Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05721235

A Safety/Tolerability and PK Study With Azstarys® in Children With ADHD — KP415P02  

Attention Deficit/Hyperactivity Disorder Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

• Screening Period: New subjects will undergo a Screening Period up to 30 days prior to entering the Dose Optimization Phase. • Dose Optimization Phase: During the 3-week Dose Optimization Phase, subjects will start at 13.1 mg/2.6 mg, and may be titrated to doses of 26.1 mg/5.2 mg or 39.2 mg/7.8 mg Azstarys® capsules based on individual tolerability and best dose-response in the opinion of the Investigator. • Treatment Phase: Eligible subjects will receive single daily doses of Azstarys® for approximately 360 ±20 days (approximately 12 months). The starting dose of Azstarys® in the Treatment Phase will be the same as the optimized dose of Azstarys® at the end of the Dose Optimization Phase, either 13.1 mg/2.6 mg, 26.1/5.2 mg, or 39.2 mg/7.8 mg per day. The daily dose may be changed at any time to any of the allowed dose levels (13.1 mg/2.6 mg, 26.1/5.2 mg, or 39.2 mg/7.8 mg per day) at the Investigator' discretion, based on individual tolerability and dose response. ;

Study Design

Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit/Hyperactivity Disorder
  • Hyperkinesis
Clinical Trial Details
NCT number NCT05721235
Study type Interventional
Source Corium, Inc.
Contact Ron Tashjian
Phone 617-233-7474
Email rtashjian@corium.com
Status Recruiting
Phase Phase 4
Start date May 24, 2023
Completion date March 30, 2025
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 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
Completed NCT02728011 - Pilot Trial Comparing Computerised Cognitive Exercises to Tetris in Adolescents With ADHD N/A
Completed NCT01275378 - Comparative Effectiveness Research for Two Medical Home Models for Attention Deficit Hyperactivity 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
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
Active, not recruiting NCT05685732 - An Efficacy and Safety Study w/ Azstarys® in Children With ADHD Phase 4
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