Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2025-12-26 @ 2:01 AM
Study NCT ID:
NCT05481905
Status:
WITHDRAWN
Last Update Posted:
2023-07-06
First Post:
2022-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ENACT: A Study of ENX-101 as Adjunctive Treatment in Patients With Focal Seizures
Sponsor:
Engrail Therapeutics INC
Organization:
Study Overview
Official Title:
The ENACT Trial: A Randomized, Double-blind, Placebo-controlled Adjunctive Treatment Trial to Evaluate the Efficacy and Safety of ENX-101 in Patients With Focal (Partial Onset) Seizures
Status:
WITHDRAWN
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENACT
Brief Summary:
The ENACT trial is designed to evaluate the efficacy and safety of ENX-101 administered adjunctively to current therapy in reducing seizure frequency in patients diagnosed with focal (partial onset) epilepsy and treated with 1 to 4 antiseizure medications yet still experiencing seizures.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: