NCT04951076

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 212 (actual)
• Sponsor: Bionomics Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	BNC210	BNC210 900 mg twice daily (b.i.d.) for 12 weeks
DRUG	Placebo	Placebo twice daily (b.i.d.) for 12 weeks

Timeline

• Start date: 2021-07-27
• Primary completion: 2023-07-25
• Completion: 2023-08-14
• First posted: 2021-07-06
• Last updated: 2025-02-06
• Results posted: 2025-02-06

Locations

32 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study