A Phase 2 Study of BNC210 for the Acute Treatment of Social Anxiety Disorder
NCT ID: NCT05193409
Last Updated: 2025-03-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
151 participants
INTERVENTIONAL
2022-02-02
2022-10-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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225 mg BNC210
225 mg BNC210
225 mg BNC210
675 mg BNC210
675 mg BNC210
675 mg BNC210
Placebo
Placebo
Placebo
Interventions
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225 mg BNC210
225 mg BNC210
675 mg BNC210
675 mg BNC210
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Liebowitz Social Anxiety Scale (LSAS) total score of ≥70
* Suitable contraception use in line with protocol requirements
* Ability to swallow tablets
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Bionomics Limited
INDUSTRY
Responsible Party
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Locations
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PREVAIL Study Clinical Trial Site
Beverly Hills, California, United States
PREVAIL Study Clinical Trial Site
Encino, California, United States
PREVAIL Study Clinical Trial Site
Glendale, California, United States
PREVAIL Study Clinical Trial Site
New Haven, Connecticut, United States
PREVAIL Study Clinical Trial Site
Lauderhill, Florida, United States
PREVAIL Study Clinical Trial Site
Miami, Florida, United States
PREVAIL Study Clinical Trial Site
Miami Lakes, Florida, United States
PREVAIL Study Clinical Trial Site
Decatur, Georgia, United States
PREVAIL Study Clinical Trial Site
Prairie Village, Kansas, United States
PREVAIL Study Clinical Trial Site
Boston, Massachusetts, United States
PREVAIL Study Clinical Trial Site
Princeton, New Jersey, United States
PREVAIL Study Clinical Trial Site
Brooklyn, New York, United States
PREVAIL Study Clinical Trial Site
Charlotte, North Carolina, United States
PREVAIL Study Clinical Trial Site
Cincinnati, Ohio, United States
PREVAIL Study Clinical Trial Site
Draper, Utah, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BNC210.013
Identifier Type: -
Identifier Source: org_study_id
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