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

GBS Clinical Trial

— IPET-GBS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04871035
• Other study ID #: IPET-GBS 1.2
• Status: Recruiting
• Start date: April 28, 2021
• Est. completion date: May 4, 2025

Study information

• Verified date: May 2024
• Source: University of Ulm
• Contact: Johannes Dorst, Prof
• Phone: +49 731 177 5285
• Email: johannes.dorst[@]uni-ulm.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 4, 2025
• Est. primary completion date: May 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• GBS
• Guillain-Barre Syndrome

Intervention

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
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.

Locations

Country	Name	City	State
Germany	Department of Neurology, University of Ulm	Ulm	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulm	DiaMed GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score	Combined score consisting of Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Oxford muscle strength score, and vibration score, equally weighted	2 weeks
Primary	Inflammatory Neuropathy Cause and Treatment (INCAT) disability score	Standard clinical score for inflammatory neuropathies.	2 weeks
Primary	Oxford Muscle Strength Score (Medical Research Council, MRC)	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).	2 weeks
Primary	Vibration Score	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).	2 weeks
Secondary	Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score	Combined score consisting of Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Oxford muscle strength score, and vibration score, equally weighted	1, 3, and 5 weeks
Secondary	Inflammatory Neuropathy Cause and Treatment (INCAT) disability score	Standard clinical score for inflammatory neuropathies.	1, 3, and 5 weeks
Secondary	Oxford Muscle Strength Score (Medical Research Council, MRC)	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).	1, 3, and 5 weeks
Secondary	Vibration Score	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).	1, 3, and 5 weeks
Secondary	Hughes Score	Standard clinical score to quantify disability in Guillain-Barré syndrome	1, 2, 3, and 5 weeks
Secondary	Pain	Pain quantified on a visual analog scale between 0 (no pain) and 10 (maximum pain).	1, 2, 3, and 5 weeks
Secondary	N20	N20 latency of nervus medianus (both sides) as measured by somatosensory evoked potentials (SEPs)	2 and 5 weeks
Secondary	P40	P40 latency of nervus tibialis (both sides) as measured by somatosensory evoked potentials	2 and 5 weeks
Secondary	Nerve Conduction Velocity	Nerve conduction velocity of clinically affected nerves as measured by electroneurography (ENG)	2 and 5 weeks
Secondary	Euro Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L)	Quality of Life Scale	1, 2, 3, and 5 weeks
Secondary	Immunoglobulin A in serum	Immunoglobulin A serum concentration	1, 2, 3, and 5 weeks
Secondary	Immunoglobulin A in cerebrospinal fluid (CSF)	Immunoglobulin A concentration in cerebrospinal fluid	2 weeks
Secondary	Immunoglobulin G in serum	Immunoglobulin G serum concentration	1, 2, 3, and 5 weeks
Secondary	Immunoglobulin G in cerebrospinal fluid (CSF)	Immunoglobulin G concentration in cerebrospinal fluid	2 weeks
Secondary	Immunoglobulin M in serum	Immunoglobulin M serum concentration	1, 2, 3, and 5 weeks
Secondary	Immunoglobulin M in cerebrospinal fluid (CSF)	Immunoglobulin M concentration in cerebrospinal fluid	2 weeks
Secondary	Interleukin-1	Interleukin-1 serum concentration	1, 2, 3, and 5 weeks
Secondary	Interleukin-6	Interleukin-6 serum concentration	1, 2, 3, and 5 weeks
Secondary	Anti-GM1 antibodies	Anti-GM1 antibody serum levels	1, 2, 3, and 5 weeks
Secondary	Anti-GQ1b	Anti-GQQ1b antibody serum levels	1, 2, 3, and 5 weeks
Secondary	Neurofilament light chain (NfL) serum	Neurofilament light chain (NfL) serum levels	1, 2, 3, and 5 weeks
Secondary	Neurofilament light chain (NfL) in cerebrospinal fluid (CSF)	Neurofilament light chain (NfL) levels in cerebrospinal fluid (CSF)	2 weeks
Secondary	Safety and Tolerability	Kind and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)	1, 2, 3, and 5 weeks
Secondary	Therapeutic Response	Share of patients with at least 20% improvement in CIDP score	1, 2, 3, and 5 weeks