Status:
NOT_YET_RECRUITING
Efgartigimod for Stiff Person Syndrome (ESPS)
Lead Sponsor:
University of South Florida
Conditions:
Stiff-Person Syndrome
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Age 18-80, men and women, capable of giving informed consent.
- Must have unexplained stiffness of limb and axial (trunk) muscles and involuntary striated muscle spasms.
- DSI and HHS must be \>=2 (to allow for detection of improvement).
- Presence of serum (or CSF) anti-GAD antibodies regardless of titers.
- Stable dosage for at least two months before screening visit with antispasmodics (muscle relaxants, benzodiazepines, baclofen).
- Women with children bearing potential must be willing to use highly effective contraception method during and for a minimum of 90 days after the last dose of IP.
Exclusion
- 1\. Exclusionary conditions:
- 1a. type 1 DM
- 1b. Cancer, except basal cell skin cancer
- 1c. Infections: HIV, Hepatitis B or C, clinically significant active infection not sufficiently resolved in the investigator's opinion
- 1d. Serum IgG (\<6 g/L) at screening
- 1e. pregnancy/breast feeding. 2. Exclusionary medications: rituximab within 6 months of screening. 3. IVIG or PLEX treatment 4 weeks prior to screening. 4. History of any type of solid organ or bone marrow transplant.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06528392
Start Date
April 1 2025
End Date
December 31 2027
Last Update
April 11 2025
Active Locations (1)
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1
University of South Florida, Carol and Frank Morsani Center for Advanced Healthcare
Tampa, Florida, United States, 33612