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BNC210 for Social Anxiety Disorder (AFFIRM-1 Trial)

Phase 3
Recruiting
Research Sponsored by Bionomics Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights
Pivotal Trial

Summary

This trial aims to see if a one-time dose of BNC210 can help reduce anxiety in adults with social anxiety disorder during a behavioral assessment. They will measure anxiety levels using a scale called the Subject

Who is the study for?
This trial is for adults with social anxiety disorder who score at least 60 on the Liebowitz Social Anxiety Scale, indicating significant symptoms. Participants must be able to swallow tablets and use suitable contraception as per protocol.
What is being tested?
The study tests if a single dose of BNC210 can reduce anxiety levels more effectively than a placebo in people with social anxiety disorder. Anxiety reduction is measured during a specific task using the Subjective Units of Distress Scale.
What are the potential side effects?
Potential side effects are not detailed here, but generally could include reactions typical for anti-anxiety medications such as drowsiness, dizziness, nausea, or headache.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Subjective Units of Distress Scale (SUDS)
Secondary study objectives
Clinical Global Impressions-Severity (CGI-S)
Patient Global Impressions-Improvement (PGI-I)
State-Trait Anxiety Inventory (State Component; STAI-State)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 225 mg BNC210Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
225 mg BNC210
2022
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

Bionomics LimitedLead Sponsor
7 Previous Clinical Trials
770 Total Patients Enrolled
~211 spots leftby Aug 2025
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