Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00442104
Status:
TERMINATED
Last Update Posted:
2024-05-28
First Post:
2007-02-27
Brief Title:
Open-label Extension to Protocol 1042-0500
Sponsor:
Marinus Pharmaceuticals
Organization:
Marinus Pharmaceuticals
Study Overview
Official Title:
An Open-label Clinical Study to Evaluate the Safety and Antiepileptic Activity of Ganaxolone in Treatment of Patients Diagnosed With Infantile Spasms
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsors decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To allow open-label extension to patients who have completed Protocol 1042-0500
Detailed Description:
Patient should have completed all scheduled clinical study visits in the double blind controlled trial Protocol 1042-0500 and have been deemed eligible had a response to treatment by the Investigator Male or female with a diagnosis of IS with a video EEG vEEG recording confirming the diagnosis
There will be a total of 14 visits over 99or-1week A 24-hr vEEG is only required if the subject has been spasm-free for more than 24-hrs
There will be a total of 14 visits over 99or-1week A 24-hr vEEG is only required if the subject has been spasm-free for more than 24-hrs
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Amend 6 US | None | None | None |
| Amend 5 ROW | None | None | None |