/01zgy1s35

Funders

Funder type

Government

The Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung) (BMBF) (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

11/05/2021: The following changes have been made:
1. The study status has been changed to 'Stopped'.
2. The final enrolment number has been added.
10/05/2021: No publications found, verifying study status with principal investigator.