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

Completed · Phase 2 · Has a placebo group

Conditions studied: Post-Traumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT04951076

Run by

Bionomics Limited

People needed

212

Starts

2021-07-27

Expected to finish

2023-08-14

Last updated by the study team

2025-02-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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