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

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

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)

NCT04951076•Bionomics Limited

View on ClinicalTrials.gov

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.

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 1:1 ratio to receive either BNC210 900 mg twice daily (b.i.d.) or matched placebo. Participants will then complete 12 weeks of treatment with their allocated study intervention. Participants will return to their study site at 2-weekly intervals to complete study assessments. Participants are then requested to attend a Follow-up visit at Week 15 (i.e., 3 weeks after their last study intervention is administered).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•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

Exclusion Criteria

•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

Locations (32)

ATTUNE Study Clinical Trial Site

Bellflower, California, United States

ATTUNE Study Clinical Trial Site

Beverly Hills, California, United States

ATTUNE Study Clinical Trial Site

Colton, California, United States

ATTUNE Study Clinical Trial Site

Oceanside, California, United States

ATTUNE Study Clinical Trial Site

Orange, California, United States

ATTUNE Study Clinical Trial Site

Temecula, California, United States

ATTTUNE Study Clinical Trial Site

Jacksonville, Florida, United States

ATTUNE Study Clinical Trial Site

Lauderhill, Florida, United States

ATTUNE Study Clinical Trial Site

Miami Lakes, Florida, United States

ATTUNE Study Clinical Trial Site

Orlando, Florida, United States

Key Dates

Start Date

July 27, 2021

Primary Completion Date

July 25, 2023

Completion Date

August 14, 2023

Last Updated

February 6, 2025

Enrollment

212

ACTUAL participants

Conditions

Post-Traumatic Stress Disorder

Interventions

BNC210

DRUG

Placebo

DRUG

Sponsors

Lead Sponsor

Bionomics Limited

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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