Ignite Creation Date:
2024-05-06 @ 4:21 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04951076
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2021-06-27
Brief Title:
A Phase 2b Study of BNC210 Tablet Formulation in Adults With Post-Traumatic Stress Disorder PTSD
Sponsor:
Bionomics Limited
Organization:
Bionomics Limited
Study Overview
Official Title:
A Phase 2b Randomized Double Blind Two Arm Study to Investigate the Effects of BNC210 Tablet Formulation Compared to Placebo in Adults With Post-Traumatic Stress Disorder PTSD
Status:
COMPLETED
Status Verified Date:
2023-08
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:
ATTUNE
Brief Summary:
The purpose of this study is to assess the effects of BNC210 compared to placebo on PTSD symptom severity as measured by CAPS-5 Total Symptom Severity Scores
Detailed Description:
This is a randomized double-blind placebo-controlled parallel group multi-center study with a 12 week 2-arm treatment period Participants will attend a Screening visit within 3 weeks before randomization to confirm eligibility Approximately 200 participants will be randomized using a 11 ratio to receive either BNC210 900 mg twice daily bid or matched placebo Participants will then complete 12 weeks of treatment with their allocated study intervention Participants will return to their study site at 4-weekly intervals to receive study intervention and complete safety and efficacy assessments Participants are then requested to attend a Follow-up visit at Week 15 ie 3 weeks after their last study intervention is administered
Study Oversight
Has Oversight DMC:
None
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?:
None