A Safety/Tolerability and PK Study With Azstarys® in Children With ADHD

NCT05721235 | Completed Phase 4 FDA Drug

• 1 other identifier: KP415.P02
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Attention Deficit/Hyperactivity Disorder

Keywords

ADHD; Azstarys; Serdexmethylphenidate; Attention Deficit Hyperactvity Disorder

Outcome Measures

Primary Outcomes (1)

• A determination of safety and tolerability of up to 12 months of treatment with Azstarys

  Safety and tolerability will be assessed by the incidence of adverse events reported in the study

  12 months

Study Arms (1)

Open Label

EXPERIMENTAL

13.1 mg/2.6 mg SDX/d-MPH, 26.1/5.2 mg SDX/d-MPH, or 39.2 mg/7.8 mg SDX/d-MPH

Drug: Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)

Interventions

Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH) DRUG

Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)

Open Label

Eligibility Criteria

• Age: 4 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• New Subjects must be at least 4 years old and less than 5 years and 10 months old at Screening.
• Subjects must have a body weight within the 5th and 95th percentile according to the gender-specific weight-for-age percentile charts from the Centers for Disease Control and Prevention (CDC).
• Subject must be in general good health defined as the absence of any clinically relevant abnormalities as determined by the Investigator based on physical examinations, vital signs, ECGs, medical history, and clinical laboratory values (chemistry, hematology and urinalysis) at Screening.
• At least one parent/legal guardian of the subject must voluntarily give written permission for the subject to participate in the study.
• Subject must meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for a primary diagnosis of ADHD (combined, inattentive, or hyperactive/impulsive presentation) per clinical evaluation and confirmed by the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid).
• Subject must have had ADHD symptoms present for at least 6 months prior to the Screening Visit.
• Subject must be able and willing to wash out current stimulant ADHD medications, including herbal medications from 5 days prior to the start of the Dose Optimization Phase, and abstain from taking these to the end of the Treatment Phase (Visit 17) or Early Termination (ET); and wash out non-stimulant ADHD medications from 14 days prior to the start of the Dose Optimization Phase, and abstain from taking these to the end of the Treatment Phase (Visit 17) or ET.
• Subject must have a score of ≥4 (Moderately Ill) on the clinician-administered Clinical Global Impressions-Severity (CGI-S) scale.
• Subject functions at an age-appropriate level intellectually, as determined by the Investigator.
• Subject must have age and sex adjusted ratings of ≥90th percentile Total Score on the ADHD-RS-IV (Preschool Version) rated over the past 6 months.
• Subject must have a systolic and diastolic blood pressure below the 95th percentile for age, and gender according to the 2017 AAP guidelines (Flynn 2017) based on the average of 3 measurements 2-5 minutes apart.
• Subject's parent/legal guardian and caregiver (if applicable) must understand and be willing and able to comply with all study procedures and visit schedule.
• Subject's parent/legal guardian, and caregiver (if applicable) must be able to speak and understand English or Spanish and be able to communicate satisfactorily with the Investigator and study coordinator.

You may not qualify if:

