Phase 2
N=212
A Phase 2b Study of BNC210 Tablet Formulation in Adults With Post-Traumatic Stress Disorder (PTSD)
Post-Traumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04951076 ↗Enrolled (actual)
212
Serious AEs
1.0%
Results posted
Feb 2025
Primary outcome: Primary: 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 — -20.08; -16.05 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BNC210 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bionomics Limited
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-20.08; -16.05 | — |
| SECONDARY Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion B Symptom Cluster Scores After 12 Weeks |
-5.72; -4.40 | — |
| SECONDARY Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion C Symptom Cluster Scores After 12 Weeks |
-2.28; -1.79 | — |
| SECONDARY Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion D Symptom Cluster Scores After 12 Weeks |
-7.77; -5.98 | — |
| SECONDARY Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion E Symptom Cluster Scores After 12 Weeks |
-4.35; -3.98 | — |
| SECONDARY Change From Baseline on Montgomery Asberg Depression Rating Scale (MADRS) Scores After 12 Weeks |
-9.01; -5.82 | — |
| SECONDARY Change From Baseline on Hamilton Anxiety Rating Scale (HAM-A) Scores After 12 Weeks |
-7.10; -5.14 | — |
| SECONDARY Change From Baseline on Clinician Global Impression - Severity (CGI-S) Scale Scores After 12 Weeks |
-1.47; -1.24 | — |
| SECONDARY Change From Baseline on Patient Global Impression - Severity (PGI-S) Scale Scores After 12 Weeks |
-1.25; -0.88 | — |
| SECONDARY Change From Baseline on Insomnia Severity Index (ISI) Scores After 12 Weeks |
-6.16; -3.97 | — |
| SECONDARY Change From Baseline on Sheehan Disability Scale (SDS) Scores After 12 Weeks |
-7.76; -6.38 | — |
| SECONDARY Change From Baseline on PTSD Checklist for DSM-5 (PCL-5) Scores After 12 Weeks |
-21.81; -18.72 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT04951076). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.