Clinical trial NCT05193409: A Phase 2 Study of BNC210 for the Acute Treatment of Social Anxiety Disorder
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Social Anxiety Disorder
Lead sponsor: Bionomics Limited
Sponsor class: INDUSTRY
First posted: 2022-01-14
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline to the Average Subjective Units of Distress Scale (SUDS) Score of the 5-minute Performance Phase of a Public Speaking Challenge
timeFrame: 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.
Secondary outcomes:
measure: Change From Baseline to the Average SUDS Score of the 2-minute Anticipation Phase of a Public Speaking Challenge
timeFrame: Assessed over a single visit: Baseline; and the Anticipation Phase (0,1,2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.
measure: 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
timeFrame: Assessed over a single visit: Baseline; and the Performance Phase (5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.
measure: Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the STAI-State Score
timeFrame: Assessed over a single visit: Baseline; and the Anticipation Phase (2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.
measure: 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
timeFrame: Assessed over a single visit: Baseline; and the Performance Phase (5 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.
measure: Change From Baseline to the End of the 2-minute Anticipation Phase of Public Speaking Challenge in the SSPS-N Score
timeFrame: Assessed over a single visit: Baseline; and the Anticipation Phase (2 minutes) of the Public Speaking Challenge, conducted 1 hour post-dose.
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: PREVAIL Study Clinical Trial Site
state: California
city: Encino
country: United States
facility: PREVAIL Study Clinical Trial Site
state: California
city: Glendale
country: United States
facility: PREVAIL Study Clinical Trial Site
state: California
city: New Haven
country: United States
facility: PREVAIL Study Clinical Trial Site
state: Connecticut
city: Lauderhill
country: United States
facility: PREVAIL Study Clinical Trial Site
state: Florida
city: Miami Lakes
country: United States
facility: PREVAIL Study Clinical Trial Site
state: Florida
city: Miami
country: United States
facility: PREVAIL Study Clinical Trial Site
state: Florida
city: Decatur
country: United States
facility: PREVAIL Study Clinical Trial Site
state: Georgia
city: Prairie Village
country: United States
facility: PREVAIL Study Clinical Trial Site
state: Kansas
city: Boston
country: United States
facility: PREVAIL Study Clinical Trial Site
state: Massachusetts
city: Princeton
country: United States
facility: PREVAIL Study Clinical Trial Site
state: New Jersey
city: Brooklyn
country: United States
facility: PREVAIL Study Clinical Trial Site
state: New York
city: Charlotte
country: United States
facility: PREVAIL Study Clinical Trial Site
state: North Carolina
city: Cincinnati
country: United States
facility: PREVAIL Study Clinical Trial Site
state: Ohio
city: Draper
country: United States
facility: PREVAIL Study Clinical Trial Site
state: Utah
Study officials:
References:
citation: 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.