Abstracts
3427195
(#3) Efficacy of Centanafadine in Children and Adolescents With ADHD and High Baseline Emotional Dysregulation: 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 (aged 6-12 years) and adolescents (aged 13-17 years). This post hoc analysis assesses efficacy in a pooled subgroup of children and adolescents with high-baseline emotional dysregulation.
Methods: High-baseline emotional dysregulation was defined as a baseline Conners 3-Parent Short (PS) Defiance/Aggression content scale T-score of ≥70 (proxy for emotional dysregulation), which is considered "very elevated." Endpoints analyzed in this subgroup included, change from baseline through Week 6 in ADHD Rating Scale-5 (ADHD-RS-5) Symptoms total raw score and the 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, 188 participants were treated with centanafadine (n=92) or placebo (n=96) and had a Conners 3-PS Defiance/Aggression T-score ≥70 at baseline. In the ADHD-RS-5 total score and Conners 3-PS Inattention, Executive Function, and Learning problems content scales, participants with high-baseline emotional dysregulation saw greater improvements at each timepoint measured over Weeks 1-6 (P 0.05) when compared to placebo. P-values (P 0.05) were achieved at most, but not all, time points for Hyperactivity/Impulsivity and Defiance/Aggression content scales. No new safety concerns were identified in this subgroup population compared to overall trial populations.
Conclusions: Children and adolescents with high baseline levels of emotional dysregulation saw greater improvements in core symptoms and ADHD associated features when treated with centanafadine 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 emotional dysregulation. When compared to placebo, centanafadine treatment led to greater improvements in ADHD core symptoms and associated features in those with high-baseline emotional dysregulation 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 emotional dysregulation was defined as a baseline Conners 3-Parent Short (PS) Defiance/Aggression content scale T-score of ≥70 (proxy for emotional dysregulation), which is considered "very elevated." Endpoints analyzed in this subgroup included, change from baseline through Week 6 in ADHD Rating Scale-5 (ADHD-RS-5) Symptoms total raw score and the 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, 188 participants were treated with centanafadine (n=92) or placebo (n=96) and had a Conners 3-PS Defiance/Aggression T-score ≥70 at baseline. In the ADHD-RS-5 total score and Conners 3-PS Inattention, Executive Function, and Learning problems content scales, participants with high-baseline emotional dysregulation saw greater improvements at each timepoint measured over Weeks 1-6 (P 0.05) when compared to placebo. P-values (P 0.05) were achieved at most, but not all, time points for Hyperactivity/Impulsivity and Defiance/Aggression content scales. No new safety concerns were identified in this subgroup population compared to overall trial populations.
Conclusions: Children and adolescents with high baseline levels of emotional dysregulation saw greater improvements in core symptoms and ADHD associated features when treated with centanafadine 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 emotional dysregulation. When compared to placebo, centanafadine treatment led to greater improvements in ADHD core symptoms and associated features in those with high-baseline emotional dysregulation 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
