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Immunoadsorption Versus Plasma Exchange for Treatment of Guillain-Barré Syndrome (GBS) (IPET-GBS)

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ClinicalTrials.gov Identifier: NCT04871035
Recruitment Status : Recruiting
First Posted : May 4, 2021
Last Update Posted : September 29, 2021
Sponsor:
Collaborator:
DiaMed GmbH
Information provided by (Responsible Party):
Albert Christian Ludolph, Prof., University of Ulm

Study Description
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Brief Summary:
This is an observations study evaluating safety and efficacy of immunoadsorption compared to plasma exchange in Guillain-Barré Syndrome.

Condition or disease Intervention/treatment
GBS Device: Immunoadsorption Device: Plasma Exchange

Study Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immunoadsorption Versus Plasma Exchange for Treatment of Guillain-Barré Syndrome (GBS)
Actual Study Start Date : April 28, 2021
Estimated Primary Completion Date : May 4, 2023
Estimated Study Completion Date : May 4, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Immunoadsorption Device: Immunoadsorption
1 cycle, consisting of 5 sessions on 5 consecutive days with processing of the 0.7-fold individual plasma volume (maximum 2.5 l) each days with tryptophan adsorbers.
Plasma Exchange Device: Plasma Exchange
1 cycle, consisting of 5 sessions on 5 consecutive days with exchange of 0.7-fold plasma volume (maximum 2.5 l) each day with albumin solution as volume replacement solution.


Outcome Measures
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Primary Outcome Measures :
  1. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score [ Time Frame: 2 weeks ]
    Combined score consisting of Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Oxford muscle strength score, and vibration score, equally weighted

  2. Inflammatory Neuropathy Cause and Treatment (INCAT) disability score [ Time Frame: 2 weeks ]
    Standard clinical score for inflammatory neuropathies.

  3. Oxford Muscle Strength Score (Medical Research Council, MRC) [ Time Frame: 2 weeks ]
    Standard clinical score for evaluating muscle strength / paresis. Muscle strength will be measured on a scale between 0 (no movement) and 5 (full strength) on 8 pre-defined muscles (one proximal and one distal muscle at each extremity).

  4. Vibration Score [ Time Frame: 2 weeks ]
    Standard clinical score for evaluation of vibration sensitivity on a scale between 0 and 8, using a 256 tuning fork at 4 predefined spots (processus styloideus radii and malleolus lateralis on both sides).


Secondary Outcome Measures :
  1. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score [ Time Frame: 1, 3, and 5 weeks ]
    Combined score consisting of Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Oxford muscle strength score, and vibration score, equally weighted

  2. Inflammatory Neuropathy Cause and Treatment (INCAT) disability score [ Time Frame: 1, 3, and 5 weeks ]
    Standard clinical score for inflammatory neuropathies.

  3. Oxford Muscle Strength Score (Medical Research Council, MRC) [ Time Frame: 1, 3, and 5 weeks ]
    Standard clinical score for evaluating muscle strength / paresis. Muscle strength will be measured on a scale between 0 (no movement) and 5 (full strength) on 8 pre-defined muscles (one proximal and one distal muscle at each extremity).

  4. Vibration Score [ Time Frame: 1, 3, and 5 weeks ]
    Standard clinical score for evaluation of vibration sensitivity on a scale between 0 and 8, using a 256 tuning fork at 4 predefined spots (processus styloideus radii and malleolus lateralis on both sides).

  5. Hughes Score [ Time Frame: 1, 2, 3, and 5 weeks ]
    Standard clinical score to quantify disability in Guillain-Barré syndrome

  6. Pain [ Time Frame: 1, 2, 3, and 5 weeks ]
    Pain quantified on a visual analog scale between 0 (no pain) and 10 (maximum pain).

  7. N20 [ Time Frame: 2 and 5 weeks ]
    N20 latency of nervus medianus (both sides) as measured by somatosensory evoked potentials (SEPs)

  8. P40 [ Time Frame: 2 and 5 weeks ]
    P40 latency of nervus tibialis (both sides) as measured by somatosensory evoked potentials

  9. Nerve Conduction Velocity [ Time Frame: 2 and 5 weeks ]
    Nerve conduction velocity of clinically affected nerves as measured by electroneurography (ENG)

  10. Euro Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) [ Time Frame: 1, 2, 3, and 5 weeks ]
    Quality of Life Scale

