Analysis of Daily Sleep Diary Measures From Multilayer Extended-Release Methylphenidate (PRC-063) Studies in Children
Marc Cataldo1, Graeme Donnelly2, Andrew J Cutler3
1Purdue Pharma L.P., Stamford, CT, USA.
Insights
Extended-release methylphenidate (PRC-063) did not affect sleep in children or adults with attention deficit hyperactivity disorder (ADHD). This study found no statistical differences in sleep time, efficiency, or latency compared to placebo.
Area of Science:
- Pharmacology
- Neuroscience
- Clinical Psychology
Background:
- Attention deficit hyperactivity disorder (ADHD) is a common neurodevelopmental disorder.
- Sleep disturbances are frequently reported in individuals with ADHD.
- Extended-release stimulant medications are a primary treatment for ADHD.
Purpose of the Study:
- To evaluate the impact of a novel once-daily extended-release methylphenidate formulation (PRC-063) on sleep.
- To compare subjective sleep measures between PRC-063 and placebo in pediatric and adult ADHD patients.
Main Methods:
- Two randomized, double-blind, placebo-controlled trials were conducted in pediatric (6-12 years) and adult (≥18 years) patients with ADHD.
- Patients completed daily electronic sleep diaries during a 1-week double-blind treatment period.
- Sleep parameters assessed included total sleep time, sleep efficiency, and sleep latency.
Main Results:
- A total of 148 pediatric and 239 adult patients were randomized.
- No statistically significant differences were observed in total sleep time, sleep efficiency, or sleep latency between the PRC-063 and placebo groups.
- These findings were consistent in both pediatric and adult cohorts.
Conclusions:
- The extended-release methylphenidate formulation (PRC-063) did not subjectively impact sleep in pediatric and adult patients with ADHD.
- PRC-063 appears to be a safe option regarding sleep quality in ADHD patients.
Objective:
To compare the effect of a once-daily extended-release methylphenidate formulation (PRC-063) versus placebo on sleep, measured via daily electronic diary in two clinical trials in pediatric (6-12 years) and adult (≥18 years) patients with attention deficit hyperactivity disorder (ADHD).
Method:
A diary was completed by adult patients or parents/caregivers of pediatric patients during two randomized, double-blind, placebo-controlled laboratory classroom studies. Following dose optimization of PRC-063, patients were randomized to 1 week of double-blind treatment with PRC-063 or placebo before attending a full-day laboratory classroom session.
Results:
In the studies, 148 pediatric patients and 239 adult patients were randomized to either PRC-063 or placebo. When compared with the diaries of placebo patients, the sleep diaries in both pediatric and adult patients showed no statistical difference in total sleep time, efficiency, or latency.
Conclusion:
PRC-063 did not impact subjective measures of sleep versus placebo in pediatric and adult patients with ADHD.
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