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

Bionomics

Status and phase

Completed

Phase 2

Conditions

Post-Traumatic Stress Disorder

Treatments

Drug: BNC210

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04951076

BNC210.012

Details and patient eligibility

About

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.

Full 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 2-weekly intervals to complete study 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).

Enrollment

212 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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