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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05193409
Recruitment Status : Recruiting
First Posted : January 14, 2022
Last Update Posted : April 29, 2022
Sponsor:
Information provided by (Responsible Party):
Bionomics Limited

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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




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 ]


Information from the National Library of Medicine

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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

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


Contacts
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Contact: BNC210 Clinical Studies Bionomics Limited +61 8 8150 7400 bnc210clinicalstudies@bionomics.com.au

Locations
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United States, California
PREVAIL Study Clinical Trial Site Recruiting
Beverly Hills, California, United States, 90210
PREVAIL Study Clinical Trial Site Recruiting
Encino, California, United States, 91316
PREVAIL Study Clinical Trial Site Recruiting
Glendale, California, United States, 91204
United States, Florida
PREVAIL Study Clinical Trial Site Recruiting
Lauderhill, Florida, United States, 33319
PREVAIL Study Clinical Trial Site Recruiting
Miami Lakes, Florida, United States, 33016
United States, Georgia
PREVAIL Study Clinical Trial Site Recruiting
Decatur, Georgia, United States, 30030
United States, Kansas
PREVAIL Study Clinical Trial Site Recruiting
Prairie Village, Kansas, United States, 66208
United States, Nebraska
PREVAIL Study Clinical Trial Site Recruiting
Lincoln, Nebraska, United States, 68526
United States, New York
PREVAIL Study Clinical Trial Site Recruiting
Brooklyn, New York, United States, 11229
United States, Utah
PREVAIL Study Clinical Trial Site Recruiting
Draper, Utah, United States, 84020
Sponsors and Collaborators
Bionomics Limited
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: April 29, 2022
Last Verified: April 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