Landscape of Guillain-Barré Syndrome Interventional Clinical Trials

Abstract

Introduction: Guillain-Barré syndrome (GBS) is an immune-mediated polyradiculoneuropathy that remains a debilitating disease despite medical treatment. Numerous challenges still exist, including the development of disease-modifying therapies that can improve prognosis, particularly in patients with poor prognostic outcomes. In this study, we explored clinical trials related to GBS, analyzed the trial characteristics, suggested some ideas for improvement, and discussed recent advances.

Methods: On December 30, 2021, the authors searched ClinicalTrials.gov for all interventional and therapeutic clinical trials related to GBS, without any restrictions on the date or location. Trial characteristics including trial duration, location, phase, sample size, and publications were retrieved and analyzed.

Results: Twenty-one trials fulfilled the selection criteria. Clinical trials were conducted in 11 different countries, most of them occurring in Asia. On average, the trial duration across the phases was around 2 years. About two-thirds of trials were completed, and 39% of trials were in the early phases (1 and 2). Only 24% of all trials and 60% of completed trials have publications in this study.

Conclusions: The study revealed a low number of trials, lack of geographic diversity, scanty enrollment of patients, and paucity of clinical trial duration and publications regarding GBS clinical trials. Optimization of GBS trials is fundamental to achieving effective therapies for this disease.

Trial registration: ClinicalTrials.gov NCTID-an id NCTID to re NCT00411216 NCT01306578.