Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422923
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-15
Brief Title:
Effect of NRTX-1001 a Cellular Therapy Product for the Treatment of Refractory Bilateral TLE
Sponsor:
Neurona Therapeutics
Organization:
Neurona Therapeutics
Study Overview
Official Title:
A Study of Inhibitory Interneurons NRTX-1001 for the Treatment of Drug-resistant Bilateral Temporal Lobe Focal Seizures
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to obtain open-label feasibility safety and seizure frequency data in patients with drug-resistant bilateral mesial temporal lobe epilepsy MTLE administered NRTX-1001
Detailed Description:
This is an open-label study of the bilateral intrahippocampal administration of NRTX1001 with the primary endpoint to evaluate safety and a secondary endpoint to evaluate seizure metrics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None