Centanafadine for ADHD
Trial Summary
What is the purpose of this trial?
This trial aims to test the safety and tolerability of a daily ADHD medication in children and teens aged 4-17. The medication releases its effects slowly over the day to help manage symptoms consistently. HLD200 is a form of methylphenidate designed to provide benefits from morning until evening.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have started, changed, or stopped psychological treatments for ADHD in the last 30 days, you may not be eligible to participate.
What data supports the effectiveness of the drug Centanafadine Hydrochloride for ADHD?
Eligibility Criteria
This trial is for children and adolescents aged 4 to 17 with ADHD who completed a previous double-blind study. They must have an ADHD diagnosis, significant symptoms, and in some cases, inadequate response to psychotherapy. Excluded are those with certain severe psychiatric conditions or history of drug-related skin reactions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive centanafadine once daily extended-release capsules for ADHD
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants may continue treatment until all enrolled subjects in their age group reach the Week 52 visit
Treatment Details
Interventions
- Centanafadine Hydrochloride
Find a Clinic Near You
Who Is Running the Clinical Trial?
Otsuka Pharmaceutical Development & Commercialization, Inc.
Lead Sponsor
John Kraus
Otsuka Pharmaceutical Development & Commercialization, Inc.
Chief Medical Officer since 2023
MD, PhD
Tarek Rabah
Otsuka Pharmaceutical Development & Commercialization, Inc.
Chief Executive Officer since 2022
BS in Biology and BA in Business from the American University of Beirut, MBA from McGill University