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Completed

NCT Number: NCT05193409

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

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).

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Key information

Conditions

Social Anxiety Disorder Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

PREVAIL Study Clinical Trial Site, Beverly Hills, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

225 mg BNC210

Drug

225 mg BNC210

675 mg BNC210

Drug

675 mg BNC210

Placebo

Drug

Placebo

Primary outcomes

  1. Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a Public Speaking Challenge

    Time frame: Assessed over a single visit: Baseline; and the Performance Phase (0,1,2,3,4,5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.

    The SUDS is a self reported measure of the intensity of distress currently experienced by an individual. The range is 0-100, with a higher score indicating a higher level of anxiety/greater distress.

Secondary outcomes

  1. Change From Baseline to the Average SUDS Score of the 2-minute Anticipation Phase of a Public Speaking Challenge

    Time frame: Assessed over a single visit: Baseline; and the Anticipation Phase (0,1,2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.

    The SUDS is a self reported measure of the intensity of distress currently experienced by an individual. The range is 0-100, with a higher score indicating a higher level of anxiety/greater distress.

  2. Change From Baseline to the End of the 5-minute Performance Phase of Public Speaking Challenge in the State-Trait Anxiety Inventory (State Component; STAI-State) Score

    Time frame: Assessed over a single visit: Baseline; and the Performance Phase (5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.

    The STAI-State is a self reported measure of subjective anxiety at the time of questionnaire completion. The range is 0-80 with a higher total score indicating a higher level of anxiety.

  3. Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the STAI-State Score

    Time frame: Assessed over a single visit: Baseline; and the Anticipation Phase (2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.

    The STAI-State is a self reported measure of subjective anxiety at the time of questionnaire completion. The range is 0-80 with a higher total score indicating a higher level of anxiety.

  4. Change From Baseline to the End of the 5-minute Performance Phase of Public Speaking Challenge in the Self Statements During Public Speaking - Negative Self Statements (SSPS-N) Score

    Time frame: Assessed over a single visit: Baseline; and the Performance Phase (5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.

    The SSPS-N is a self reported measure that assesses cognitions related to public speaking.The range is 0-25 with a higher total score indicating a higher level of negative cognitions.

  5. Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the SSPS-N Score

    Time frame: Assessed over a single visit: Baseline; and the Anticipation Phase (2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.

    The SSPS-N is a self reported measure that assesses cognitions related to public speaking.The range is 0-25 with a higher total score indicating a higher level of negative cognitions.

Sponsors and collaborators

Lead sponsor

Bionomics Limited

Industry

Registry information

Official study 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

Acronym: PREVAIL

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 14, 2022
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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