NCT04951076|CompletedPhase 2ResultsFDA Drug

A Phase 2b Study of BNC210 Tablet Formulation in Adults With Post-Traumatic Stress Disorder (PTSD)

ATTUNE

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)

Bionomics Limited ClinicalTrials.gov

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1 other identifier

BNC210.012

Study Type

interventional

Target

212

Locations

2 countries

Sites

Timeline

RegisteredJul 2021

StartedJul 2021

CompletionAug 2023

Brief Summary

The purpose of this study is to assess the effects of BNC210 compared to placebo on Post-Traumatic Stress Disorder (PTSD) symptom severity as measured by the Clinician Administered PTSD scale for The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) Total Symptom Severity Scores.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

212

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jul 2021

Geographic Reach

2 countries

32 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

First Submitted

Initial submission to the registry

June 27, 2021

Completed

9 days until next milestone

First Posted

Study publicly available on registry

July 6, 2021

Completed

21 days until next milestone

Study Start

First participant enrolled

July 27, 2021

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2023

Completed

20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2023

Completed

1.5 years until next milestone

Results Posted

Study results publicly available

February 6, 2025

Completed

Last Updated

February 6, 2025

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

June 27, 2021

Results QC Date

December 17, 2024

Last Update Submit

January 15, 2025

Conditions

Post-Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

Change From Baseline on the Clinician Administered Post-Traumatic Stress Disorder (PTSD) Scale for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) Total Symptom Severity Scores After 12 Weeks
The CAPS-5 is a 30-item structured interview used to diagnose PTSD and assess PTSD symptoms over the past month. Information about the frequency and intensity of each item is combined into a severity rating, and the CAPS-5 total symptom severity score is calculated by adding the severity scores for the 20 PTSD symptoms in the DSM-5. Scores range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.
Baseline, 4 weeks, 8 weeks,12 weeks

Secondary Outcomes (11)

Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion B Symptom Cluster Scores After 12 Weeks
Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion C Symptom Cluster Scores After 12 Weeks
Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion D Symptom Cluster Scores After 12 Weeks
Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion E Symptom Cluster Scores After 12 Weeks
Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Montgomery Asberg Depression Rating Scale (MADRS) Scores After 12 Weeks
Baseline, 4 weeks, 8 weeks, 12 weeks
+6 more secondary outcomes

Study Arms (2)

BNC210

EXPERIMENTAL

Drug: BNC210

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BNC210DRUG

BNC210 900 mg twice daily (b.i.d.) for 12 weeks

BNC210

PlaceboDRUG

Placebo twice daily (b.i.d.) for 12 weeks

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Participants with a current diagnosis of PTSD as defined by the CAPS-5 for DSM-5, with a CAPS-5 Total Symptom Severity Score of ≥30 at Screening and Baseline and no \>25% decrease in Score from Screening to Baseline
The index trauma event must have occurred in adulthood, i.e., when the participant was ≥18 years of age
Suitable contraception use in line with protocol requirements
Ability to swallow tablets

You may not qualify if:

A period of less than 6 months since the index trauma event
Current and ongoing exposure to the trauma that caused the PTSD
Complex PTSD
Severe depression as measured by a score of ≥ 35 on the Montgomery Asberg Depression Rating Scale (MADRS)
Borderline personality disorder, bipolar disorder and other psychotic disorders
Use of antidepressant medications within 30 days (fluoxetine within 90 days) of Screening. The use of alprazolam, flunitrazepam and chronic daily use of other benzodiazepines within 90 day of Screening.
Failed more than three trials of antidepressant medication(s) prescribed for the treatment of PTSD.
Concurrent trauma-based psychotherapy such as Cognitive Behavior Therapy, Prolonged Exposure Therapy, Eye Movement Desensitization and Reprocessing Therapy. Participants may however continue to receive supportive counseling that has been in place for a minimum of three months prior to Screening.
Any moderate or severe substance use disorder in the past 12 months
Any clinically significant medical history or findings as determined by the Investigator that could interfere with the objectives of the study or put the participant at risk

Contact the study team to confirm eligibility.