Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301

Attention Deficit Hyperactivity Disorder Clinical Trial

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 Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• ADHD
• ADHD - Combined Type
• Attention Deficit Disorder With Hyperactivity
• Attention Deficit Hyper Activity
• Attention Deficit Hyperactivity Disorder
• Attention Deficit Hyperactivity Disorder Combined
• Attention-deficit Hyperactivity
• Hyperkinesis

• NCT number: NCT05924594
• Study type: Interventional
• Source: Cingulate Therapeutics
• Contact: Kelly Kramer AD, Clinical Operations
• Phone: (913)942-2300
• Email: kkramer@cingulate.com
• Status: Recruiting
• Phase: Phase 3
• Start date: July 31, 2023
• Completion date: April 2024