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

Phase 1

• Conditions: 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: 14.1Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.1Level: LLTClassification code 10070425Term: Multiple sclerosis exacerbationSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.1Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-004807-10-DE
• Lead Sponsor: niversity Medical Center Hamburg Eppendorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-26
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

oOptic neuritis with visual acuity < 0.7 after steroid treatment (3-5x1g)
oDuration of symptoms from onset < 4 weeks
oAge: 18-60 years
oEDSS: 1.0 – 6.5
oCIS, 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

oabsence 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
obilateral optic neuritis
ocurrent treatment with natalizumab
opatients with neuromyelitis optica
oPregnancy
oUnwillingness 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.
oPatients with cognitive impairments who are unable to provide written, informed consent prior to any testing under this protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified