Abstracts
3427204
(#8) Efficacy of Centanafadine in Children and Adolescents With ADHD and High Baseline Executive Dysfunction: A Post Hoc Analysis of Two Phase 3 Trials
Abstract: Introduction: Two phase 3 clinical trials assessed the safety and efficacy of once-daily extended-release centanafadine, a norepinephrine, dopamine, and serotonin reuptake inhibitor, for the treatment of ADHD in children (6-12y) and adolescents (13-17y). This post hoc analysis assesses efficacy in a pooled subgroup of children and adolescents with high-baseline executive dysfunction.
Methods: High-baseline executive dysfunction was defined as a Conners 3-Parent Short (PS) Executive Function content scale T-score of ≥70 ("very elevated"). Endpoints analyzed included, change from baseline through Week 6 in ADHD Rating Scale-5 (ADHD-RS-5) Symptoms total raw score and Conners 3-PS Inattention, Hyperactivity/Impulsivity, Defiance/Aggression, Executive Function, and Learning Problems content scale T-scores. P-values were not adjusted for multiplicity.
Results: Overall, 435 participants treated with centanafadine (n=210) or placebo (n=225) had a Conners 3-PS Executive Function T-score ≥70 at baseline. For ADHD-RS-5 and Conners 3-PS Inattention, Hyperactivity/Impulsivity, Executive Function, and Learning Problems content scales, participants with high-baseline executive dysfunction had greater improvements at each timepoint over Weeks 1-6 (P 0.001) compared to placebo. At Week 6, more participants with high baseline executive dysfunction treated with centanafadine than placebo shifted to a Conners 3-PS Executive Function T-Score 65 (42% vs 26%; P 0.001, respectively), indicative of average/mildly elevated executive dysfunction. No new safety concerns were identified in this subgroup.
Conclusions: When treated with centanafadine, children and adolescents with very elevated levels of executive dysfunction at baseline saw greater improvements in core and associated symptoms of ADHD when compared to placebo.
Short Description: A post hoc analysis was performed utilizing data from two phase 3 clinical trials of centanafadine-a norepinephrine, dopamine, and serotonin reuptake inhibitor-to assess efficacy in a pooled subgroup of children and adolescents with high-baseline executive dysfunction. When compared to placebo, centanafadine treatment led to greater improvements in ADHD core symptoms and associated features in those with high-baseline executive dysfunction as measured by the ADHD-RS-5 and Conners 3-Parent Short.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, United States
Methods: High-baseline executive dysfunction was defined as a Conners 3-Parent Short (PS) Executive Function content scale T-score of ≥70 ("very elevated"). Endpoints analyzed included, change from baseline through Week 6 in ADHD Rating Scale-5 (ADHD-RS-5) Symptoms total raw score and Conners 3-PS Inattention, Hyperactivity/Impulsivity, Defiance/Aggression, Executive Function, and Learning Problems content scale T-scores. P-values were not adjusted for multiplicity.
Results: Overall, 435 participants treated with centanafadine (n=210) or placebo (n=225) had a Conners 3-PS Executive Function T-score ≥70 at baseline. For ADHD-RS-5 and Conners 3-PS Inattention, Hyperactivity/Impulsivity, Executive Function, and Learning Problems content scales, participants with high-baseline executive dysfunction had greater improvements at each timepoint over Weeks 1-6 (P 0.001) compared to placebo. At Week 6, more participants with high baseline executive dysfunction treated with centanafadine than placebo shifted to a Conners 3-PS Executive Function T-Score 65 (42% vs 26%; P 0.001, respectively), indicative of average/mildly elevated executive dysfunction. No new safety concerns were identified in this subgroup.
Conclusions: When treated with centanafadine, children and adolescents with very elevated levels of executive dysfunction at baseline saw greater improvements in core and associated symptoms of ADHD when compared to placebo.
Short Description: A post hoc analysis was performed utilizing data from two phase 3 clinical trials of centanafadine-a norepinephrine, dopamine, and serotonin reuptake inhibitor-to assess efficacy in a pooled subgroup of children and adolescents with high-baseline executive dysfunction. When compared to placebo, centanafadine treatment led to greater improvements in ADHD core symptoms and associated features in those with high-baseline executive dysfunction as measured by the ADHD-RS-5 and Conners 3-Parent Short.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, United States
