Ignite Creation Date:
2024-07-17 @ 10:42 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483789
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-26
Brief Title:
Efficacy and Safety of HB-1 for Panic Disorder
Sponsor:
Honeybrains Biotech LLC
Organization:
Honeybrains Biotech LLC
Study Overview
Official Title:
Efficacy and Safety of HB-1 for Panic Disorder A Multicenter Randomized Double-Blind Placebo-Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
The purpose of this study is to determine the safety and efficacy of HB-1 versus placebo and two monotherapies in male and female adult patients aged 18 to 65 years inclusive with Panic Disorder
Detailed Description:
This is a multicenter randomized double-blind placebo-controlled trial All patients with Panic Disorder with or without specified co-morbidities who meet all of the inclusion and none of the exclusion criteria will be eligible Patients and researchers will be blinded to their treatment group
The study will enroll approximately 240 up to 600 adult patients who meet the diagnosis of panic disorder
Patients will be treated for 12 weeks followed by a safety follow up visit one week after their last dose of study treatment
The study will enroll approximately 240 up to 600 adult patients who meet the diagnosis of panic disorder
Patients will be treated for 12 weeks followed by a safety follow up visit one week after their last dose of study treatment
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?:
True
Is an FDA AA801 Violation?:
None