Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05924594
Status:
SUSPENDED
Last Update Posted:
2024-01-23
First Post:
2023-06-21
Brief Title:
Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics 6-12 With ADHD Using CTx-1301
Sponsor:
Cingulate Therapeutics
Organization:
Cingulate Therapeutics
Study Overview
Official Title:
A Phase 3 Dose-Optimized Double-Blind Randomized Placebo-Controlled Parallel Efficacy and Safety Laboratory Classroom Study in Children 6-12 With Attention-DeficitHyperactivity Disorder ADHD Using CTx-1301 Dexmethylphenidate
Status:
SUSPENDED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Continuation of the study is not required for NDA submission via the 505b2 pathway
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the efficacy and safety of CTx-1301 in children 6-12 with ADHD in a laboratory classroom setting
Detailed Description:
A Phase 3 dose-optimized randomized double-blind placebo-controlled dose-optimized parallel efficacy and safety laboratory classroom study in children 6-12 with ADHD
The study will be comprised of a screening period a dose-optimization phase a double-blind randomized phase and a safety follow-up phase Subjects will undergo a screening visit prior to entering into a 8-week dose-optimization phase During the dose-optimization phase subjects will have weekly visits and will be titrated to doses ranging between 625mg-375mg of CTx-1301 Eligible subjects will be randomized phase to their optimal dose or placebo in a 11 ratio at the end of Visit 10 completing the practice laboratory classroom study Subjects will take their assignedrandomized dose over the following 7-day period On the 7th days subjects will complete the full laboratory classroom study The duration of the full laboratory classroom study will be approximately 15 hours Subjects will have an in-clinic safety follow-up visit within 7 days after the full classroom day
The study will be comprised of a screening period a dose-optimization phase a double-blind randomized phase and a safety follow-up phase Subjects will undergo a screening visit prior to entering into a 8-week dose-optimization phase During the dose-optimization phase subjects will have weekly visits and will be titrated to doses ranging between 625mg-375mg of CTx-1301 Eligible subjects will be randomized phase to their optimal dose or placebo in a 11 ratio at the end of Visit 10 completing the practice laboratory classroom study Subjects will take their assignedrandomized dose over the following 7-day period On the 7th days subjects will complete the full laboratory classroom study The duration of the full laboratory classroom study will be approximately 15 hours Subjects will have an in-clinic safety follow-up visit within 7 days after the full classroom day
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