Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596291
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Dose Escalation Study of EG110A Administered by Intradetrusor Injections to Adults with Neurogenic Detrusor Overactivity-related Incontinence Following Spinal Cord Injury Who Regularly Perform Clean Intermittent Catheterization
Sponsor:
None
Organization:
None
Study Overview
Official Title:
First-In-Human Phase 1b2a Dose Escalation Study of EG110A Administered by Intradetrusor Injections to Adult Participants with Neurogenic Detrusor Overactivity-related Incontinence Following Spinal Cord Injury Who Regularly Perform Clean Intermittent Catheterization
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
This is a first-in-human Phase 1b2a open-label dose-escalation study of a single treatment course consisting of multiple intradetrusor injections of EG110A in male and female adult participants with Neurogenic Detrusor Overactivity NDO-related incontinence following Spinal Cord Injury SCI who have persistent incontinence after standard of care therapy and who perform Clear Intermittent Catheterization CIC on a regular basis
Detailed Description:
This first-in-human clinical study performed in SCI participants with Urinary Incontinence UI due to NDO and an inadequate response to current therapy will evaluate the safety and tolerability of EG110A and explore the potential doses for further clinical development The present clinical study will also investigate the efficacy of EG110A via data collected in a bladder diary and via urodynamic assessments
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