NCT05257265

A Trial of Centanafadine Efficacy and Safety in Adolescents With Attention- Deficit/Hyperactivity Disorder

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Determine the Efficacy and Safety of Once Daily Centanafadine Capsules for the Treatment of Adolescents With Attention-deficit/Hyperactivity Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 459 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This trial was conducted to evaluate the efficacy and safety of the Centanafadine once daily (QD) extended release (XR) capsules in adolescent participants (13 - 17 years, inclusive) with attention-deficit/hyperactivity disorder (ADHD).

Detailed description

The trial consisted of a screening period of up to 28 days (4 weeks), a 42-day (6-week) double-blind treatment period, and a 7 (+ 2)-day follow-up period.

Conditions

• Attention-Deficit/Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Centanafadine Hydrochloride	Capsule
OTHER	Placebo	Capsule

Timeline

• Start date: 2022-02-02
• Primary completion: 2023-09-29
• Completion: 2023-10-05
• First posted: 2022-02-25
• Last updated: 2024-09-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study