A Trial of Centanafadine Long-term Safety in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)
A Trial of Centanafadine Long-term Safety in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)
ClinicalTrials.gov ID: NCT05279313
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by: Otsuka Pharmaceutical Development & Commercialization, Inc. (Responsible Party)
Last Update Posted: 2023-04-12
Brief Summary:
The primary purpose of this trial is to evaluate the safety and tolerability of centanafadine QD XR in pediatric subjects with ADHD.
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). 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 the last subject enrolled reaches 52 weeks of study treatment.
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 With Attention-deficit/Hyperactivity Disorder (ADHD)
Intervention / Treatment:
- Drug: Centanafadine Hydrochloride
| Category | Value |
|---|---|
| Study Start (Actual) |
2022-02-24
|
| Primary Completion (Estimated) | 2024-11-20 |
| Study Completion (Estimated) | 2024-11-27 |
| Enrollment (Estimated) | 700 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
405-201-00017 |