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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 225 mg BNC210 | Experimental |
| |
| 675 mg BNC210 | Experimental |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 225 mg BNC210 | Drug | 225 mg BNC210 |
| |
| 675 mg BNC210 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a Public Speaking Challenge | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to the Average SUDS Score of the 2-minute Anticipation Phase of a Public Speaking Challenge | 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. | Assessed over a single visit: Baseline; and the Anticipation Phase (0,1,2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PREVAIL Study Clinical Trial Site | Beverly Hills | California | 90210 | United States | ||
| PREVAIL Study Clinical Trial Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39954310 | Result | Papapetropoulos S, Doolin E, Odontiadis M, Paul D, Jaros M, Rolan P, Taylor C, Stein MB. A phase 2, placebo-controlled study to evaluate the efficacy and safety of BNC210, an alpha-7 nicotinic receptor negative allosteric modulator, for acute, as-needed treatment of social anxiety disorder (SAD) - The PREVAIL study. Psychiatry Res. 2025 Apr;346:116387. doi: 10.1016/j.psychres.2025.116387. Epub 2025 Feb 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 225 mg BNC210 | 225 mg BNC210 tablet single dose |
| FG001 | 675 mg BNC210 | 675 mg BNC210 tablet single dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 17, 2021 | Feb 16, 2025 |
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| Drug |
675 mg BNC210 |
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| Placebo | Drug | Placebo |
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| 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 | 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. | Assessed over a single visit: Baseline; and the Performance Phase (5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose. |
| Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the STAI-State Score | 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. | Assessed over a single visit: Baseline; and the Anticipation Phase (2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose. |
| 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 | 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. | Assessed over a single visit: Baseline; and the Performance Phase (5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose. |
| Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the SSPS-N Score | 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. | Assessed over a single visit: Baseline; and the Anticipation Phase (2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose. |
| Encino |
| California |
| 91316 |
| United States |
| PREVAIL Study Clinical Trial Site | Glendale | California | 91204 | United States |
| PREVAIL Study Clinical Trial Site | New Haven | Connecticut | 33122 | United States |
| PREVAIL Study Clinical Trial Site | Lauderhill | Florida | 33319 | United States |
| PREVAIL Study Clinical Trial Site | Miami | Florida | 33122 | United States |
| PREVAIL Study Clinical Trial Site | Miami Lakes | Florida | 33016 | United States |
| PREVAIL Study Clinical Trial Site | Decatur | Georgia | 30030 | United States |
| PREVAIL Study Clinical Trial Site | Prairie Village | Kansas | 66208 | United States |
| PREVAIL Study Clinical Trial Site | Boston | Massachusetts | 02114 | United States |
| PREVAIL Study Clinical Trial Site | Princeton | New Jersey | 08540 | United States |
| PREVAIL Study Clinical Trial Site | Brooklyn | New York | 11229 | United States |
| PREVAIL Study Clinical Trial Site | Charlotte | North Carolina | 28211 | United States |
| PREVAIL Study Clinical Trial Site | Cincinnati | Ohio | 45212 | United States |
| PREVAIL Study Clinical Trial Site | Draper | Utah | 84020 | United States |
| FG002 |
| Placebo |
Placebo tablet single dose |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 225 mg BNC210 | 225 mg BNC210 tablet single dose |
| BG001 | 675 mg BNC210 | 675 mg BNC210 tablet single dose |
| BG002 | Placebo | Placebo tablet single dose |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Liebowitz Social Anxiety Scale (LSAS) | The Liebowitz Social Anxiety Scale (LSAS) is a clinician administered rating scale used for the quantification of symptomatic distress and impairment caused by social anxiety disorder (SAD). The scale includes 24 items divided into two subscales (fear or anxiety, and avoidance) that evaluate social, interactional and performance situations. Scores on each of the items are added to give a global score ranging from 0-144, with higher scores indicating greater severity of SAD symptoms. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a Public Speaking Challenge | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 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. |
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| Secondary | Change From Baseline to the Average SUDS Score of the 2-minute Anticipation Phase of a Public Speaking Challenge | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Assessed over a single visit: Baseline; and the Anticipation Phase (0,1,2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose. |
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| Secondary | 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 | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Assessed over a single visit: Baseline; and the Performance Phase (5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose. |
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| Secondary | Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the STAI-State Score | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Assessed over a single visit: Baseline; and the Anticipation Phase (2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose. |
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| Secondary | 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 | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Assessed over a single visit: Baseline; and the Performance Phase (5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose. |
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| Secondary | Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the SSPS-N Score | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Assessed over a single visit: Baseline; and the Anticipation Phase (2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose. |
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| Post-Hoc | Change From Baseline in the Area Under the Curve (AUC) of the Combined SUDS Scores of the Anticipation and Performance Phases of a Public Speaking Challenge. | 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. | To increase the sample size for the post-hoc analysis, data were combined for the two active BNC210 treatment groups versus placebo. Only participants who completed the public speaking challenge were included. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale * minutes | 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. |
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1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 225 mg BNC210 | 225 mg BNC210 single dose | 0 | 50 | 0 | 50 | 6 | 50 |
| EG001 | 675 mg BNC210 | 675 mg BNC210 single dose | 0 | 51 | 0 | 51 | 10 | 51 |
| EG002 | Placebo | Placebo single dose | 0 | 50 | 0 | 50 | 3 | 50 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| SVP Clinical Development | Bionomics Limited | +61 8 8150 7400 | BNC210clinicalstudies@bionomics.com.au |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 18, 2022 | Feb 16, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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