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

• ClinicalTrials.gov Identifier: NCT04951076
• Recruitment Status: Active, not recruiting
• First Posted: July 6, 2021
• Last Update Posted: May 3, 2023
• Sponsor: Bionomics Limited
• Information provided by (Responsible Party): Bionomics Limited

Tracking Information

• First Submitted Date: June 27, 2021
• First Posted Date: July 6, 2021
• Last Update Posted Date: May 3, 2023
• Actual Study Start Date: July 27, 2021
• Estimated Primary Completion Date: July 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Phase 2b Study of BNC210 Tablet Formulation in Adults With Post-Traumatic Stress Disorder (PTSD)
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Post-Traumatic Stress Disorder

Intervention

• 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

• Experimental: BNC210
  Intervention: Drug: BNC210
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: June 27, 2021): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2023
• Estimated Primary Completion Date: July 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom, United States

Administrative Information

• NCT Number: NCT04951076
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Bionomics Limited
• Original Responsible Party: Same as current
• Current Study Sponsor: Bionomics Limited
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Bionomics Limited
• Verification Date: May 2023