Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510504
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Efficacy of BNC210 in Acute As-needed Treatment of Anxiety in Social Anxiety Disorder - 1
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3 Randomized Double-blind 2-arm Parallel-group Placebo-controlled Study to Evaluate the Efficacy and Safety of BNC210 for the Acute As-needed Treatment of Anxiety in Adults with Social Anxiety Disorder
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AFFIRM-1
Brief Summary:
The purpose of the study is to evaluate the effect of a single acute dose of BNC210 compared to placebo on reducing the severity of anxiety provoked by a behavioral assessment task and measured using the Subjective Units of Distress Scale SUDS in adult patients with social anxiety disorder
Detailed Description:
This is a randomized double-blind placebo-controlled 2-arm parallel-group multi-center study Participants will attend a Screening Visit to confirm eligibility and then return to the clinic within 21 days to be randomized into the study Randomized participants will receive a single dose of their allocated study medication 225 mg BNC210 or placebo and approximately 1 hour later participate in a behavioral assessment task After 1 week a safety follow-up assessment will be conducted by phonevideo conference
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None