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

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bionomics Limited

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