Trial · NCT05193409
A Phase 2 Study of BNC210 for the Acute Treatment of Social Anxiety Disorder
NCT05193409, Phase 2, Completed, Bionomics Limited; results first posted 2025-03-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 2 Study of BNC210 for the Acute Treatment of Social Anxiety Disorder. Trials, record NCT05193409. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05193409
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Study of BNC210 for the Acute Treatment of Social Anxiety Disorder
- NCT number
- NCT05193409
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 151 participants, actual
- Lead sponsor
- Bionomics Limited
- Conditions
- Social Anxiety Disorder
- Interventions
- 225 mg BNC210, 675 mg BNC210, Placebo
- First posted
- 2022-01-14
- Last updated
- 2025-03-18
- Results first posted
- 2025-03-18
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 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 | Change From Baseline to the Average SUDS Score of the 2-minute Anticipation Phase of a Public Speaking Challenge | 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. |
| 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 | 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. |
| Secondary | Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the STAI-State Score | 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. |
| 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 | 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. |
| Secondary | Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the SSPS-N Score | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | 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. | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline to the Average SUDS Score of the 2-minute Anticipation Phase of a Public Speaking Challenge | Assessed over a single visit: Baseline; and the Anticipation Phase (0,1,2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose. | score on a scale | LEAST_SQUARES_MEAN | |
| 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 | Assessed over a single visit: Baseline; and the Performance Phase (5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose. | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the STAI-State Score | Assessed over a single visit: Baseline; and the Anticipation Phase (2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose. | score on a scale | LEAST_SQUARES_MEAN | |
| 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 | Assessed over a single visit: Baseline; and the Performance Phase (5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose. | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the SSPS-N Score | Assessed over a single visit: Baseline; and the Anticipation Phase (2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose. | score on a scale | LEAST_SQUARES_MEAN | |
| 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. | 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. | 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. | score on a scale * minutes | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a Public Speaking Challenge | 225 mg BNC210 | 22.42 | 95% Confidence Interval 15.78 to 29.06 | score on a scale | |
| Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a Public Speaking Challenge | 675 mg BNC210 | 24.26 | 95% Confidence Interval 17.70 to 30.82 | score on a scale | |
| Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a Public Speaking Challenge | Placebo | 29.03 | 95% Confidence Interval 22.44 to 35.62 | score on a scale | |
| Change From Baseline to the Average SUDS Score of the 2-minute Anticipation Phase of a Public Speaking Challenge | 225 mg BNC210 | 15.18 | 95% Confidence Interval 9.57 to 20.79 | score on a scale | |
| Change From Baseline to the Average SUDS Score of the 2-minute Anticipation Phase of a Public Speaking Challenge | 675 mg BNC210 | 12.86 | 95% Confidence Interval 7.31 to 18.41 | score on a scale | |
| Change From Baseline to the Average SUDS Score of the 2-minute Anticipation Phase of a Public Speaking Challenge | Placebo | 18.95 | 95% Confidence Interval 13.37 to 24.52 | score on a scale | |
| 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 | 225 mg BNC210 | 3.83 | 95% Confidence Interval 0.17 to 7.50 | score on a scale | |
| 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 | 675 mg BNC210 | 3.04 | 95% Confidence Interval -0.06 to 6.69 | score on a scale | |
| 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 | Placebo | 4.71 | 95% Confidence Interval 1.04 to 8.39 | score on a scale | |
| Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the STAI-State Score | 225 mg BNC210 | 5.77 | 95% Confidence Interval 2.77 to 8.78 | score on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 225 mg BNC210 | 50 | |
| Overall Study | STARTED | 675 mg BNC210 | 51 | |
| Overall Study | STARTED | Placebo | 50 | |
| Overall Study | COMPLETED | 225 mg BNC210 | 50 | |
| Overall Study | COMPLETED | 675 mg BNC210 | 51 | |
| Overall Study | COMPLETED | Placebo | 50 | |
| Overall Study | NOT COMPLETED | 225 mg BNC210 | 0 | |
| Overall Study | NOT COMPLETED | 675 mg BNC210 | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events9
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Somnolence | Nervous system disorders | 225 mg BNC210 | 2 | 50 | |
| other | Somnolence | Nervous system disorders | 675 mg BNC210 | 6 | 51 | |
| other | Somnolence | Nervous system disorders | Placebo | 2 | 50 | |
| other | Headache | Nervous system disorders | 225 mg BNC210 | 3 | 50 | |
| other | Headache | Nervous system disorders | 675 mg BNC210 | 2 | 51 | |
| other | Headache | Nervous system disorders | Placebo | 1 | 50 | |
| other | Dizziness | Nervous system disorders | 225 mg BNC210 | 1 | 50 | |
| other | Dizziness | Nervous system disorders | 675 mg BNC210 | 3 | 51 | |
| other | Dizziness | Nervous system disorders | Placebo | 0 | 50 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 225 mg BNC210 | 0 | 50 |
| Total, all-cause mortality | 675 mg BNC210 | 0 | 51 |
| Total, all-cause mortality | Placebo | 0 | 50 |
| Total, other adverse events | 225 mg BNC210 | 6 | 50 |
| Total, other adverse events | 675 mg BNC210 | 10 | 51 |
| Total, other adverse events | Placebo | 3 | 50 |
| Total, serious adverse events | 225 mg BNC210 | 0 | 50 |
| Total, serious adverse events | 675 mg BNC210 | 0 | 51 |
| Total, serious adverse events | Placebo | 0 | 50 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39954310 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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