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

Post-Traumatic Stress Disorder Clinical Trial

— ATTUNE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04951076
• Other study ID #: BNC210.012
• Status: Completed
• Phase: Phase 2
• Start date: July 27, 2021
• Est. completion date: August 14, 2023

Study information

• Verified date: August 2023
• Source: Bionomics Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: August 14, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• BNC210
BNC210 900 mg twice daily (b.i.d.) for 12 weeks
• Placebo
Placebo twice daily (b.i.d.) for 12 weeks

Locations

Country	Name	City	State
United Kingdom	ATTUNE Study Clinical Trial Site	Barnsley
United Kingdom	ATTUNE Study Clinical Trial Site	Blackpool
United Kingdom	ATTUNE Study Clinical Trial Site	Cannock
United Kingdom	ATTUNE Study Clinical Trial Site	Leeds
United Kingdom	ATTUNE Study Clinical Trial Site	Liverpool
United Kingdom	ATTUNE Study Clinical Trial Site	Manchester
United Kingdom	ATTUNE Study Clinical Trial Site	Stockton-on-Tees
United States	ATTUNE Study Clinical Trial Site	Austin	Texas
United States	ATTUNE Study Clinical Trial Site	Bellflower	California
United States	ATTUNE Study Clinical Trial Site	Berlin	New Jersey
United States	ATTUNE Study Clinical Trial Site	Beverly Hills	California
United States	ATTUNE Study Clinical Trial Site	Cedarhurst	New York
United States	ATTUNE Study Clinical Trial Site	Cherry Hill	New Jersey
United States	ATTUNE Study Clinical Trial Site	Colton	California
United States	ATTUNE Study Clinical Trial Site	Dallas	Texas
United States	ATTUNE Study Clinical Trial Site	Draper	Utah
United States	ATTTUNE Study Clinical Trial Site	Jacksonville	Florida
United States	ATTUNE Study Clinical Trial Site	Las Vegas	Nevada
United States	ATTUNE Study Clinical Trial Site	Lauderhill	Florida
United States	ATTUNE Study Clinical Trial Site	Memphis	Tennessee
United States	ATTUNE Study Clinical Trial Site	Miami Lakes	Florida
United States	ATTUNE Study Clinical Trial Site	New Bedford	Massachusetts
United States	ATTUNE Study Clinical Trial Site	North Canton	Ohio
United States	ATTUNE Study Clinical Trial Site	Oceanside	California
United States	ATTUNE Study Clinical Trial Site	Oklahoma City	Oklahoma
United States	ATTUNE Study Clinical Trial Site	Orange	California
United States	ATTUNE Study Clinical Trial Site	Orlando	Florida
United States	ATTUNE Study Clinical Trial Site	Overland Park	Kansas
United States	ATTUNE Study Clinical Trial Site	Prairie Village	Kansas
United States	ATTUNE Study Clinical Trial Site	Staten Island	New York
United States	ATTUNE Study Clinical Trial Site	Temecula	California
United States	ATTUNE Study Clinical Trial Site	West Chester	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bionomics Limited

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale for DSM-5 (CAPS-5)	Change from Baseline on Investigator-rated symptoms of PTSD (total symptom severity scores)	12 weeks
Secondary	Clinician Administered PTSD Scale for DSM-5 (CAPS-5)	Change from Baseline on Investigator-rated symptom clusters of PTSD (symptom cluster scores)	12 Weeks
Secondary	Clinician Administered PTSD Scale for DSM-5 (CAPS-5)	Response rate and remission rate using Investigator-rated symptoms of PTSD (total symptom severity scores)	12 weeks
Secondary	PTSD Checklist for DSM-5 (PCL-5)	Change from Baseline on patient-reported symptoms of PTSD	12 weeks
Secondary	Montgomery Asberg Depression Rating Scale (MADRS)	Change from Baseline on Investigator-rated symptoms of depression	12 Weeks
Secondary	Hamilton Anxiety Rating Scale (HAM-A)	Change from Baseline on Investigator-rated symptoms of anxiety	12 Weeks
Secondary	Clinician Global Impression (CGI)	Change from Baseline on Investigator-rated global functioning	12 weeks
Secondary	Patient Global Impression (PGI)	Change from Baseline on patient-reported global functioning	12 weeks
Secondary	Insomnia Severity Index (ISI)	Change from Baseline on patient-reported sleep quality	12 weeks
Secondary	Sheehan Disability Scale (SDS)	Change from Baseline on patient-reported social functioning	12 weeks