Clinical trial NCT04951076: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-Traumatic Stress Disorder
Lead sponsor: Bionomics Limited
Sponsor class: INDUSTRY
First posted: 2021-07-06
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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).

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

Primary outcomes:
measure: 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
timeFrame: Baseline, 4 weeks, 8 weeks,12 weeks
Secondary outcomes:
measure: Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion B Symptom Cluster Scores After 12 Weeks
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion C Symptom Cluster Scores After 12 Weeks
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion D Symptom Cluster Scores After 12 Weeks
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion E Symptom Cluster Scores After 12 Weeks
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change From Baseline on Montgomery Asberg Depression Rating Scale (MADRS) Scores After 12 Weeks
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change From Baseline on Hamilton Anxiety Rating Scale (HAM-A) Scores After 12 Weeks
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change From Baseline on Clinician Global Impression - Severity (CGI-S) Scale Scores After 12 Weeks
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change From Baseline on Patient Global Impression - Severity (PGI-S) Scale Scores After 12 Weeks
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change From Baseline on Insomnia Severity Index (ISI) Scores After 12 Weeks
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change From Baseline on Sheehan Disability Scale (SDS) Scores After 12 Weeks
timeFrame: Baseline, 4 weeks, 8 weeks,12 weeks
measure: Change From Baseline on PTSD Checklist for DSM-5 (PCL-5) Scores After 12 Weeks
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Bellflower
country: United States
facility: ATTUNE Study Clinical Trial Site
state: California
city: Beverly Hills
country: United States
facility: ATTUNE Study Clinical Trial Site
state: California
city: Colton
country: United States
facility: ATTUNE Study Clinical Trial Site
state: California
city: Oceanside
country: United States
facility: ATTUNE Study Clinical Trial Site
state: California
city: Orange
country: United States
facility: ATTUNE Study Clinical Trial Site
state: California
city: Temecula
country: United States
facility: ATTUNE Study Clinical Trial Site
state: California
city: Jacksonville
country: United States
facility: ATTTUNE Study Clinical Trial Site
state: Florida
city: Lauderhill
country: United States
facility: ATTUNE Study Clinical Trial Site
state: Florida
city: Miami Lakes
country: United States
facility: ATTUNE Study Clinical Trial Site
state: Florida
city: Orlando
country: United States
facility: ATTUNE Study Clinical Trial Site
state: Florida
city: Overland Park
country: United States
facility: ATTUNE Study Clinical Trial Site
state: Kansas
city: Prairie Village
country: United States
facility: ATTUNE Study Clinical Trial Site
state: Kansas
city: New Bedford
country: United States
facility: ATTUNE Study Clinical Trial Site
state: Massachusetts
city: Las Vegas
country: United States
facility: ATTUNE Study Clinical Trial Site
state: Nevada
city: Berlin
country: United States
facility: ATTUNE Study Clinical Trial Site
state: New Jersey
city: Cherry Hill
country: United States
facility: ATTUNE Study Clinical Trial Site
state: New Jersey
city: Cedarhurst
country: United States
facility: ATTUNE Study Clinical Trial Site
state: New York
city: Staten Island
country: United States
facility: ATTUNE Study Clinical Trial Site
state: New York
city: North Canton
country: United States
facility: ATTUNE Study Clinical Trial Site
state: Ohio
city: Oklahoma City
country: United States
facility: ATTUNE Study Clinical Trial Site
state: Oklahoma
city: West Chester
country: United States
facility: ATTUNE Study Clinical Trial Site
state: Pennsylvania
city: Memphis
country: United States
facility: ATTUNE Study Clinical Trial Site
state: Tennessee
city: Austin
country: United States
facility: ATTUNE Study Clinical Trial Site
state: Texas
city: Dallas
country: United States
facility: ATTUNE Study Clinical Trial Site
state: Texas
city: Draper
country: United States
facility: ATTUNE Study Clinical Trial Site
state: Utah
city: Barnsley
country: United Kingdom
facility: ATTUNE Study Clinical Trial Site
city: Blackpool
country: United Kingdom
facility: ATTUNE Study Clinical Trial Site
city: Cannock
country: United Kingdom
facility: ATTUNE Study Clinical Trial Site
city: Leeds
country: United Kingdom
facility: ATTUNE Study Clinical Trial Site
city: Liverpool
country: United Kingdom
facility: ATTUNE Study Clinical Trial Site
city: Manchester
country: United Kingdom
facility: ATTUNE Study Clinical Trial Site
city: Stockton-on-Tees
country: United Kingdom
facility: ATTUNE Study Clinical Trial Site
Study officials:
References:
citation: Papapetropoulos S, Doolin E, O'Connor S, Paul D, Odontiadis M, Jaros M, Rolan P, Stein MB. BNC210, an alpha7 Nicotinic Receptor Modulator, in Post-Traumatic Stress Disorder. NEJM Evid. 2025 Jan;4(1):EVIDoa2400380. doi: 10.1056/EVIDoa2400380. Epub 2024 Dec 8.