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

NCT ID: NCT04951076

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-27
• Study Completion Date: 2023-08-14

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).

Conditions

Post-Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BNC210

Group Type: EXPERIMENTAL

BNC210

Intervention Type: DRUG

BNC210 900 mg twice daily (b.i.d.) for 12 weeks

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo twice daily (b.i.d.) for 12 weeks

Interventions

BNC210

BNC210 900 mg twice daily (b.i.d.) for 12 weeks

Intervention Type: DRUG

Placebo

Placebo twice daily (b.i.d.) for 12 weeks

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bionomics Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ATTUNE Study Clinical Trial Site

Bellflower, California, United States

ATTUNE Study Clinical Trial Site

Beverly Hills, California, United States

ATTUNE Study Clinical Trial Site

Colton, California, United States

ATTUNE Study Clinical Trial Site

Oceanside, California, United States

ATTUNE Study Clinical Trial Site

Orange, California, United States

ATTUNE Study Clinical Trial Site

Temecula, California, United States

ATTTUNE Study Clinical Trial Site

Jacksonville, Florida, United States

ATTUNE Study Clinical Trial Site

Lauderhill, Florida, United States

ATTUNE Study Clinical Trial Site

Miami Lakes, Florida, 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

New Bedford, Massachusetts, United States

ATTUNE Study Clinical Trial Site

Las Vegas, Nevada, United States

ATTUNE Study Clinical Trial Site

Berlin, New Jersey, United States

ATTUNE Study Clinical Trial Site

Cherry Hill, New Jersey, United States

ATTUNE Study Clinical Trial Site

Cedarhurst, New York, United States

ATTUNE Study Clinical Trial Site

Staten Island, New York, United States

ATTUNE Study Clinical Trial Site

North Canton, Ohio, United States

ATTUNE Study Clinical Trial Site

Oklahoma City, Oklahoma, United States

ATTUNE Study Clinical Trial Site

West Chester, Pennsylvania, United States

ATTUNE Study Clinical Trial Site

Memphis, Tennessee, United States

ATTUNE Study Clinical Trial Site

Austin, Texas, United States

ATTUNE Study Clinical Trial Site

Dallas, Texas, United States

ATTUNE Study Clinical Trial Site

Draper, Utah, United States

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 Kingdom

Countries

United States; United Kingdom

References

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.

Reference Type: RESULT

PMID: 39647171 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BNC210.012

Identifier Type: -

Identifier Source: org_study_id