CompletedNot a drug-phase studyEarly (CIS/RIS)NCT02671682

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Immunoadsorption

Compared with

  • Plasmapheresis

What it measured

Main measures

  • Multiple Sclerosis Functional Composite (MSFC)

    4 weeks

    Disability progression

Other measures (11)

  • Expanded Disability Status Scale (EDSS)

    2 and 4 weeks

    Disability progression
  • EuroQol (EQ5D-5L)

    2 and 4 weeks

    Quality of life (reported by participants)
  • Response Rate

    4 weeks

    Disability progression
  • Vision

    4 weeks

    Disability progressionVision
  • Visually Evoked Potentials (VEP; P100 latency)

    4 weeks

    Myelin repair
  • Somatosensory Evoked Potentials (SEP; Medianus and Tibialis; N20-, P40-latency)

    4 weeks

    Myelin repair
  • Thickness of Retinal Nerve Fiber Layer (RNFL) in Optical Coherence Tomography (OCT)

    4 weeks

    Retina scans (OCT)
  • Verbaler Lern- und Merkfähigkeitstest (VLMT) score

    4 weeks

  • MSFC

    2 weeks

    Disability progression
  • Thickness of Ganglion Cell Layer (GCL) in OCT

    4 weeks

    Retina scans (OCT)

Who could take part

Early (CIS/RIS) · 12 to 80

Inclusion Criteria: * relapse of Multiple Sclerosis or Clinically Isolated Syndrome (without complete remission after high dose steroid therapy) * informed consent * age ≥ 12 years old Exclusion Criteria: * clinical or laboratory signs of infection * intake of Angiotensin Converting Enzyme Inhibitor within 1 week prior to first treatment

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

This observational study investigates the efficacy and safety of immunoadsorption versus plasmapheresis in 60 patients with relapse in Multiple Sclerosis and Clinically isolated syndrome who do not fully recover after a high doses of intravenous corticosteroids.

Papers

Loading reviews and guidelines…

History

    1. Started

      Feb 2016

    2. Main results due

      Jan 2019

    3. Finished

      Jan 2019

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