IVIG Versus Plasmapheresis in the Treatment of Guillian Barrie Syndrome Patients

Guillain-Barre Syndrome Clinical Trial

Official title:

IVIG Versus Plasmapheresis and Guillian Barrie Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05104762
• Other study ID #: Guillian Barrie syndrome
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 1, 2021
• Est. completion date: March 3, 2023

Study information

• Verified date: April 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Guillain-Barré syndrome (GBS) is an inflammatory disease of the PNS and is the most common cause of acute flaccid paralysis, with an annual global incidence of approximately 1-2 per 100,000 person-years. Patients with GBS typically present with weakness and sensory signs in the legs that progress to the arms and cranial muscles, although the clinical presentation of the disease is heterogeneous and several distinct clinical variants exist. Diagnosis of GBS is based on the patient's history and neurological, electrophysiological, and cerebrospinal fluid (CSF) examinations. Electrophysiological studies: provide evidence of peripheral nervous system (PNS) dysfunction and can distinguish between the subtypes of GBS: acute inflammatory demyelinating polyradiculoneuropathy (AIDP), acute motor axonal neuropathy (AMAN), and acute motor-sensory axonal neuropathy (AMSAN). Disease progression can be rapid, and most patients with GBS reach their maximum disability within 2 weeks. About 20% of patients with GBS develop respiratory failure and require mechanical ventilation. Cardiac arrhythmias and blood pressure instability can occur owing to the involvement of the autonomic nervous system. Immunomodulatory therapy should be started if patients are unable to walk independently for 10 m. Evidence on treatment efficacy in patients who can still walk independently is limited, but treatment should be considered, especially if these patients display rapidly progressive weakness or other severe symptoms such as autonomic dysfunction, bulbar failure, or respiratory insufficiency. Clinical trials have demonstrated a treatment effect for intravenous immunoglobulin (IVIg) when started within 2 weeks of the onset of weakness and for plasma exchange when started within 4 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: March 3, 2023
• Est. primary completion date: March 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age: 18-70 years old,

• Onset: Recent onset of GBS through the first 2 weeks.

• Gender: Male or Female Inclusion Criteria.

Exclusion Criteria:

• patients with metabolic disorders, or malignancy,

• other causes of peripheral neuropathy

Related Conditions & MeSH terms

• Guillain-Barre Syndrome
• Syndrome

Intervention

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

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

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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	Neurophysiological study: Distal latency in mill second, Nerve conduction velocities in Meter/second, and F-wave latency mill second	Neurophysiological study neurophysiological study pre- and after 3 months change of degree of affection and improvement in latency in nerve conduction m/ sec. amplitude m/v , velocity of nerve /s conduction and F-wave of both upper limbs and lower limbs	the change in points from baseline assessment score to 3 months follow up assessment score.