Efficacy of BNC210 in Acute, As-needed Treatment of Anxiety in Social Anxiety Disorder - 1
NCT ID: NCT06510504
Last Updated: 2025-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
370 participants
INTERVENTIONAL
2024-08-06
2025-09-19
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
Placebo
Placebo
Placebo
Interventions
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225 mg BNC210
225 mg BNC210
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* A Liebowitz Social Anxiety Scale total score of ≥60.
* Suitable contraception use in line with protocol requirements.
* Ability to swallow tablets.
Exclusion Criteria
* Hamilton Rating Scale for Depression 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.
* 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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AFFIRM-1 Study Site
Encino, California, United States
AFFIRM-1 Study Site
La Jolla, California, United States
AFFIRM-1 Study Site
Los Angeles, California, United States
AFFIRM-1 Study Site
Oceanside, California, United States
AFFIRM-1 Study Site
San Diego, California, United States
AFFIRM-1 Study Site
San Jose, California, United States
AFFIRM-1 Study Site
Sherman Oaks, California, United States
AFFIRM-1 Study Site
Temecula, California, United States
AFFIRM-1 Study Site
Jacksonville, Florida, United States
AFFIRM-1 Study Site
Lauderhill, Florida, United States
AFFIRM-1 Study Site
Miami Lakes, Florida, United States
AFFIRM-1 Study Site
Orlando, Florida, United States
AFFIRM-1 Study Site
Tampa, Florida, United States
AFFIRM-1 Study Site
Decatur, Georgia, United States
AFFIRM-1 Study Site
Boston, Massachusetts, United States
AFFIRM-1 Study Site
Boston, Massachusetts, United States
AFFIRM-1 Study Site
Princeton, New Jersey, United States
AFFIRM-1 Study Site
Brooklyn, New York, United States
AFFIRM-1 Study Site
Charlotte, North Carolina, United States
AFFIRM-1 Study Site
Media, Pennsylvania, United States
AFFIRM-1 Study Site
Austin, Texas, United States
Countries
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Related Links
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Study information and pre-screening portal for potential participants
Other Identifiers
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BNC210.014
Identifier Type: -
Identifier Source: org_study_id
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