Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-03-12 @ 6:24 AM
Study NCT ID:
NCT01002820
Status:
COMPLETED
Last Update Posted:
2022-09-07
First Post:
2009-10-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Treatment Use Protocol for Subjects Continuing on From the Open-label Extension 0601
Sponsor:
Marinus Pharmaceuticals
Organization:
Study Overview
Official Title:
A Treatment Protocol for Ganaxolone as add-on Therapy in Adult Patients With Uncontrolled Partial-onset Seizures Deriving Benefit From Protocol 1042-0601
Status:
COMPLETED
Status Verified Date:
2022-05
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:
0602
Brief Summary:
This study is designed to provide ganaxolone to those patients deriving significant benefit from current treatment in protocol 1042-0601.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: