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COMPLETED
NCT06510504
PHASE3

Efficacy of BNC210 in Acute, As-needed Treatment of Anxiety in Social Anxiety Disorder - 1

Sponsor: Bionomics Limited

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the effect of a single, acute dose of BNC210 compared to placebo on reducing the severity of anxiety provoked by a behavioral assessment task and measured using the Subjective Units of Distress Scale (SUDS) in adult patients with social anxiety disorder.

Official title: A Phase 3, Randomized, Double-blind, 2-arm, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of BNC210 for the Acute, As-needed Treatment of Anxiety in Adults With Social Anxiety Disorder

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

370

Start Date

2024-08-06

Completion Date

2025-09-19

Last Updated

2026-05-19

Healthy Volunteers

No

Interventions

DRUG

225 mg BNC210

225 mg BNC210

DRUG

Placebo

Placebo

Locations (21)

AFFIRM-1 Study Site

Encino, California, United States

AFFIRM-1 Study Site

La Jolla, California, United States

AFFIRM-1 Study Site

Los Angeles, California, United States

AFFIRM-1 Study Site

Oceanside, California, United States

AFFIRM-1 Study Site

San Diego, California, United States

AFFIRM-1 Study Site

San Jose, California, United States

AFFIRM-1 Study Site

Sherman Oaks, California, United States

AFFIRM-1 Study Site

Temecula, California, United States

AFFIRM-1 Study Site

Jacksonville, Florida, United States

AFFIRM-1 Study Site

Lauderhill, Florida, United States

AFFIRM-1 Study Site

Miami Lakes, Florida, United States

AFFIRM-1 Study Site

Orlando, Florida, United States

AFFIRM-1 Study Site

Tampa, Florida, United States

AFFIRM-1 Study Site

Decatur, Georgia, United States

AFFIRM-1 Study Site

Boston, Massachusetts, United States

AFFIRM-1 Study Site

Boston, Massachusetts, United States

AFFIRM-1 Study Site

Princeton, New Jersey, United States

AFFIRM-1 Study Site

Brooklyn, New York, United States

AFFIRM-1 Study Site

Charlotte, North Carolina, United States

AFFIRM-1 Study Site

Media, Pennsylvania, United States

AFFIRM-1 Study Site

Austin, Texas, United States