TY - JOUR
T1 - Landscape of Guillain-Barré Syndrome Interventional Clinical Trials
AU - Saleh, Mustafa
AU - Boukhdoud, Mona
AU - Boukhdoud, Hayam
AU - Al Zein, Mohammad
AU - Salameh, Pascale
N1 - Publisher Copyright:
© 2023 Lippincott Williams and Wilkins. All rights reserved.
PY - 2023/3/1
Y1 - 2023/3/1
N2 - 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.
AB - 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.
KW - clinical trials
KW - Guillain-Barré syndrome
KW - intervention
KW - IVIG
KW - nervous system
KW - PE
UR - http://www.scopus.com/inward/record.url?scp=85148679223&partnerID=8YFLogxK
U2 - 10.1097/CND.0000000000000441
DO - 10.1097/CND.0000000000000441
M3 - Article
C2 - 36809199
AN - SCOPUS:85148679223
SN - 1522-0443
VL - 24
SP - 119
EP - 129
JO - Journal of Clinical Neuromuscular Disease
JF - Journal of Clinical Neuromuscular Disease
IS - 3
ER -