Overview

A Phase 3 Efficacy and Safety in Pediatrics (6-17) With Attention-Deficit/Hyperactivity Disorder (ADHD) Using CTx-1301 (Dexmethylphenidate)

Status:
Not yet recruiting

Trial end date:
2022-10-30

Target enrollment:

Participant gender:

Summary

A Phase 3, randomized, double-blind, placebo-controlled, multi-center, fixed-dose, parallel-group efficacy and safety study in a pediatric population (6-17) with Attention-Deficit/Hyperactivity Disorder (ADHD) using CTx-1301 (d-MPH). A multi-center, double-blind, randomized, placebo-controlled, fixed-dose, parallel efficacy and safety study with CTx-1301 in children (6-12) and adolescents (13-17) with ADHD confirmed by an ADHD-RS-5 score of at least 28 and CGI-S score of at least 4 (moderately ill) at screening. The study will be comprised of a screening period, a double-blind randomized phase, and a safety follow-up visit.

Phase:

Phase 3

Details

Lead Sponsor:

Cingulate Therapeutics

Collaborator:

Premier Research Group plc

Treatments:

Dexmethylphenidate Hydrochloride