Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358651
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-04-04
Brief Title:
Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder PALISADE-3
Sponsor:
VistaGen Therapeutics Inc
Organization:
VistaGen Therapeutics Inc
Study Overview
Official Title:
US Phase 3 Multicenter Randomized Double-blind Placebo-controlled Clinical Trial of Fasedienol Nasal Spray for the Acute Treatment of Anxiety Induced by a Public Speaking Challenge in Adult Subjects With Social Anxiety Disorder With an Open-Label Extension PALISADE-3
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PALISADE-3
Brief Summary:
This US Phase 3 clinical trial is designed to evaluate the efficacy safety and tolerability of the acute intranasal in administration of Fasedienol Nasal Spray fasedienol 32 µg to relieve symptoms of acute anxiety in adult subjects ages 18 through 65 with Social Anxiety Disorder induced by a public speaking challenge PSC in a clinical setting In addition safety and tolerability of in administration of 32 µg of fasedienol as-needed up to 6 times per day for up to 12 months will be assessed in those subjects who complete PALISADE-3 and choose to enter the distinct open-label extension phase of the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None