Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05685732

An Efficacy and Safety Study w/ Azstarys® in Children With ADHD — KP415P01  

Attention Deficit/Hyperactivity Disorder Clinical Trial

Official title:
A Multicenter, Dose-Optimized, Randomized, Double Blind, Efficacy and Safety Study With Azstarys® in Children 4 to 12 Years of Age With Attention Deficit/Hyperactivity Disorder

Clinical Trial Summary

This is a multicenter, dose-optimized, randomized, double-blind, efficacy and safety study with Azstarys® in children 4 to 12 years of age with attention-deficit/hyperactivity disorder (ADHD). Azstarys® contains dexmethylphenidate (d-MPH) and serdexmethylphenidate (SDX), a prodrug of d-MPH and is orally adminstered. The primary objective is to determine the efficacy of Azstarys® compared to placebo in treating children ages 4 to 12 years old with ADHD. The study will consist of two randomized and blinded treatment cohorts ages 4 to 5 years of age and 6 to 12 years of age. 130 and 100 subjects will be enrolled respectively. Approximately 20 sites will participate.

Clinical Trial Description

- Screening Period (Visit 1) Subjects will undergo a screening period up to 30 days prior to entering the Treatment Period. - Double-Blind Treatment Period (Visit 2 through Visit 6) Eligible subjects will be randomized in a blinded fashion to Azstarys® or placebo at the start of the Treatment Period. Randomization will be applied separately in each cohort and stratified by gender. - Cohort 1: Subjects 4 and 5 years (<6 years) will start at 13.1 mg/2.6 mg or matching placebo and may be titrated up or down to doses of 13.1 mg/2.6 mg, 26.1 mg/5.2 mg, or 39.2 mg/7.8 mg Azstarys® or matching placebo approximately each week through Visit 5 - Cohort 2: Subjects 6-12 years (<13 years) will start at 39.2 mg/7.8 mg or matching placebo and may be titrated up or down to doses of 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, or 52.3 mg/10.4 mg Azstarys® or matching placebo approximately each week through Visit 5 ;

Study Design

Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit/Hyperactivity Disorder
  • Hyperkinesis
Clinical Trial Details
NCT number NCT05685732
Study type Interventional
Source Corium, Inc.
Contact
Status Active, not recruiting
Phase Phase 4
Start date March 22, 2023
Completion date June 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05741307 - Effect of a Self-hypnosis on Attention Disorders and Anxiety in Children With Attention Deficit/Hyperactivity Disorder N/A
Not yet recruiting NCT06133231 - Optimizing Research With Diverse Families N/A
Completed NCT02286349 - Non Invasive Brain Stimulation Effects on Attentional Performance in ADHD Adults N/A
Completed NCT00214981 - Evaluate the Safety and Efficacy of Modafinil in Children and Adolescents With ADHD Phase 3
Active, not recruiting NCT04189536 - An SMS Intervention to Improve Adherence to Stimulant Medications in Adults With ADHD N/A
Recruiting NCT02433145 - Explore the Association Between Neuropsychological Functions and ADHD Diagnosis and Comorbid Using Longitudinal Study in Preschool Children N/A
Completed NCT01275378 - Comparative Effectiveness Research for Two Medical Home Models for Attention Deficit Hyperactivity Disorder N/A
Completed NCT02728011 - Pilot Trial Comparing Computerised Cognitive Exercises to Tetris in Adolescents With ADHD N/A
Completed NCT01263548 - To Evaluate the Safety and Metabolic Profile of Vyvanse for the Treatment of ADHD in Euthymic Adults With Bipolar I/II Disorder N/A
Active, not recruiting NCT00863499 - International Study to Predict Optimised Treatment in Attention Deficit/Hyperactivity Disorder Phase 4
Not yet recruiting NCT00945971 - Exercise Effects in Children With Attention Deficit Hyperactivity Disorder N/A
Active, not recruiting NCT04999982 - Pilot Testing PREschooler Care, Community Resources, Advocacy, Referral, Education (PRE-CARE) N/A
Completed NCT01259492 - Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD) Phase 3
Recruiting NCT05721235 - A Safety/Tolerability and PK Study With Azstarys® in Children With ADHD Phase 4
Active, not recruiting NCT04189575 - A Text Messaging (SMS) Intervention to Improve Adherence to Stimulant Medication in Adults With ADHD in the Primary Care Setting N/A
Completed NCT02558790 - L-Threonic Acid Magnesium Salt (L-TAMS) in ADHD Phase 2
Recruiting NCT02205268 - Near Infrared Spectroscopy Neurofeedback Training for ADHD N/A
Recruiting NCT00946582 - The Therapeutic Effects of Barkley's Parenting Management Program for Taiwanese School-Aged Children With Attention Deficit/Hyperactivity Disorder (ADHD) Phase 1
Completed NCT00267605 - Strongest Families (Formerly Family Help Program): Pediatric Attention Deficit/Hyperactivity Disorder Phase 2
Recruiting NCT02017483 - Explore the Association Between the Emotion Recognition and the Attention Processing Under the Emotional Stimuli in ADHD N/A