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

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ClinicalTrials.gov Identifier: NCT05193409
Recruitment Status : Completed
First Posted : January 14, 2022
Last Update Posted : November 30, 2022
Sponsor:
Information provided by (Responsible Party):
Bionomics Limited

Study Description
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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).

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Drug: 225 mg BNC210 Drug: 675 mg BNC210 Drug: Placebo Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 2, 2022
Actual Primary Completion Date : October 10, 2022
Actual Study Completion Date : October 17, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Experimental: 225 mg BNC210 Drug: 225 mg BNC210
225 mg BNC210
Experimental: 675 mg BNC210 Drug: 675 mg BNC210
675 mg BNC210
Placebo Comparator: Placebo Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Subjective Units of Distress Scale (SUDS) - speaking challenge performance phase [ Time Frame: 1 Day ]

Secondary Outcome Measures :
  1. Subjective Units of Distress Scale (SUDS) - speaking challenge anticipation phase [ Time Frame: 1 Day ]
  2. State-Trait Anxiety Inventory (State component; STAI-State) [ Time Frame: 1 Day ]
  3. Self-Statements During Public Speaking Scale (Negative Self-Statements subscale; SSPS-N) [ Time Frame: 1 Day ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05193409


Locations
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United States, California
PREVAIL Study Clinical Trial Site
Beverly Hills, California, United States, 90210
PREVAIL Study Clinical Trial Site
Encino, California, United States, 91316
PREVAIL Study Clinical Trial Site
Glendale, California, United States, 91204
United States, Connecticut
PREVAIL Study Clinical Trial Site
New Haven, Connecticut, United States, 33122
United States, Florida
PREVAIL Study Clinical Trial Site
Lauderhill, Florida, United States, 33319
PREVAIL Study Clinical Trial Site
Miami Lakes, Florida, United States, 33016
PREVAIL Study Clinical Trial Site
Miami, Florida, United States, 33122
United States, Georgia
PREVAIL Study Clinical Trial Site
Decatur, Georgia, United States, 30030
United States, Kansas
PREVAIL Study Clinical Trial Site
Prairie Village, Kansas, United States, 66208
United States, Massachusetts
PREVAIL Study Clinical Trial Site
Boston, Massachusetts, United States, 02114
United States, New Jersey
PREVAIL Study Clinical Trial Site
Princeton, New Jersey, United States, 08540
United States, New York
PREVAIL Study Clinical Trial Site
Brooklyn, New York, United States, 11229
United States, North Carolina
PREVAIL Study Clinical Trial Site
Charlotte, North Carolina, United States, 28211
United States, Ohio
PREVAIL Study Clinical Trial Site
Cincinnati, Ohio, United States, 45212
United States, Utah
PREVAIL Study Clinical Trial Site
Draper, Utah, United States, 84020
Sponsors and Collaborators
Bionomics Limited
More Information
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Additional Information:

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Responsible Party: Bionomics Limited
ClinicalTrials.gov Identifier: NCT05193409    
Other Study ID Numbers: BNC210.013
First Posted: January 14, 2022    Key Record Dates
Last Update Posted: November 30, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Phobia, Social
Mental Disorders
Phobic Disorders