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

January 15, 2025 updated by: Bionomics Limited

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
212

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • Barnsley, United Kingdom, S75 3DL
        • ATTUNE Study Clinical Trial Site
      • Blackpool, United Kingdom, FY2 0JH
        • ATTUNE Study Clinical Trial Site
      • Cannock, United Kingdom, WS11 0BN
        • ATTUNE Study Clinical Trial Site
      • Leeds, United Kingdom, LS10 1DU
        • ATTUNE Study Clinical Trial Site
      • Liverpool, United Kingdom, L34 1BH
        • ATTUNE Study Clinical Trial Site
      • Manchester, United Kingdom, M13 9NQ
        • ATTUNE Study Clinical Trial Site
      • Stockton-on-Tees, United Kingdom, TS17 6EW
        • ATTUNE Study Clinical Trial Site
  • United States
    • California
      • Bellflower, California, United States, 90706
        • ATTUNE Study Clinical Trial Site
      • Beverly Hills, California, United States, 90210
        • ATTUNE Study Clinical Trial Site
      • Colton, California, United States, 92324
        • ATTUNE Study Clinical Trial Site
      • Oceanside, California, United States, 92056
        • ATTUNE Study Clinical Trial Site
      • Orange, California, United States, 92868
        • ATTUNE Study Clinical Trial Site
      • Temecula, California, United States, 92591
        • ATTUNE Study Clinical Trial Site
    • Florida
      • Jacksonville, Florida, United States, 32256
        • ATTTUNE Study Clinical Trial Site
      • Lauderhill, Florida, United States, 33319
        • ATTUNE Study Clinical Trial Site
      • Miami Lakes, Florida, United States, 33016
        • ATTUNE Study Clinical Trial Site
      • Orlando, Florida, United States, 32801
        • ATTUNE Study Clinical Trial Site
    • Kansas
      • Overland Park, Kansas, United States, 66221
        • ATTUNE Study Clinical Trial Site
      • Prairie Village, Kansas, United States, 66208
        • ATTUNE Study Clinical Trial Site
    • Massachusetts
      • New Bedford, Massachusetts, United States, 02740
        • ATTUNE Study Clinical Trial Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • ATTUNE Study Clinical Trial Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • ATTUNE Study Clinical Trial Site
      • Cherry Hill, New Jersey, United States, 08002
        • ATTUNE Study Clinical Trial Site
    • New York
      • Cedarhurst, New York, United States, 11516
        • ATTUNE Study Clinical Trial Site
      • Staten Island, New York, United States, 10312
        • ATTUNE Study Clinical Trial Site
    • Ohio
      • North Canton, Ohio, United States, 44720
        • ATTUNE Study Clinical Trial Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73106
        • ATTUNE Study Clinical Trial Site
    • Pennsylvania
      • West Chester, Pennsylvania, United States, 19380
        • ATTUNE Study Clinical Trial Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • ATTUNE Study Clinical Trial Site
    • Texas
      • Austin, Texas, United States, 78737
        • ATTUNE Study Clinical Trial Site
      • Dallas, Texas, United States, 75231
        • ATTUNE Study Clinical Trial Site
    • Utah
      • Draper, Utah, United States, 84020
        • ATTUNE Study Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Placebo twice daily (b.i.d.) for 12 weeks
Experimental: BNC210
Drug: BNC210
BNC210 900 mg twice daily (b.i.d.) for 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline, 4 weeks, 8 weeks,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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion B Symptom Cluster Scores After 12 Weeks
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Criterion B (Intrusive Thoughts) is a 5-item sub section of the CAPS-5 scale that assesses intrusion symptoms associated with the traumatic event(s) of PTSD, with each item rated on a scale from 0 (not present) to 4 (extreme / incapacitating). Scores range from 0 to 20, with higher scores indicating greater severity of intrusion symptoms.
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
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Criterion C (Avoidance) is a 2-item sub section of the CAPS-5 scale that assesses avoidance of stimuli associated with the traumatic event(s) of PTSD, with each item rated on a scale from 0 (not present) to 4 (extreme / incapacitating). Scores range from 0 to 8, with higher scores indicating greater severity of avoidance symptoms.
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
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Criterion D (Negative Alterations in Cognitions and Mood) is a 7-item sub section of the CAPS-5 scale that assesses negative alterations in cognitions and mood associated with the traumatic event(s) of PTSD, with each item rated on a scale from 0 (not present) to 4 (extreme / incapacitating). Scores range from 0 to 28, with higher scores indicating greater severity of negative alterations in cognitions and mood symptoms.
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
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Criterion E (Arousal and Reactivity) is a 6-item sub section of the CAPS-5 scale that assesses marked alterations in arousal and reactivity associated with the traumatic event(s) of PTSD, with each item rated on a scale from 0 (not present) to 4 (extreme / incapacitating). Scores range from 0 to 24, with higher scores indicating greater severity of arousal and reactivity symptoms.
Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Montgomery Asberg Depression Rating Scale (MADRS) Scores After 12 Weeks
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks
The MADRS is a 10-item clinician-rated questionnaire to measure the presence and severity of depressive episodes. Each item is rated on a scale of 0 to 6. The score from each item is combined into a total score ranging from 0 to 60, with higher scores indicating greater severity of depressive episodes.
Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Hamilton Anxiety Rating Scale (HAM-A) Scores After 12 Weeks
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks
The HAM-A is an interview questionnaire that measures severity of anxiety symptoms based on 14 parameters, including anxious mood, tension, fears, insomnia, somatic complaints and behavior during the interview. Each parameter is rated on a scale of 0 (not present) to 4 (very severe). The score from each parameter is combined into a total score. Scores range from 0 to 56, with higher scores indicating greater severity of anxiety symptoms.
Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Clinician Global Impression - Severity (CGI-S) Scale Scores After 12 Weeks
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks
The CGI-S is a rating scale designed to assess the overall severity of the participant's symptoms. Severity is rated on a scale from 1 (normal, not at all ill) to 7 (among the most extremely ill of participants), with a higher score indicating greater severity of symptoms.
Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Patient Global Impression - Severity (PGI-S) Scale Scores After 12 Weeks
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks

Change from Baseline on patient-reported global functioning

The PGI-S is a patient self-reported counterpart of the CGI-S designed to assess the patient's impression of their perceived severity of overall symptoms.Severity is rated on the PGI-S from 1 (normal) to 6 (very severe), with a higher score indicating greater severity of symptoms.
Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Insomnia Severity Index (ISI) Scores After 12 Weeks
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks
The ISI is a brief self-report instrument measuring both nocturnal and diurnal symptoms of insomnia. The ISI comprises seven items, each scored from 0 to 4. The scores from each of the 7 questions are added up to get a total score of 0 to 28, with a higher score indicating a higher level of symptom severity.
Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Sheehan Disability Scale (SDS) Scores After 12 Weeks
Time Frame: Baseline, 4 weeks, 8 weeks,12 weeks
The SDS is a rating scale designed to measure impairment in three domains: work/school, social life, and family life/home responsibilities. Each item is rated on a scale of 0 (not at all) to 10 (extremely), for a total score of 0 to 30, with a higher score indicating a higher degree of impairment.
Baseline, 4 weeks, 8 weeks,12 weeks
Change From Baseline on PTSD Checklist for DSM-5 (PCL-5) Scores After 12 Weeks
Time Frame: Baseline, 12 weeks
The PCL-5 is a 20-item self-report assessment of the 20 DSM-5 symptoms of PTSD. Each symptom is rated on a scale from 0 (not at all) to 4 (extremely). Scores range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.
Baseline, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bionomics Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 25, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 14, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BNC210.012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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