IVIG Versus Plasmapheresis in the Treatment of Guillian Barrie Syndrome Patients

NCT05104762 | Completed Phase 2 DMC

• 1 other identifier: Guillian Barrie syndrome
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators address the question: whether treatment with IVIG is superior to treatment using plasmapheresis for functional recovery of patients with GBS? Recovery was quantified using: The changes in the A-Clinical grading scale MRC ( medial research council sum score ) and B-overall neuropathy limitations scale as the primary outcome and the changes in Neurophysiological study 3 months after treatment as a secondary outcome. This information will be used to evaluate which treatment is more beneficial to GBS patients.

Conditions

Guillain-Barre Syndrome

Keywords

IVIG / plasmapheresis and Guillain-Barre Syndrome

Outcome Measures

Primary Outcomes (3)

• Clinical grading scale MRC ( medial research council sum score )

  Clinical grading scale MRC ( medial research council sum score ) from zero ( no power ) up to 60 full power (points): sum score of muscle power in both upper limbs and lower limbs in points .

  the points change from baseline scale and after 3 months follow up

• Overall neuropathy limitations scale (ONLS) .

  it is modified disability sum score: sum of arm grade and leg grade limitation score; arm grade from zero point ( less limitation ) to 5 points ( most limitation ) and leg grade from zero point ( less limitation) to 7 points (more limitation)

  the changes in points from baseline assessment score to 3 months follow up assessment score.

• ERASMUS GBS respiratory insufficiency score EGRIS

  Predict the probability of respiratory insufficiency within the first week of admission, in individual patients with Guillain-Barre. syndrome from zero to 7 points score : 0 point ( no affection ) , 7 point ( severe affection )

  the change in points from baseline assessment score to 3 months follow up assessment score.

Secondary Outcomes (1)

• Neurophysiological study: Distal latency in mill second, Nerve conduction velocities in Meter/second, and F-wave latency mill second

  the change in points from baseline assessment score to 3 months follow up assessment score.

Study Arms (2)

Arm 1 plasmapheresis

ACTIVE COMPARATOR

Arm 1 (plasmapheresis): This study will be conducted at Assiut University at Neurology and psychiatry department as Group 1 of patients presented with Guillian Barrie syndrome (54 patients) will be subjected to plasmapheresis after assessment of clinical state and scales including MRC, Erasmus Guillain-Barre respiratory insufficiency score and Overall neuropathy limitation scale and Neurophysiological studies. Each patient was evaluated at baseline and at Follow up assessment points (one month and 3 months, one year follow up)

Device: plasmapheresis device

Arm 2: Intravenous injection of immunoglobulin

ACTIVE COMPARATOR

This study will be conducted at Assiut University at Neurology and psychiatry department as Group 2 of patients presented with Guillian Barrie syndrome (27 patients) will be subjected to intravenous injection of immunoglobulin after assessment of clinical state and scales including MRC, Erasmus Guillain-Barre respiratory insufficiency score, and Overall neuropathy limitation scale and Neurophysiological studies. Each patient was evaluated at baseline and at Follow up assessment points (one month and 3 months, one year follow up).

Drug: Intravenous immunoglobulin

Interventions

plasmapheresis device DEVICE

Group 1: 54 patients of Guillian Barrie syndrome undergo plasma exchange (5 sessions)

Also known as: plasma exchange device

Arm 1 plasmapheresis

Intravenous immunoglobulin DRUG

group 2: 27 patients undergo intravenous injection of immunoglobulin for 5 consecutive days of IVIG 0.4gm/kg/day.

Also known as: IVIG

Arm 2: Intravenous injection of immunoglobulin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-70 years old,
• Onset: Recent onset of GBS through the first 2 weeks.

