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Clinical Trials/EUCTR2012-004807-10-DE
EUCTR2012-004807-10-DEActive, not recruitingPhase 1

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

niversity Medical Center Hamburg Eppendorf0 sites40 target enrollmentStarted: October 26, 2012Last updated:
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Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
40
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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
  • •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

Investigators

Sponsor
niversity Medical Center Hamburg Eppendorf

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