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

August 17, 2023 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 PTSD symptom severity as measured by CAPS-5 Total Symptom Severity Scores.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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 (i.e., 3 weeks after their last study intervention is administered).

Study Type

Interventional

Enrollment (Actual)

212

Phase

  • 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 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

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 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
Intervention / Treatment
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

Outcome Measure
Measure Description
Time Frame
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Time Frame: 12 weeks
Change from Baseline on Investigator-rated symptoms of PTSD (total symptom severity scores)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Time Frame: 12 Weeks
Change from Baseline on Investigator-rated symptom clusters of PTSD (symptom cluster scores)
12 Weeks
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Time Frame: 12 weeks
Response rate and remission rate using Investigator-rated symptoms of PTSD (total symptom severity scores)
12 weeks
PTSD Checklist for DSM-5 (PCL-5)
Time Frame: 12 weeks
Change from Baseline on patient-reported symptoms of PTSD
12 weeks
Montgomery Asberg Depression Rating Scale (MADRS)
Time Frame: 12 Weeks
Change from Baseline on Investigator-rated symptoms of depression
12 Weeks
Hamilton Anxiety Rating Scale (HAM-A)
Time Frame: 12 Weeks
Change from Baseline on Investigator-rated symptoms of anxiety
12 Weeks
Clinician Global Impression (CGI)
Time Frame: 12 weeks
Change from Baseline on Investigator-rated global functioning
12 weeks
Patient Global Impression (PGI)
Time Frame: 12 weeks
Change from Baseline on patient-reported global functioning
12 weeks
Insomnia Severity Index (ISI)
Time Frame: 12 weeks
Change from Baseline on patient-reported sleep quality
12 weeks
Sheehan Disability Scale (SDS)
Time Frame: 12 weeks
Change from Baseline on patient-reported social functioning
12 weeks

Collaborators and Investigators

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

Sponsor

Bionomics Limited

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)

July 27, 2021

Primary Completion (Actual)

July 25, 2023

Study Completion (Actual)

August 14, 2023

Study Registration Dates

First Submitted

June 27, 2021

First Submitted That Met QC Criteria

June 27, 2021

First Posted (Actual)

July 6, 2021

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 17, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BNC210.012

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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