Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-01-05 @ 5:46 PM
Study NCT ID:
NCT03350035
Status:
COMPLETED
Last Update Posted:
2023-03-09
First Post:
2017-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus
Sponsor:
Marinus Pharmaceuticals
Organization:
Study Overview
Official Title:
A Double-Blind Randomized, Placebo Controlled Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus
Status:
COMPLETED
Status Verified Date:
2023-03
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 study will evaluate the effectiveness and safety of an investigational drug, IV ganaxolone, as adjunctive therapy to standard of care to treat subjects with status epilepticus.
Detailed Description:
This is a double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, and efficacy of adjunctive IV ganaxolone in subjects with SE.
Study drug will be added to standard of care before IV anesthetic during the treatment of SE.
Subjects will be screened for inclusion/exclusion criteria prior to receiving study drug as adjunctive therapy by continuous IV. Subject's will be followed up for 3 weeks post-treatment.
Subjects who are known to be at risk for SE may be consented and/or assented prior to an SE event.
Study drug will be added to standard of care before IV anesthetic during the treatment of SE.
Subjects will be screened for inclusion/exclusion criteria prior to receiving study drug as adjunctive therapy by continuous IV. Subject's will be followed up for 3 weeks post-treatment.
Subjects who are known to be at risk for SE may be consented and/or assented prior to an SE event.
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?: