Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-06 @ 10:14 PM
Study NCT ID:
NCT05924594
Status:
SUSPENDED
Last Update Posted:
2025-08-14
First Post:
2023-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301
Sponsor:
Cingulate Therapeutics
Organization:
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-Deficit/Hyperactivity Disorder (ADHD) Using CTx-1301 (Dexmethylphenidate)
Status:
SUSPENDED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Continuation of the study is not required for NDA submission via the 505(b)(2) 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 6.25mg-37.5mg of CTx-1301. Eligible subjects will be randomized phase to their optimal dose or placebo in a 1:1 ratio at the end of Visit 10 completing the practice laboratory classroom study. Subjects will take their assigned/randomized 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 6.25mg-37.5mg of CTx-1301. Eligible subjects will be randomized phase to their optimal dose or placebo in a 1:1 ratio at the end of Visit 10 completing the practice laboratory classroom study. Subjects will take their assigned/randomized 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:
False
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?:
False
Is an FDA AA801 Violation?: