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NCT Number: NCT04871035

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

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

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Key information

Conditions

GBS

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology, University of Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

Location status: Recruiting

Location contact

Albert C Ludolph, MD, Prof.

CONTACT

[email protected]

+49-731-177- ext. 1200

Albert C Ludolph, MD, Prof.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Immunoadsorption

Device

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

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.

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Johannes Dorst, Prof

CONTACT

[email protected]

+49 731 177 5285

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Collaborators

  • DiaMed GmbH

Registry information

Acronym: IPET-GBS

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
May 4, 2021
Registry last updated
May 1, 2026

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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