NCT02933606

Phase II Study of BNC210 in PTSD

A Randomized, Double-blind, Placebo-controlled Phase II Study of BNC210 in Adults With Post-Traumatic Stress Disorder (PTSD).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: Bionomics Limited · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled study, evaluating the effects of BNC210 versus placebo on the symptoms of Post-Traumatic Stress Disorder, as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). The secondary objectives of the study are to evaluate the effects of BNC210 on anxiety, depression, global functioning and patient reported outcomes in patients with PTSD. Safety and tolerability of BNC210 will also be assessed. Study participants will receive 12 weeks of blinded treatment followed by a 3 week follow-up period.

Conditions

• Post-Traumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	BNC210
DRUG	Placebo

Timeline

• Start date: 2016-06-30
• Primary completion: 2018-07-05
• Completion: 2018-07-25
• First posted: 2016-10-14
• Last updated: 2023-02-27
• Results posted: 2023-02-27

Locations

25 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study