Ignite Creation Date:
2024-05-06 @ 8:25 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02733614
Status:
TERMINATED
Last Update Posted:
2021-11-01
First Post:
2016-03-29
Brief Title:
Proof-of-concept Study to Assess the Efficacy and Safety of SRX246 in Adults With PTSD
Sponsor:
Azevan Pharmaceuticals
Organization:
Azevan Pharmaceuticals
Study Overview
Official Title:
A Proof of Concept POC Clinical Trial for Post-Traumatic Stress Disorder PTSD With a First-In-Class Vasopressin 1a Receptor Antagonist SRX246
Status:
TERMINATED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
18-week crossover double-blind randomized placebo controlled proof-of-concept study to assess the efficacy and safety of SRX246 160 mg bid vs placebo in 52 adult veterans and civilians with a primary diagnosis of PTSD Subjects will be randomly assigned in a double-blind fashion to 2 groups in a crossover design The first group will receive SRX246 for 8 weeks followed by 8 weeks of placebo while the second group will receive placebo for 8 weeks followed by 8 weeks of SRX246 Both groups will engage in a 7-day washout period between treatments Subjects will be assessed at baseline and then every 2 weeks during the trial using the CAPS
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