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Completed

NCT Number: NCT02671682

Immunoadsorption vs. Plasmapheresis in the Escalation Therapy of Relapse in Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Clinically Isolated Syndrome Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

12 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, University of Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immunoadsorption

Procedure

Plasmapheresis

Procedure

Primary outcomes

  1. Multiple Sclerosis Functional Composite (MSFC)

    Time frame: 4 weeks

Secondary outcomes

  1. Expanded Disability Status Scale (EDSS)

    Time frame: 2 and 4 weeks

  2. EuroQol (EQ5D-5L)

    Time frame: 2 and 4 weeks

  3. Response Rate

    Time frame: 4 weeks

    defined as share of patients who show an improvement of least 10% in MSFC (see Outcome 1) compared to baseline value

  4. Vision

    Time frame: 4 weeks

    defined as percentage of normal vision as measured by visual test according to EDSS standardized testing (see outcome 2)

  5. Visually Evoked Potentials (VEP; P100 latency)

    Time frame: 4 weeks

  6. Somatosensory Evoked Potentials (SEP; Medianus and Tibialis; N20-, P40-latency)

    Time frame: 4 weeks

  7. Thickness of Retinal Nerve Fiber Layer (RNFL) in Optical Coherence Tomography (OCT)

    Time frame: 4 weeks

  8. Verbaler Lern- und Merkfähigkeitstest (VLMT) score

    Time frame: 4 weeks

  9. MSFC

    Time frame: 2 weeks

  10. Thickness of Ganglion Cell Layer (GCL) in OCT

    Time frame: 4 weeks

  11. Symbol Digit Modalities Test (SDMT) score

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Albert Christian Ludolph, Prof.

Other

Registry information

Official study title

Immunoadsorption vs. Plasmapheresis in the Escalation Therapy of Relapse in Multiple Sclerosis and Clinically Isolated Syndrome

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 2, 2016
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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