Journal of child and adolescent psychopharmacology · 2026
Efficacy and Safety of Trimodal Dexmethylphenidate (CTx-1301) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: Results From a Phase 3, Randomized, Double-Blind, Fixed-Dose, Placebo-Controlled Trial.
СтатьяНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Childress Ann, Brams Matthew, Cattaneo Michael J, Silva Raul
Аннотация
BACKGROUND: CTx-1301 is the first trimodal dexmethylphenidate formulation developed for the treatment of attention-deficit/hyperactivity disorder (ADHD).
METHODS: In this 5-week, phase 3, fixed-dose study, patients with ADHD aged 6-17 years were randomized to once-daily treatment with CTx-1301 (18.75, 25.0, or 37.5 mg) or placebo. CTx-1301 was initiated at 12.5 mg and uptitrated weekly to reach the assigned fixed dose. The primary endpoint was the change from baseline to week 5 in the ADHD Rating Scale, Version 5 (ADHD-RS-5). Secondary efficacy endpoints included Clinical Global Impression-Severity (CGI-S) and -Improvement (CGI-I). Statistical comparisons were evaluated at a Bonferroni-adjusted significance level of 0.017.
RESULTS: The mean age (±standard deviation) of the study population (N = 103) was 11.3 ± 3.3 years, and the majority of subjects (60.2%) were male. Treatment with CTx-1301 25.0 or 37.5 mg significantly improved ADHD-RS-5 score from baseline compared with placebo (p ≤ 0.011). Exploratory post hoc analyses revealed effect sizes for the comparison of CTx-1301 and placebo ranging from 0.732 (18.75-mg dose) to 1.185 (37.5-mg dose). Improvement in CGI-S was statistically significant for CTx-1301 37.5 mg versus placebo (p < 0.001). More than 60% of subjects who received CTx-1301 were much to very much improved on CGI-I compared with 18% for placebo. All adverse events were mild or moderate in severity, no new safety signals were identified, and the safety profile was consistent with the known effects of dexmethylphenidate.
CONCLUSIONS: CTx-1301 demonstrated dose-related improvements in signs and symptoms of ADHD, although statistical significance is not consistent across all dose groups. The treatment was well tolerated over 5 weeks in children and adolescents with ADHD. Given the limited sample size and reduced statistical power, these findings should be considered preliminary and require confirmation in larger, adequately powered studies.
METHODS: In this 5-week, phase 3, fixed-dose study, patients with ADHD aged 6-17 years were randomized to once-daily treatment with CTx-1301 (18.75, 25.0, or 37.5 mg) or placebo. CTx-1301 was initiated at 12.5 mg and uptitrated weekly to reach the assigned fixed dose. The primary endpoint was the change from baseline to week 5 in the ADHD Rating Scale, Version 5 (ADHD-RS-5). Secondary efficacy endpoints included Clinical Global Impression-Severity (CGI-S) and -Improvement (CGI-I). Statistical comparisons were evaluated at a Bonferroni-adjusted significance level of 0.017.
RESULTS: The mean age (±standard deviation) of the study population (N = 103) was 11.3 ± 3.3 years, and the majority of subjects (60.2%) were male. Treatment with CTx-1301 25.0 or 37.5 mg significantly improved ADHD-RS-5 score from baseline compared with placebo (p ≤ 0.011). Exploratory post hoc analyses revealed effect sizes for the comparison of CTx-1301 and placebo ranging from 0.732 (18.75-mg dose) to 1.185 (37.5-mg dose). Improvement in CGI-S was statistically significant for CTx-1301 37.5 mg versus placebo (p < 0.001). More than 60% of subjects who received CTx-1301 were much to very much improved on CGI-I compared with 18% for placebo. All adverse events were mild or moderate in severity, no new safety signals were identified, and the safety profile was consistent with the known effects of dexmethylphenidate.
CONCLUSIONS: CTx-1301 demonstrated dose-related improvements in signs and symptoms of ADHD, although statistical significance is not consistent across all dose groups. The treatment was well tolerated over 5 weeks in children and adolescents with ADHD. Given the limited sample size and reduced statistical power, these findings should be considered preliminary and require confirmation in larger, adequately powered studies.