You may not qualify if:

• patients with metabolic disorders, or malignancy,
• other causes of peripheral neuropathy

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, Egypt

Location

Related Publications (10)

• Dornonville de la Cour C, Jakobsen J. Residual neuropathy in long-term population-based follow-up of Guillain-Barre syndrome. Neurology. 2005 Jan 25;64(2):246-53. doi: 10.1212/01.WNL.0000149521.65474.83.

  PMID: 15668421 BACKGROUND

• van Koningsveld R, Steyerberg EW, Hughes RA, Swan AV, van Doorn PA, Jacobs BC. A clinical prognostic scoring system for Guillain-Barre syndrome. Lancet Neurol. 2007 Jul;6(7):589-94. doi: 10.1016/S1474-4422(07)70130-8.

  PMID: 17537676 BACKGROUND

• Fokke C, van den Berg B, Drenthen J, Walgaard C, van Doorn PA, Jacobs BC. Diagnosis of Guillain-Barre syndrome and validation of Brighton criteria. Brain. 2014 Jan;137(Pt 1):33-43. doi: 10.1093/brain/awt285. Epub 2013 Oct 26.

  PMID: 24163275 BACKGROUND

• Walgaard C, Lingsma HF, Ruts L, van Doorn PA, Steyerberg EW, Jacobs BC. Early recognition of poor prognosis in Guillain-Barre syndrome. Neurology. 2011 Mar 15;76(11):968-75. doi: 10.1212/WNL.0b013e3182104407.

  PMID: 21403108 BACKGROUND

• Raphael JC, Chevret S, Hughes RA, Annane D. Plasma exchange for Guillain-Barre syndrome. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD001798. doi: 10.1002/14651858.CD001798.pub2.

  PMID: 22786475 BACKGROUND

• van Doorn PA, Ruts L, Jacobs BC. Clinical features, pathogenesis, and treatment of Guillain-Barre syndrome. Lancet Neurol. 2008 Oct;7(10):939-50. doi: 10.1016/S1474-4422(08)70215-1.

  PMID: 18848313 BACKGROUND

• van Doorn PA. Diagnosis, treatment and prognosis of Guillain-Barre syndrome (GBS). Presse Med. 2013 Jun;42(6 Pt 2):e193-201. doi: 10.1016/j.lpm.2013.02.328. Epub 2013 Apr 28.

  PMID: 23628447 BACKGROUND

• van Nes SI, Vanhoutte EK, van Doorn PA, Hermans M, Bakkers M, Kuitwaard K, Faber CG, Merkies IS. Rasch-built Overall Disability Scale (R-ODS) for immune-mediated peripheral neuropathies. Neurology. 2011 Jan 25;76(4):337-45. doi: 10.1212/WNL.0b013e318208824b.

  PMID: 21263135 BACKGROUND

• Mori M, Kuwabara S, Fukutake T, Hattori T. Intravenous immunoglobulin therapy for Miller Fisher syndrome. Neurology. 2007 Apr 3;68(14):1144-6. doi: 10.1212/01.wnl.0000258673.31824.61.

  PMID: 17404197 BACKGROUND

• Kalita J, Misra UK, Goyal G, Das M. Guillain-Barre syndrome: subtypes and predictors of outcome from India. J Peripher Nerv Syst. 2014 Mar;19(1):36-43. doi: 10.1111/jns5.12050.

  PMID: 24456386 BACKGROUND

MeSH Terms

Conditions

Guillain-Barre Syndrome

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple-blind (participant and investigator, accessor) using closed envelope 2:1 was applied. 5 sessions of plasmapheresis: IVIG 0.4g IVIG/Kg /day for 5 consecutive days. The investigators didn't know what was the type of treatment that patients received and the patient didn't know that there is another line of treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 2 groups of patients with Guillian Barrie syndrome were subjected to plasmapheresis or IVIG by percentage 2:1 respectively according to availability of IVIG

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 3, 2021
• Study Start: September 1, 2021
• Primary Completion: March 2, 2022
• Study Completion: March 3, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Locations

EG (1)