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

Primary Purpose

Social Anxiety Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
225 mg BNC210
675 mg BNC210
Placebo
Sponsored by
Bionomics Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • PREVAIL Study Clinical Trial Site
  • PREVAIL Study Clinical Trial Site
  • PREVAIL Study Clinical Trial Site
  • PREVAIL Study Clinical Trial Site
  • PREVAIL Study Clinical Trial Site
  • PREVAIL Study Clinical Trial Site
  • PREVAIL Study Clinical Trial Site
  • PREVAIL Study Clinical Trial Site
  • PREVAIL Study Clinical Trial Site
  • PREVAIL Study Clinical Trial Site
  • PREVAIL Study Clinical Trial Site
  • PREVAIL Study Clinical Trial Site
  • PREVAIL Study Clinical Trial Site
  • PREVAIL Study Clinical Trial Site
  • PREVAIL Study Clinical Trial Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

225 mg BNC210

675 mg BNC210

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Subjective Units of Distress Scale (SUDS) - speaking challenge performance phase

Secondary Outcome Measures

Subjective Units of Distress Scale (SUDS) - speaking challenge anticipation phase
State-Trait Anxiety Inventory (State component; STAI-State)
Self-Statements During Public Speaking Scale (Negative Self-Statements subscale; SSPS-N)

Full Information

First Posted
January 3, 2022
Last Updated
November 28, 2022
Sponsor
Bionomics Limited
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1. Study Identification

Unique Protocol Identification Number
NCT05193409
Brief Title
A Phase 2 Study of BNC210 for the Acute Treatment of Social Anxiety Disorder
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
October 10, 2022 (Actual)
Study Completion Date
October 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bionomics Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
225 mg BNC210
Arm Type
Experimental
Arm Title
675 mg BNC210
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
225 mg BNC210
Intervention Description
225 mg BNC210
Intervention Type
Drug
Intervention Name(s)
675 mg BNC210
Intervention Description
675 mg BNC210
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Subjective Units of Distress Scale (SUDS) - speaking challenge performance phase
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
Subjective Units of Distress Scale (SUDS) - speaking challenge anticipation phase
Time Frame
1 Day
Title
State-Trait Anxiety Inventory (State component; STAI-State)
Time Frame
1 Day
Title
Self-Statements During Public Speaking Scale (Negative Self-Statements subscale; SSPS-N)
Time Frame
1 Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
PREVAIL Study Clinical Trial Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
PREVAIL Study Clinical Trial Site
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
PREVAIL Study Clinical Trial Site
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
PREVAIL Study Clinical Trial Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
33122
Country
United States
Facility Name
PREVAIL Study Clinical Trial Site
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
PREVAIL Study Clinical Trial Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
PREVAIL Study Clinical Trial Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
PREVAIL Study Clinical Trial Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
PREVAIL Study Clinical Trial Site
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States
Facility Name
PREVAIL Study Clinical Trial Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
PREVAIL Study Clinical Trial Site
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
PREVAIL Study Clinical Trial Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Facility Name
PREVAIL Study Clinical Trial Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
PREVAIL Study Clinical Trial Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
PREVAIL Study Clinical Trial Site
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States

12. IPD Sharing Statement

Links:
URL
https://prevailstudy.com/
Description
further study information for potential participants

Learn more about this trial

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

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