• Subject with any clinically significant chronic medical condition that, in the judgment of the Investigator, may interfere with the participant's ability to participate in the study.
• Subject has any diagnosis of bipolar I or II disorder, major depressive disorder, conduct disorder, obsessive-compulsive disorder, any history of psychosis, autism spectrum disorder, disruptive mood dysregulation disorder (DMDD), intellectual disability, Tourette's Syndrome, confirmed genetic disorder with cognitive and/or behavioral disturbances.
• Subject has generalized anxiety disorder or panic disorder that has been the primary focus of treatment at any time during the 12 months prior to Screening, or that has required pharmacotherapy any time during the 6 months prior to Screening.
• Subject has evidence of any chronic disease of the central nervous system (CNS) such as tumors, inflammation, seizure disorder, vascular disorder, potential CNS related disorders that might occur in childhood (e.g., Duchenne Muscular dystrophy, myasthenia gravis, or other neurologic or serious neuromuscular disorders), or history of persistent neurological symptoms attributable to serious head injury.
• Subject taking anticonvulsants for seizure control currently or within the past 2 years before Screening are not eligible for study participation.
• Subject has a current (last month) psychiatric diagnosis other than specific phobia, motor skills disorders, ODD, sleep disorders, elimination disorders, adjustment disorders, learning disorders, or communication disorders.
• In the opinion of the Investigator, subject has clinically significant suicidal ideation/behavior, based on history of attempted suicide and the C-SSRS assessment at Screening.
• Subject has any clinically significant unstable medical abnormality, chronic disease (including asthma or diabetes), or a history of a clinically significant abnormality of the cardiovascular (including cardiomyopathy, serious arrhythmias, structural cardiac disorders, or severe hypertension), gastrointestinal, respiratory, hepatic, or renal systems, or a disorder or history of a condition (e.g., malabsorption, gastrointestinal surgery) that may interfere with drug absorption, distribution, metabolism, or excretion of study drug.
• Subject has a history or presence of abnormal ECGs, which in the Investigator's opinion is clinically significant.
• Subject has a history of, or currently has a malignancy.
• Subject has uncontrolled thyroid disorder as evidenced by thyroid stimulating hormone (TSH) ≤0.8 x the lower limit of normal (LLN) or ≥1.25 x the upper limit of normal (ULN) for the reference laboratory at Screening.
• Subject has greater than trace proteinuria on the urinalysis at Screening.
• A current or recent (past 12 months) history of drug abuse in someone living in the subjects' home.
• Subject has a positive urine screen for drugs of abuse at Screening. If the urine test is positive for any of the analytes at Screening, the subject will be excluded from study participation, with the exception of the following: Depending on a subject's current ADHD medication at Screening, the urine screen may test positive for MPH for treatment of their ADHD.
• Subject has participated in any other clinical study with an investigational drug/product within 30 days or at least 5 half-lives, whichever is longer, prior to Screening, except for participation in Study KP415.P01.

Sponsors & Collaborators

• Corium, Inc.: lead
• Premier Research: collaborator
• Prometrika, LLC: collaborator
• Almac: collaborator
• Worldwide Clinical Trials: collaborator

Study Sites (20)

Preferred Research Partners (PRP)

Little Rock, Arkansas, 72211, United States

Location

Advanced Research Center (ARC)

Anaheim, California, 92805, United States

Location

IMMUNOe International Research Center

Centennial, Colorado, 80112, United States

Location

Clinical Neuroscience Solutions - Orlando

Jacksonville, Florida, 32256, United States

Location

Accel Research Sites - Lakeland

Lakeland, Florida, 33803, United States

Location

Accel Research Sites - Maitland

Maitland, Florida, 32751, United States

Location

South Florida Research Phase I-IV INC

Miami Springs, Florida, 33166, United States

Location

CNS Healthcare - Orlando

Orlando, Florida, 32801, United States

Location

iResearch Atlanta

Decatur, Georgia, 30030, United States

Location

CenExel iResearch, LLC

Savannah, Georgia, 31405, United States

Location

Sky Clinical Research Network Group P.C.

Union City, Georgia, 30291, United States

Location

DelRicht Research - Touro Medical Center

New Orleans, Louisiana, 70115, United States

Location

St Charles Psychiatric Associates & Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Boeson Research

Missoula, Montana, 59804, United States

Location

Alivation Research, LLC

Lincoln, Nebraska, 68526, United States

Location

Center For Psychiatry and Behavioral Medicine Inc

Las Vegas, Nevada, 89128, United States

Location

Clinical Neuroscience Solution, Inc

Memphis, Tennessee, 38119, United States

Location

Houston Clinical Trials

Bellaire, Texas, 77401, United States

Location

AIM Trials

Plano, Texas, 75093, United States

Location

Flourish Research

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Dexmethylphenidate Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Methylphenidate; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ann Childress, MD

  Center for Psychiatry And Behavioral Medicine Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The primary objective is to determine the safety and tolerability for up to 12 months of treatment with Azstarys based on incidence of adverse events

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 9, 2023
• Study Start: June 2, 2023
• Primary Completion: August 29, 2025
• Study Completion: August 29, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)