Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05818553
Status:
RECRUITING
Last Update Posted:
2024-01-10
First Post:
2023-03-17
Brief Title:
A Clinical Trial of PRAX-562 in Subjects With Developmental and Epileptic Encephalopathies DEE
Sponsor:
Praxis Precision Medicines
Organization:
Praxis Precision Medicines
Study Overview
Official Title:
A Phase 2Double-BlindRandomized Clinical Trial to Explore the SafetyTolerabilityEfficacy and Pharmacokinetics of PRAX-562 in Pediatric Participants With Developmental and Epileptic Encephalopathies Followed by Open-Label ExtensionOLE
Status:
RECRUITING
Status Verified Date:
2024-01
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:
EMBOLD
Brief Summary:
This is a Phase 2 double-blind randomized clinical trial to explore the safety tolerability efficacy and pharmacokinetics of PRAX-562 in pediatric participants who have seizures associated with early-onset SCN2A-DEE and SCN8A-DEE
Detailed Description:
None
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