NCT05279313

A Trial of Centanafadine Long-term Safety in Children and Adolescents With Attention-deficit/Hyperactivity Disorder.

A Phase 3, Multicenter, Open-label, Long-term Trial Evaluating the Long-term Safety and Tolerability of Once Daily Centanafadine Capsules in Children and Adolescents (4 to 17 Years of Age, Inclusive) With Attention-deficit/Hyperactivity Disorder (ADHD).

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 680 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 4 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate long-term safety exposure

Detailed description

This open-label study will assess the overall safety and tolerability of centanafadine once daily extended-release capsules in pediatric subjects (ages 4-17 years). The study will accept rollover subjects from double-blind parent trials and individuals that did not participate in one of the double-blind parent trials, may enroll as De Novo subjects after meeting all required study entry criteria. All subjects will complete a minimum of 52 weeks and may continue until all enrolled subjects within the age group the subject was in at the start of their participation in the trial (13 to 17 years; 6 to 12 years; 4 to 5 years) have had a chance to reach the Week 52 visit.

Conditions

• Attention Deficit/Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Centanafadine Hydrochloride	Capsule

Timeline

• Start date: 2022-02-24
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2022-03-15
• Last updated: 2026-01-27

Locations

86 sites across 3 countries: United States, Canada, Puerto Rico

Regulatory

• FDA-regulated drug study