Impact of Centanafadine on Conners 3 Inattention and Hyperactivity/Impulsivity Content Scales in Pediatric Patients With Attention-Deficit/Hyperactivity Disorder
Hypothesis/Objective: To evaluate the impact of centanafadine (CTN), a norepinephrine, dopamine, serotonin reuptake inhibitor, on inattention and hyperactivity/impulsivity via caregiver-report and/or self-report in a pediatric population with ADHD.
Methods: In two phase 3 trials (children [6–12y] and adolescent [13–17y]) patients were randomized to high-dose CTN, low-dose CTN, or placebo for 6 weeks; in children, CTN dosing was weight-based. Efficacy outcomes included the Conners 3-Parent Short (PS; caregiver perspective for both children and adolescents) inattention and hyperactivity/impulsivity content scale T-scores, with adolescents also completing the Conners 3-Self-report Short (SRS); both analyzed using a mixed model for repeated measures. Values are presented as LS mean change from baseline (standard error). P-values were not controlled for multiplicity and are descriptive.
Results: In children, significant improvements with high-dose CTN versus placebo were observed at Week 6 (inattention: −11.9 [1.1] vs −6.4 [1.1], P=0.0002; hyperactivity/impulsivity: −11.5 [1.1] vs −6.9 [1.1], P=0.0022). For adolescents, significant improvements were observed in inattention at Week 6 per Conners 3-PS T-scores for high-dose CTN versus placebo (−14.4 [1.0] vs −8.1 [1.0], P < 0.0001) and Conners 3-SRS (−15.3 [1.1] vs −10.0 [1.0], P=0.0001), as well as in hyperactivity/impulsivity for high-dose CTN versus placebo on the Conners 3-PS (−14.0 [1.1] vs −8.5 [1.1], P=0.0002) and Conners 3-SRS (−11.6 [0.9] vs −8.9 [0.9], P=0.0282) T-scores at Week 6.
Conclusions: High-dose CTN showed improvement in core symptoms on the Conners 3 content scales of inattention and hyperactivity/impulsivity in pediatric patients when compared with placebo, with greater caregiver and adolescent perceptions of symptom improvement.
