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Clinical Trial Summary

The primary purpose of this trial is to evaluate the safety and tolerability of centanafadine QD XR in pediatric subjects with ADHD.


Clinical Trial Description

This open-label study will assess the overall safety and tolerability of centanafadine once daily extended-release capsules in pediatric subjects (ages 4-17). The study will accept rollover subjects from double-blind parent trials and individuals that did not participate in one of the double-blind parent trials, may enroll as De Novo subjects after meeting all required study entry criteria. All subjects will complete a minimum of 52 weeks and may continue until the last subject enrolled reaches 52 weeks of study treatment. ;


Study Design


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit/Hyperactivity Disorder
  • Hyperkinesis

NCT number NCT05279313
Study type Interventional
Source Otsuka Pharmaceutical Development & Commercialization, Inc.
Contact Otsuka Call Center
Phone 844-687-8522
Email OtsukaRMReconciliation@rmpdc.org
Status Recruiting
Phase Phase 3
Start date February 24, 2022
Completion date November 27, 2024

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