Ignite Creation Date:
2024-05-05 @ 11:28 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01339689
Status:
COMPLETED
Last Update Posted:
2022-12-29
First Post:
2011-04-19
Brief Title:
Ganaxolone in Posttraumatic Stress Disorder PTSD
Sponsor:
Marinus Pharmaceuticals
Organization:
Marinus Pharmaceuticals
Study Overview
Official Title:
A Proof-of-Concept Double-blind Randomized Placebo-controlled Study of Ganaxolone in Posttraumatic Stress Disorder
Status:
COMPLETED
Status Verified Date:
2022-11
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 Phase 2 proof-of-concept study is a double-blind randomized placebo-controlled 15-week investigation of ganaxolone versus placebo for the treatment of Posttraumatic Stress Disorder PTSD Up to 120 participants will be enrolled and randomized to receive either ganaxolone or placebo for 6 weeks After 6 weeks of randomized treatment all participants will continue for 6 weeks on ganaxolone The aim of the study is to assess the efficacy of ganaxolone compared to placebo for the treatment of PTSD symptoms after 6 weeks of treatment using the Clinician-Administered PTSD Rating Scale CAPS The second aim of the study is to evaluate the safety and tolerability of ganaxolone in the PTSD population
Detailed Description:
None
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