NCT05631626

Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301.

A Phase 3, Dose-Optimized, Randomized, Double-Blind, Placebo-Controlled, Single-Center, Parallel Efficacy and Safety Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) Using CTx-1301 (Dexmethylphenidate)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Cingulate Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of CTx-1301 in adults with ADHD in a laboratory classroom setting.

Detailed description

A single-center, dose-optimized, double-blind, randomized, placebo-controlled, parallel efficacy and safety laboratory classroom study with CTx-1301 in approximately 25 adults aged 18 to 55 years 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 a 5-week dose-optimization phase. During the dose-optimization phase subjects will have weekly visit and will be titrated to doses ranging between 25mg-50mg of CTx-1301. Eligible subjects will be randomized to their optimal dose or placebo in a 1:1 ratio after completing a practice Adult Laboratory Classroom (ALC) visit with 4 PERMP assessments. Subjects will take their assigned/randomized dose over the following 7-day period. On the 7th day subjects will complete a full ALC visit. The duration of the full ALC visit will be approximately 17 hours. Subjects will have an in-clinic safety follow-up visit within 7 days after the full adult laboratory classroom visit.

Conditions

• ADHD
• ADHD - Combined Type
• Attention Deficit Hyperactivity Disorder Combined
• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	CTx-1301 - Dexmethylphenidate 25mg	25mg CTx-1301 (Dexmethylphenidate tablet)
DRUG	CTx-1301 - Dexmethylphenidate 37.5mg	37.5mg CTx-1301 (Dexmethylphenidate tablet)
DRUG	CTx-1301 - Dexmethylphenidate 50mg	50mg CTx-1301 (Dexmethylphenidate tablet)
DRUG	Placebo	Placebo

Timeline

• Start date: 2022-12-29
• Primary completion: 2023-06-13
• Completion: 2023-06-13
• First posted: 2022-11-30
• Last updated: 2025-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study