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NCT05193409 Clinical Trial

A Phase 2 Study of BNC210 for the Acute Treatment of Social Anxiety Disorder

Social Anxiety Disorder Clinical Trial

— PREVAIL  

Official title:
A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of BNC210 Compared to Placebo for the Acute Treatment of Social Anxiety Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05193409
Other study ID # BNC210.013
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 2, 2022
Est. completion date October 17, 2022

Study information
Verified date November 2022
Source Bionomics Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the effects of an acute dose of BNC210 compared to placebo on reducing anxiety provoked by a speaking challenge and measured using the Subjective Units of Distress Scale (SUDS) in patients with Social Anxiety Disorder (SAD).

Description:

This is a randomized, double-blind, placebo-controlled, 3-arm, parallel-group, multi-center study. Participants will attend a Screening Visit to confirm eligibility and then return to the clinic within 14 days to be randomized into the study. Randomized participants will receive a single dose of their allocated study intervention (225 mg BNC210, 675 mg BNC210 or placebo) and approximately 1 hour later participate in a speaking challenge. After 1 week, a safety follow-up assessment will be conducted by phone/video conference.

Recruitment information / eligibility
Status Completed
Enrollment 151
Est. completion date October 17, 2022
Est. primary completion date October 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Participant has a current diagnosis of Social Anxiety Disorder (SAD) as defined in DSM-5 and confirmed by Structured Clinical Interview for DSM-5 Disorders - Clinical Trials version (SCID-5-CT). - Liebowitz Social Anxiety Scale (LSAS) total score of =70 - Suitable contraception use in line with protocol requirements - Ability to swallow tablets Exclusion Criteria: - History of schizophrenia, bipolar disorder, or psychotic disorders, or has a current clinically predominant diagnosis of any other Axis I disorder, other than SAD - Hamilton Rating Scale for Depression (HAM-D) score of =18 - Moderate or severe alcohol-use disorder, or any other substance-use disorder (any severity) in the past 12 months - Use of psychotropic medications within 30 days of screening. Daily use of benzodiazepines within 90 days of screening. - Previous participation in a study that involved a speaking challenge. - Any clinically significant medical history or findings as determined by the Investigator that could interfere with the objectives of the study or put the participant at risk

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 225 mg BNC210
225 mg BNC210
• 675 mg BNC210
675 mg BNC210
• Placebo
Placebo

Locations
Country Name City State
United States PREVAIL Study Clinical Trial Site Beverly Hills California
United States PREVAIL Study Clinical Trial Site Boston Massachusetts
United States PREVAIL Study Clinical Trial Site Brooklyn New York
United States PREVAIL Study Clinical Trial Site Charlotte North Carolina
United States PREVAIL Study Clinical Trial Site Cincinnati Ohio
United States PREVAIL Study Clinical Trial Site Decatur Georgia
United States PREVAIL Study Clinical Trial Site Draper Utah
United States PREVAIL Study Clinical Trial Site Encino California
United States PREVAIL Study Clinical Trial Site Glendale California
United States PREVAIL Study Clinical Trial Site Lauderhill Florida
United States PREVAIL Study Clinical Trial Site Miami Florida
United States PREVAIL Study Clinical Trial Site Miami Lakes Florida
United States PREVAIL Study Clinical Trial Site New Haven Connecticut
United States PREVAIL Study Clinical Trial Site Prairie Village Kansas
United States PREVAIL Study Clinical Trial Site Princeton New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Bionomics Limited

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Subjective Units of Distress Scale (SUDS) - speaking challenge performance phase 1 Day
Secondary Subjective Units of Distress Scale (SUDS) - speaking challenge anticipation phase 1 Day
Secondary State-Trait Anxiety Inventory (State component; STAI-State) 1 Day
Secondary Self-Statements During Public Speaking Scale (Negative Self-Statements subscale; SSPS-N) 1 Day
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