Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528392
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Efgartigimod for Stiff Person Syndrome ESPS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efgartigimod for Stiff Person Syndrome ESPS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESPS
Brief Summary:
The goal of this clinical trial is to examine the proportion of patients with stiff person syndrome with no worsening in stiffness andor 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None