  11. Immunoglobulin A in serum [ Time Frame: 1, 2, 3, and 5 weeks ]
    Immunoglobulin A serum concentration

  12. Immunoglobulin A in cerebrospinal fluid (CSF) [ Time Frame: 2 weeks ]
    Immunoglobulin A concentration in cerebrospinal fluid

  13. Immunoglobulin G in serum [ Time Frame: 1, 2, 3, and 5 weeks ]
    Immunoglobulin G serum concentration

  14. Immunoglobulin G in cerebrospinal fluid (CSF) [ Time Frame: 2 weeks ]
    Immunoglobulin G concentration in cerebrospinal fluid

  15. Immunoglobulin M in serum [ Time Frame: 1, 2, 3, and 5 weeks ]
    Immunoglobulin M serum concentration

  16. Immunoglobulin M in cerebrospinal fluid (CSF) [ Time Frame: 2 weeks ]
    Immunoglobulin M concentration in cerebrospinal fluid

  17. Interleukin-1 [ Time Frame: 1, 2, 3, and 5 weeks ]
    Interleukin-1 serum concentration

  18. Interleukin-6 [ Time Frame: 1, 2, 3, and 5 weeks ]
    Interleukin-6 serum concentration

  19. Anti-GM1 antibodies [ Time Frame: 1, 2, 3, and 5 weeks ]
    Anti-GM1 antibody serum levels

  20. Anti-GQ1b [ Time Frame: 1, 2, 3, and 5 weeks ]
    Anti-GQQ1b antibody serum levels

  21. Neurofilament light chain (NfL) serum [ Time Frame: 1, 2, 3, and 5 weeks ]
    Neurofilament light chain (NfL) serum levels

  22. Neurofilament light chain (NfL) in cerebrospinal fluid (CSF) [ Time Frame: 2 weeks ]
    Neurofilament light chain (NfL) levels in cerebrospinal fluid (CSF)

  23. Safety and Tolerability [ Time Frame: 1, 2, 3, and 5 weeks ]
    Kind and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  24. Therapeutic Response [ Time Frame: 1, 2, 3, and 5 weeks ]
    Share of patients with at least 20% improvement in CIDP score


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population consists of patients diagnosed with Guillain-Barré syndrome (GBS) who are treated with either plasma exchange or immunoadsorption in the Department of Neurology, University of Ulm.
Criteria

Inclusion Criteria:

  • Diagnosis of Guillain-Barré Syndrome according to the diagnostic criteria proposed by Doorn et al. (Clinical features, pathogenesis, and treatment of Guillain-Barré syndrome, Lancet neurology 2008)
  • age 18 years or above

Exclusion Criteria:

  • Clinical or laboratory (C-reactive protein 20 mg/l or above, or evidence of nitrite-positive urinary tract infection) evidence of manifest systemic infection
  • Intake of angiotensin converting enzyme inhibitor within1 weeks before first treatment
  • Other contraindications against immunoadsorption or plasma exchange
Contacts and Locations
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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): NCT04871035


Contacts
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Contact: Johannes Dorst, Prof +49 731 177 5285 johannes.dorst@uni-ulm.de

Locations
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Germany
Department of Neurology, University of Ulm Recruiting
Ulm, Baden-Württemberg, Germany, 89081
Contact: Albert C Ludolph, MD, Prof.    +49-731-177- ext 1200    albert.ludolph@rku.de   
Principal Investigator: Albert C Ludolph, MD, Prof.         
Sponsors and Collaborators
University of Ulm
DiaMed GmbH
Investigators
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Principal Investigator: Johannes Dorst, Prof University of Ulm
More Information
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Responsible Party: Albert Christian Ludolph, Prof., Prof. Dr., University of Ulm
ClinicalTrials.gov Identifier: NCT04871035    
Other Study ID Numbers: IPET-GBS 1.2
First Posted: May 4, 2021    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, and figures), as well as the study protocol will be available. Data will be available beginning 3 months and ending 5 years following article publication. Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal. Proposals should be directed to johannes.dorst@uni-ulm.de; to gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at https://www.uniklinik-ulm.de/neurologie.html.
Supporting Materials: Study Protocol
Time Frame: 3 months after publication until 5 years after publication
Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal.
URL: https://www.uniklinik-ulm.de/neurologie.html

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Guillain-Barre Syndrome
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
 Peripheral Nervous System Diseases
Neuromuscular Diseases
Polyneuropathies
Autoimmune Diseases
Immune System Diseases