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NCT06528392 · ClinicalTrials.gov registry record · Phase 2
Efgartigimod for Stiff Person Syndrome (ESPS)
A Phase 2 study, sponsored by University of South Florida.
- Not yet
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT06528392: Clinical Trial Phase 2 study, sponsored by University of South Florida.
NCT06528392 is a Phase 2 study that has not yet begun recruiting, run by University of South Florida. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06528392, a Phase 2 study, has not yet begun recruiting, sponsored by University of South Florida.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study 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.
Primary Outcome
DSI is a validated indicator or stiffness. Scores range from 0 to 6 and reflect the extent of stiffness. One point is given for stiffness in each of the following areas: lower trunk, upper trunk, legs, arms, face and abdomen.
Interventions
- BIOLOGICAL Efgartigimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-04-01 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What is known before NCT06528392 opens enrollment
NCT06528392 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Efgartigimod is the first listed.
NCT06528392 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06528392 about?
NCT06528392 is a clinical study titled "Efgartigimod for Stiff Person Syndrome (ESPS)". 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 wit...
What is the current status of trial NCT06528392?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2025-04-01. Estimated completion is 2027-12-31.
What interventions are being tested in trial NCT06528392?
The interventions under investigation include: Efgartigimod (BIOLOGICAL).
Who is sponsoring clinical trial NCT06528392?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06528392's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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