NCT05924594

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Cingulate Therapeutics · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	CTx-1301 - Dexmethylphenidate 6.25mg	All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg of CTx-1301.
DRUG	CTx-1301 - Dexmethylphenidate 12.5mg	All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg of CTx-1301.
DRUG	CTx-1301 - Dexmethylphenidate 18.75mg	All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg of CTx-1301.
DRUG	CTx-1301 - Dexmethylphenidate 25.0mg	All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg of CTx-1301.
DRUG	CTx-1301 - Dexmethylphenidate 31.25mg	All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg of CTx-1301.
DRUG	CTx-1301 - Dexmethylphenidate 37.5mg	All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg of CTx-1301.
DRUG	Placebo	Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomized phase.

Timeline

• Start date: 2023-07-31
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2023-06-29
• Last updated: 2025-08-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study