Evaluating Efgartigimod in Patients With Guillain-Barré Syndrome

Status Not yet recruiting

Clinical Trial Summary

The goal of this clinical trial is to evaluate the safety and effectiveness of Efgartigimod in patients with Guillain-Barre syndrome (GBS). The main questions it aims to answer are: - Is Efgartigimod a safe treatment option for GBS patients? - Does treatment with Efgartigimod improve patient outcomes? In addition to standard-of-care procedures and assessments, participants will: - Undergo seven blood draws during hospitalization and in four follow-up study visits to evaluate the concentration of neurofilament light chain, a protein that is elevated in patients with Guillain-Barré syndrome. The presence of neurofilament light chain is believed to be indicative of damage to the nervous system, with higher levels resulting from greater damage. - Complete the Columbia Suicide Severity Rating Scale (C-SSRS) to monitor any suicidal ideation or behaviors during the course of the study.

Clinical Trial Description

The following procedures/assessments are standard-of-care for Guillain-Barré syndrome. They will not be performed solely for research purposes in this study, but the study team will use select results from them to draw conclusions related to this research: - The study doctor or study staff will ask you about your medical history and any changes to your medications - You will have a physical examination - Your vital signs, including blood pressure, pulse rate, breathing rate, body temperature, and weight will be measured - You will have an electrocardiogram (ECG) - Pulmonary function testing, including forced vital capacity (FVC), maximal inspiratory pressure (MIP), and maximal expiratory pressure (MEP) will be performed - Blood samples will be drawn to evaluate disease progression and safety/efficacy of treatment - You will undergo a lumbar puncture, commonly referred to as a spinal tap, to collect cerebrospinal fluid (CSF) for analysis - Nerve conduction studies (NCS) will be performed - Outcome assessments including the GBS Disability Scale (GBS-DS), Neuropsychological Impairment Scale (NIS), and Inflammatory Rasch-built Overall Disability Scale (I-RODS) will be performed ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05701189
Study type	Interventional
Source	University of Pennsylvania
Contact	Kelsey Moulton
Phone	267-593-9459
Email	kelsey.moulton@pennmedicine.upenn.edu
Status	Not yet recruiting
Phase	Phase 2
Start date	May 2024
Completion date	May 2027

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.