A Randomized, Controlled Laboratory Classroom Study of Serdexmethylphenidate and d-Methylphenidate Capsules in
Scott H Kollins1,2, Rene Braeckman3, Sven Guenther3
1Duke ADHD Program, Durham, North Carolina, USA.
Insights
Serdexmethylphenidate/dexmethylphenidate (SDX/d-MPH) capsules effectively improved attention-deficit/hyperactivity disorder (ADHD) symptoms in children aged 6-12 compared to placebo. This ADHD treatment demonstrated a rapid onset and extended duration of action with a favorable safety profile.
Area of Science:
- Pharmacology
- Neuroscience
- Pediatric Psychiatry
Background:
- Attention-deficit/hyperactivity disorder (ADHD) is a prevalent neurodevelopmental disorder in children.
- Stimulant medications are a cornerstone of ADHD treatment, but optimal dosing and duration of effect remain critical considerations.
- Serdexmethylphenidate/dexmethylphenidate (SDX/d-MPH) is a novel, once-daily oral formulation designed for extended symptom control.
Purpose of the Study:
- To assess the efficacy and safety of once-daily SDX/d-MPH compared to placebo in pediatric patients diagnosed with ADHD.
- To determine the onset and duration of therapeutic effect in a controlled laboratory classroom setting.
- To evaluate the safety and tolerability profile of SDX/d-MPH in children aged 6-12 years.
Main Methods:
- A randomized, double-blind, placebo-controlled, dose-optimized laboratory classroom study was conducted in children (6-12 years) with ADHD.
- Participants underwent a 3-week open-label dose optimization phase followed by a 7-day double-blind treatment phase comparing optimal SDX/d-MPH dose to placebo.
- Efficacy was measured using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale and the Permanent Product Measure of Performance (PERMP). Safety was monitored via adverse events, vital signs, and electrocardiograms.
Main Results:
- SDX/d-MPH demonstrated statistically significant improvements in mean postdose SKAMP-Combined scores compared to placebo (p < 0.001).
- Significant treatment effects were observed from 1 to 10 hours postdose, with a potential onset as early as 0.5 hours and duration up to 13 hours.
- Both PERMP-Attempted and PERMP-Correct scores showed significant improvement with SDX/d-MPH versus placebo (p < 0.001).
- No serious adverse events were reported; common adverse events included insomnia and decreased appetite, consistent with stimulant treatments.
Conclusions:
- Once-daily SDX/d-MPH is an effective treatment for ADHD symptoms in children aged 6-12, showing rapid onset and sustained efficacy.
- The medication was found to be safe and well-tolerated, with an adverse event profile comparable to other stimulant therapies.
- SDX/d-MPH offers a promising therapeutic option for managing pediatric ADHD, addressing the need for extended symptom control.
Abstract:
To evaluate the efficacy and safety of once-daily serdexmethylphenidate/dexmethylphenidate (SDX/d-MPH) capsules (Azstarys™) compared with placebo in children with attention-deficit/hyperactivity disorder (ADHD) in a randomized, double-blind, dose-optimized laboratory classroom study. Children ages 6-12 with ADHD were enrolled. During a 3-week, open-label, Dose Optimization Phase, subjects initiated treatment with 39.2 mg/7.8 mg/day of SDX/d-MPH and were titrated weekly to an optimal dose (maximum dose of 52.3/10.4 mg). During the double-blind Treatment Phase, subjects were randomized to receive their optimal dose of SDX/d-MPH or placebo for 7 days. On day 7, efficacy was assessed in the laboratory classroom using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale and Permanent Product Measure of Performance (PERMP). To evaluate safety, adverse events (AEs), vital signs, and electrocardiograms were assessed, and suicide risk was assessed. A total of 149 subjects completed the study. In the primary efficacy analysis, the mean postdose change from baseline in SKAMP-Combined scores averaged over the laboratory classroom day was significantly improved with SDX/d-MPH versus placebo (least-squares mean treatment difference [95% confidence interval]: -5.41 [-7.10 to -3.71]; p < 0.001). A significant treatment effect for SDX/d-MPH compared with placebo was observed from 1 to 10 hours postdose. A post hoc analysis more comparable with that conducted in similar studies indicated a 0.5- to 13-hour onset and duration of efficacy. Both average postdose PERMP-Attempted and PERMP-Correct score changes from baseline were significantly improved among those treated with SDX/d-MPH versus placebo (p < 0.001 for both). No serious AEs were reported. During the Dose Optimization Phase, two-thirds of subjects reported AEs; the most common being insomnia and decreased appetite. SDX/d-MPH showed significant improvement in ADHD symptoms compared with placebo in children 6-12 years of age, with a rapid onset and extended duration of treatment effect. SDX/d-MPH was safe, with AEs comparable with those observed with other stimulant treatments.
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