At a glance
ClinicalIndex Comparison Record- ✓Age 4 years to less than 5 years 10 months at Screening
- ✓Body weight between 5th and 95th percentile for age and gender (CDC charts)
- ✓DSM-5 diagnosis of ADHD (combined, inattentive, or hyperactive/impulsive), confirmed by MINI Kid
- ✓ADHD symptoms present for ≥6 months prior to Screening
- ✕Any clinically significant chronic medical condition interfering with study participation
- ✕Bipolar I or II disorder, major depressive disorder, conduct disorder, OCD, psychosis, autism spectrum disorder, DMDD, intellectual disability, Tourette's Syndrome, or confirmed genetic disorder with cognitive/behavioral disturbances
- ✕Generalized anxiety disorder or panic disorder as primary focus of treatment in past 12 months, or requiring pharmacotherapy in past 6 months
- ✕Chronic CNS disease (tumors, inflammation, seizure disorder, vascular disorder, neuromuscular disorders), or persistent neurological symptoms from serious head injury
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Dose-Optimized, Open-Label, Safety/Tolerability and Pharmacokinetic Study With Azstarys® in Children 4 and 5 Years of Age With Attention-Deficit/Hyperactivity Disorder
In Brief
A Phase 4 clinical trial evaluating Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH) for Attention Deficit/Hyperactivity Disorder. Completed, enrolled 123 participants across 20 sites.
Detailed Summary
The is a multicenter, dose-optimized, open-label, safety/ tolerability and pharmacokinetic (PK) study with Azstarys® in children 4 and 5 years of age with attention-deficit/hyperactivity disorder (ADHD). The primary objective is to determine the safety and tolerability of treating children 4 and 5 years-of-age with ADHD with Azstarys® for up 12 months. Approximately 100 subjects will be enrolled. Approximately 20 sites will participate.
Study Details
Timeline
Interventions
Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)