A Phase 2 Study of BNC210 for the Acute Treatment of Social Anxiety Disorder (PREVAIL)
- Study HIC#:2000032550
- Last Updated:07/05/2022
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).
- Age18 years - 65 years
- Start Date06/27/2022
- End Date10/31/2022
Trial Purpose and 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.
- 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
- 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