A Phase 3, Multicenter, Randomized, Placebo-Controlled Trial Evaluating the Efficacy, Safety, and Tolerability of Serdexmethylphenidate/d-Methylphenidate Capsules in Chinese Children with Attention-Deficit/Hyperactivity Disorder.
Serdexmethylphenidate/dexmethylphenidate (SDX/d-MPH) is a novel methylphenidate formulation designed to provide rapid onset and sustained symptom control in attention-deficit/hyperactivity disorder (ADHD). This phase 3 study evaluated its efficacy, safety, and tolerability in Chinese children with ADHD.
This multicenter, randomized, double-blind, placebo-controlled bridging study enrolled children aged 6-12 years who met DSM-5 criteria for ADHD. The primary endpoint was least squares mean (LSM) change from baseline to week 3 in ADHD Rating Scale-5 (ADHD-RS-5) total score, an 18-item DSM-5-based scale rating symptoms from 0 (never/rarely) to 3 (very often). Secondary endpoints included change from baseline to week 4 in ADHD-RS-5, and weekly changes in Clinical Global Impressions-Severity (CGI-S), Clinical Global Impressions-Improvement (CGI-I), and Weekly Ratings of Evening and Morning Behavior-Revised (WREMB-R). Safety was assessed throughout the study.
Overall, 55 participants were randomized (SDX/d-MPH, n = 28; placebo, n = 27). At week 3, SDX/d-MPH demonstrated significantly greater improvement in ADHD-RS-5 total score versus placebo (between-group LSM change [standard error]: - 5.8 [2.58], p = 0.0292), with an effect size of 0.61, meeting the prespecified efficacy consistency criterion (≥ 0.25). At week 4, significant improvements versus placebo were observed across ADHD-RS-5 total score (- 8.4 [2.69]), inattention and hyperactivity-impulsivity sub-scores (- 4.4 [1.69] and - 3.7 [1.27], respectively), CGI-S (- 0.8 [0.28]), CGI-I (0.9 [0.27]), and WREMB-R total (- 3.7 [1.35]) and evening scores (- 3.2 [1.03]). Most treatment-emergent adverse events were mild to moderate, with no new safety signals.
SDX/d-MPH significantly improved ADHD symptoms and was generally well tolerated in Chinese children, supporting extension of global trial results to this population.
gov identifier: NCT06359899 (registered on 25 March 2024).
This multicenter, randomized, double-blind, placebo-controlled bridging study enrolled children aged 6-12 years who met DSM-5 criteria for ADHD. The primary endpoint was least squares mean (LSM) change from baseline to week 3 in ADHD Rating Scale-5 (ADHD-RS-5) total score, an 18-item DSM-5-based scale rating symptoms from 0 (never/rarely) to 3 (very often). Secondary endpoints included change from baseline to week 4 in ADHD-RS-5, and weekly changes in Clinical Global Impressions-Severity (CGI-S), Clinical Global Impressions-Improvement (CGI-I), and Weekly Ratings of Evening and Morning Behavior-Revised (WREMB-R). Safety was assessed throughout the study.
Overall, 55 participants were randomized (SDX/d-MPH, n = 28; placebo, n = 27). At week 3, SDX/d-MPH demonstrated significantly greater improvement in ADHD-RS-5 total score versus placebo (between-group LSM change [standard error]: - 5.8 [2.58], p = 0.0292), with an effect size of 0.61, meeting the prespecified efficacy consistency criterion (≥ 0.25). At week 4, significant improvements versus placebo were observed across ADHD-RS-5 total score (- 8.4 [2.69]), inattention and hyperactivity-impulsivity sub-scores (- 4.4 [1.69] and - 3.7 [1.27], respectively), CGI-S (- 0.8 [0.28]), CGI-I (0.9 [0.27]), and WREMB-R total (- 3.7 [1.35]) and evening scores (- 3.2 [1.03]). Most treatment-emergent adverse events were mild to moderate, with no new safety signals.
SDX/d-MPH significantly improved ADHD symptoms and was generally well tolerated in Chinese children, supporting extension of global trial results to this population.
gov identifier: NCT06359899 (registered on 25 March 2024).
Authors
Liu Liu, Yang Yang, Wang Wang, Chen Chen, Yang Yang, Cui Cui, Zhang Zhang, Liu Liu, He He, Yang Yang, Xu Xu, Sun Sun, Aisikeer Aisikeer, Fan Fan, Liu Liu, Wang Wang, Sun Sun, Jia Jia, Qi Qi, Wu Wu, Zheng Zheng
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