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.
Ann Childress, Matthew Brams, Michael J Cattaneo et al.
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In 30 seconds
This 5-week, phase 3, randomized, double-blind, fixed-dose, placebo-controlled trial evaluated once-daily trimodal dexmethylphenidate (CTx-1301) in children and adolescents aged 6–17 years with ADHD. Among 103 participants, the 25.0- and 37.5-mg doses significantly improved ADHD Rating Scale, Version 5 scores from baseline compared with placebo (p ≤ 0.011); significance was not reported across all dose groups. More than 60% of CTx-1301 recipients were rated much or very much improved on CGI-I, compared with 18% receiving placebo. Adverse events were mild or moderate, with no new safety signals identified.
Key findings
- CTx-1301 at 25.0 or 37.5 mg improved ADHD-RS-5 scores versus placebo (p ≤ 0.011).
- More than 60% of CTx-1301 recipients were much or very much improved on CGI-I, compared with 18% on placebo.
- CGI-S improvement was statistically significant for CTx-1301 37.5 mg versus placebo (p < 0.001).
- All adverse events were mild or moderate, and no new safety signals were identified during the 5-week trial.
Why it matters
The trial provides controlled evidence that a once-daily trimodal dexmethylphenidate formulation can improve ADHD symptoms over five weeks in children and adolescents. The dose-specific results and improvement ratings offer useful efficacy and short-term tolerability information, while the lack of consistent statistical significance across doses and the preliminary nature of the findings temper interpretation.
What to keep in mind
The study included 103 participants and lasted 5 weeks; the authors describe the findings as preliminary and call for confirmation in larger, adequately powered studies.