Clinical Trial

Efgartigimod for Stiff Person Syndrome (ESPS)

Study acronym: ESPS
Not Yet Recruiting Phase 2
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Summary
The goal of this clinical trial is to examine the proportion of patients with stiff person syndrome with no worsening in stiffness and/or spasms while on efgartigimod-hyaluronidase (EFD) when compared to their current treatment. The main questions it aims to answer are: * proportion of patients with stiff person syndrome with no worsening in DSI and HSS scores * whether there are changes in laboratory values, vital signs, electrocardiogram, or depression, and suicide risk during the trial, as well as the incidence of any adverse events. Participants will come to the clinic up to 18 times and have up to 5 phone call visits during the course of the trial. During these visits a variety of measures will be collected, including blood samples, neurological and physical exams, patient reported outcomes on stiffness, spasms, depression, and suicide risk.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-07-25.
Trial Details
NCT Number NCT06528392
Lead Sponsor University of South Florida
Conditions Stiff-Person Syndrome
Enrollment 10 participants
Start Date 2025-04-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-04-11