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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671682
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Albert Christian Ludolph, Prof., University of Ulm

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Clinically Isolated Syndrome Procedure: Immunoadsorption Procedure: Plasmapheresis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunoadsorption vs. Plasmapheresis in the Escalation Therapy of Relapse in Multiple Sclerosis and Clinically Isolated Syndrome
Actual Study Start Date : February 26, 2016
Actual Primary Completion Date : January 3, 2019
Actual Study Completion Date : January 25, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Immunoadsorption
Immunoadsorption on 5 consecutive days with protein A columns and 2,5-fold patient's plasma volume
Procedure: Immunoadsorption
Active Comparator: Plasmapheresis
Plasmapheresis on 5 consecutive days with 2l plasma exchange
Procedure: Plasmapheresis



Primary Outcome Measures :
  1. Multiple Sclerosis Functional Composite (MSFC) [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671682


Locations
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Germany
Department of Neurology, University of Ulm
Ulm, Baden-Württemberg, Germany, 89081
Sponsors and Collaborators
Albert Christian Ludolph, Prof.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Albert Christian Ludolph, Prof., Prof. Dr., University of Ulm
ClinicalTrials.gov Identifier: NCT02671682    
Other Study ID Numbers: IAPEMS
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Albert Christian Ludolph, Prof., University of Ulm:
Immunoadsorption
Plasmapheresis
Additional relevant MeSH terms:
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Multiple Sclerosis
Syndrome
Sclerosis
Disease
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases