Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377930
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-17
Brief Title:
Study Evaluating the Safety and Efficacy of RAP-219 in Adult Participants With Refractory Focal Epilepsy
Sponsor:
Rapport Therapeutics Inc
Organization:
Rapport Therapeutics Inc
Study Overview
Official Title:
A Phase 2A Multicenter Open-label Study Evaluating the Safety and Efficacy of RAP-219 in Adult Participants With Refractory Focal Epilepsy
Status:
RECRUITING
Status Verified Date:
2024-10
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 is a clinical research study for an investigational drug called RAP-219 in patients with Refractory Focal Epilepsy This study is being conducted to determine if RAP-219 works and is safe in patients with Refractory Focal Epilepsy
Detailed Description:
This is a Phase 2A proof-of-concept multi-center open-label study designed to evaluate the efficacy safety tolerability and PKPD relationship of RAP-219 in adult participants with refractory focal epilepsy The activity of RAP-219 will be assessed in approximately 20 participants treated with the RNS system
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