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

Post-Traumatic Stress Disorder Clinical Trial

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 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04951076
Study type Interventional
Source Bionomics Limited
Contact
Status Completed
Phase Phase 2
Start date July 27, 2021
Completion date August 14, 2023
View Details
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