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