NCT03605849

A Trial Evaluating the Long-term Safety and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder

An Open-label, 52-Week, Multicenter Trial Evaluating the Long-term Safety and Tolerability of Centanafadine Sustained-Release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 662 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the long-term safety and tolerability of centanafadine sustained-release (SR) tablets, administered twice daily (BID) in the treatment of adults with attention deficit hyperactivity disorder (ADHD).

Detailed description

This open-label study assessed the overall safety and tolerability of 400 mg total daily dose centanafadine SR tablets in participants, over the course of approximately 52 weeks. This study has accepted rollover participants from both the 405-201-00013 and 405-201-00014 trials. For individuals that did not participate in one of the studies mentioned above, they will be able to enroll if they meet the inclusion criteria as outlined below.

Conditions

• Attention Deficit Disorder
• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Centanafadine SR	200mg, BID, oral tablets

Timeline

• Start date: 2019-02-14
• Primary completion: 2021-09-07
• Completion: 2021-09-07
• First posted: 2018-07-30
• Last updated: 2024-10-01
• Results posted: 2024-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study