Poster
140
(#140) Clinically Meaningful, Caregiver-Rated Improvements in ADHD Symptoms Following 6 Weeks of Centanafadine Treatment in Pediatric Patients with ADHD
Psych Congress 2025
Abstract: Hypothesis/Objective: To evaluate the clinically meaningful treatment impact of centanafadine (CTN), a norepinephrine, dopamine, serotonin reuptake inhibitor, on inattention and hyperactivity/impulsivity (H/I) symptoms in children and adolescents with ADHD.
Methods: Two phase 3 trials evaluated efficacy and safety of CTN for ADHD treatment in children and adolescents. Eligible participants with a primary ADHD diagnosis were randomized to high-dose CTN, low-dose CTN, or placebo for 6 weeks; in children, CTN dosing was weight-based. Clinically meaningful within-patient change was analyzed for key secondary endpoint, change from baseline in Conners 3-Parent Short (PS) T-scores for Inattention (≥14-point improvement) and H/I (≥13-point improvement), up to Week 6 via Cochran-Mantel-Haenszel tests. Time from randomization to reaching clinically meaningful within-patient for the first time was analyzed via a log-rank test. P-values were not controlled for multiplicity.
Results: Up to Week 6, a numerically greater proportion of participants treated with high-dose CTN had a ≥14-point improvement in Conners 3-PS Inattention T-scores and a ≥13-point improvement Conners 3-PS H/I T-scores when compared to placebo (Inattention: adolescents: 48.9% vs 30.5%, P=0.0013; children: 35.4% vs 22.8%, P=0.0174; H/I: adolescents: 49.6% vs 33.3%, P=0.0066; children: 38.1% vs 25.5%, P=0.0233). For children and adolescents, time from randomization to reaching the clinically meaningful within-patient change threshold of Conners 3-PS Inattention and H/I T-scores for the first time was significantly earlier in the high-dose CTN group when compared to placebo.
Conclusions: Compared to placebo, high-dose CTN was efficacious and well tolerated, with significant clinically meaningful within-patient change in ADHD symptoms for children and adolescents.
Short Description: ADHD is one of the most common pediatric neurodevelopmental disorders, characterized by symptoms of inattention, hyperactivity, and impulsivity. Centanafadine (CTN) is a norepinephrine, dopamine, and serotonin reuptake inhibitor under investigation for the treatment of ADHD in pediatric and adult patients. In this study, children and adolescents with ADHD treated with CTN showed clinically meaningful improvements in symptoms of inattention and hyperactivity/impulsivity.
Name of Sponsoring Organization(s): This study was supported by Otsuka Pharmaceutical Development & Commercialization, Inc.
Methods: Two phase 3 trials evaluated efficacy and safety of CTN for ADHD treatment in children and adolescents. Eligible participants with a primary ADHD diagnosis were randomized to high-dose CTN, low-dose CTN, or placebo for 6 weeks; in children, CTN dosing was weight-based. Clinically meaningful within-patient change was analyzed for key secondary endpoint, change from baseline in Conners 3-Parent Short (PS) T-scores for Inattention (≥14-point improvement) and H/I (≥13-point improvement), up to Week 6 via Cochran-Mantel-Haenszel tests. Time from randomization to reaching clinically meaningful within-patient for the first time was analyzed via a log-rank test. P-values were not controlled for multiplicity.
Results: Up to Week 6, a numerically greater proportion of participants treated with high-dose CTN had a ≥14-point improvement in Conners 3-PS Inattention T-scores and a ≥13-point improvement Conners 3-PS H/I T-scores when compared to placebo (Inattention: adolescents: 48.9% vs 30.5%, P=0.0013; children: 35.4% vs 22.8%, P=0.0174; H/I: adolescents: 49.6% vs 33.3%, P=0.0066; children: 38.1% vs 25.5%, P=0.0233). For children and adolescents, time from randomization to reaching the clinically meaningful within-patient change threshold of Conners 3-PS Inattention and H/I T-scores for the first time was significantly earlier in the high-dose CTN group when compared to placebo.
Conclusions: Compared to placebo, high-dose CTN was efficacious and well tolerated, with significant clinically meaningful within-patient change in ADHD symptoms for children and adolescents.
Short Description: ADHD is one of the most common pediatric neurodevelopmental disorders, characterized by symptoms of inattention, hyperactivity, and impulsivity. Centanafadine (CTN) is a norepinephrine, dopamine, and serotonin reuptake inhibitor under investigation for the treatment of ADHD in pediatric and adult patients. In this study, children and adolescents with ADHD treated with CTN showed clinically meaningful improvements in symptoms of inattention and hyperactivity/impulsivity.
Name of Sponsoring Organization(s): This study was supported by Otsuka Pharmaceutical Development & Commercialization, Inc.
