Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Christoph Heesen
ORCID ID
Contact details
Institute of Neuroimmunology and Clinical MS Research
and Department of Neurology
UKE
Martinistrasse 52
Hamburg
20246
Germany
heesen@uke.de
Additional identifiers
EudraCT number
2012-004807-10
ClinicalTrials.gov number
Protocol/serial number
inims-004
Study information
Scientific title
Relapse 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
Acronym
RESCON
Study hypothesis
Primary 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
Ethics Committee of Hamburg, 17/07/2013
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Steroid-unresponsive optic neuritis
Intervention
RCT 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 type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Mean retina nerve fiber layer thickness in OCT at week 16 after treatment in comparison between groups
Secondary outcome measures
1. 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 trial start date
10/10/2013
Overall trial end date
10/10/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. 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.
Recruitment start date
10/10/2013
Recruitment end date
10/10/2015
Locations
Countries of recruitment
Germany
Trial participating centre
Institute of Neuroimmunology and Clinical MS Research
Hamburg
20246
Germany
Funders
Funder type
Government
Funder name
The Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung) (BMBF) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list