Poster
141
(#141) Comparison of Caregiver Exit Survey With Efficacy Measures in the Treatment of ADHD with Centanafadine in a Pediatric Population
Psych Congress 2025
Abstract: Hypothesis/Objective: To compare efficacy measures and caregiver-completed exit survey data for children and adolescents treated for ADHD with centanafadine (CTN)-a norepinephrine, dopamine, serotonin reuptake inhibitor.
Methods: Two phase 3 trials evaluated the efficacy and safety of once-daily extended-release CTN for ADHD treatment (ages 6-12y and 13-17y, respectively). Participants were randomized (1:1:1) to high-dose CTN, low-dose CTN, or placebo for 6 weeks (weight-based dosing for children). Efficacy endpoints included changes from baseline in ADHD-RS-5 symptoms total raw score, CGI-S, and PGI-S (analyzed via mixed-effect model for repeated measures) and CGI-C (analyzed via Cochran-Mantel-Haenszel test). Caregivers completed an entry survey at study start and an exit survey at trial conclusion. Values presented reflect those who selected either somewhat or much better.
Results: In both trials, high-dose CTN demonstrated greater differences at Week 6 in the primary endpoint (change from baseline in ADHD-RS-5) and secondary endpoints (CGI-S, PGI-S, and CGI-C) when compared to placebo. Per the caregiver-reported exit survey, of those treated with high-dose CTN, 75% (vs 49% placebo) of adolescents and 59% (vs 50% placebo) of children saw improvement in ADHD symptoms. Similarly, 62% (vs 42% placebo) of adolescents and 56% (vs 45% placebo) of children saw improvement in behavior at home and 47% (vs 27% placebo) of adolescents and 47% (vs 38% placebo) of children saw improvement in behavior at school.
Conclusions: Consistent with efficacy measures, caregiver-reported perceptions of ADHD symptom improvement and better behavior at home/school were observed at Week 6 following CTN treatment when compared with placebo.
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 improvement in ADHD symptoms rated by clinical efficacy measures which were further supported by caregiver-reported exit survey responses.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization, Inc.
Methods: Two phase 3 trials evaluated the efficacy and safety of once-daily extended-release CTN for ADHD treatment (ages 6-12y and 13-17y, respectively). Participants were randomized (1:1:1) to high-dose CTN, low-dose CTN, or placebo for 6 weeks (weight-based dosing for children). Efficacy endpoints included changes from baseline in ADHD-RS-5 symptoms total raw score, CGI-S, and PGI-S (analyzed via mixed-effect model for repeated measures) and CGI-C (analyzed via Cochran-Mantel-Haenszel test). Caregivers completed an entry survey at study start and an exit survey at trial conclusion. Values presented reflect those who selected either somewhat or much better.
Results: In both trials, high-dose CTN demonstrated greater differences at Week 6 in the primary endpoint (change from baseline in ADHD-RS-5) and secondary endpoints (CGI-S, PGI-S, and CGI-C) when compared to placebo. Per the caregiver-reported exit survey, of those treated with high-dose CTN, 75% (vs 49% placebo) of adolescents and 59% (vs 50% placebo) of children saw improvement in ADHD symptoms. Similarly, 62% (vs 42% placebo) of adolescents and 56% (vs 45% placebo) of children saw improvement in behavior at home and 47% (vs 27% placebo) of adolescents and 47% (vs 38% placebo) of children saw improvement in behavior at school.
Conclusions: Consistent with efficacy measures, caregiver-reported perceptions of ADHD symptom improvement and better behavior at home/school were observed at Week 6 following CTN treatment when compared with placebo.
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 improvement in ADHD symptoms rated by clinical efficacy measures which were further supported by caregiver-reported exit survey responses.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization, Inc.
