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

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ClinicalTrials.gov Identifier: NCT04951076
Recruitment Status : Recruiting
First Posted : July 6, 2021
Last Update Posted : October 4, 2021
Sponsor:
Information provided by (Responsible Party):
Bionomics Limited

Tracking Information
First Submitted Date  ICMJE June 27, 2021
First Posted Date  ICMJE July 6, 2021
Last Update Posted Date October 4, 2021
Actual Study Start Date  ICMJE July 27, 2021
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2021)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2021)
  • 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)
  • 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)
  • PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: 12 weeks ]
    Change from Baseline on patient-reported symptoms of PTSD
  • Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 12 Weeks ]
    Change from Baseline on Investigator-rated symptoms of depression
  • Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: 12 Weeks ]
    Change from Baseline on Investigator-rated symptoms of anxiety
  • Clinician Global Impression (CGI) [ Time Frame: 12 weeks ]
    Change from Baseline on Investigator-rated global functioning
  • Patient Global Impression (PGI) [ Time Frame: 12 weeks ]
    Change from Baseline on patient-reported global functioning
  • Insomnia Severity Index (ISI) [ Time Frame: 12 weeks ]
    Change from Baseline on patient-reported sleep quality
  • Sheehan Disability Scale (SDS) [ Time Frame: 12 weeks ]
    Change from Baseline on patient-reported social functioning
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2b Study of BNC210 Tablet Formulation in Adults With Post-Traumatic Stress Disorder (PTSD)
Official Title  ICMJE 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)
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 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Post-Traumatic Stress Disorder
Intervention  ICMJE
  • Drug: BNC210
    BNC210 900 mg twice daily (b.i.d.) for 12 weeks
  • Drug: Placebo
    Placebo twice daily (b.i.d.) for 12 weeks
Study Arms  ICMJE
  • Experimental: BNC210
    Intervention: Drug: BNC210
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 27, 2021)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2023
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BNC210 Clinical Studies Bionomics Limited +61 8 8150 7400 bnc210clinicalstudies@bionomics.com.au
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04951076
Other Study ID Numbers  ICMJE BNC210.012
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bionomics Limited
Study Sponsor  ICMJE Bionomics Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bionomics Limited
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP