NCT06926829

A Long-term Trial of EB-1020 in Adult Patients With ADHD

A Phase 3, Multicenter, Open-label, Uncontrolled, Long-term Trial to Evaluate the Safety and Efficacy of Long-term Administration of EB-1020 Once Daily QD XR Capsules in Adults With Attention-deficit/Hyperactivity Disorder

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety of long-term administration of mainly high doses of EB-1020 over 52 weeks in patients who have completed the double-blind trial (405-102-00112) conducted in Japan

Conditions

• Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
DRUG	EB-1020 (Centanafadine) 164.4 mg	164.4 mg, capsule, oral, once daily, for 52 weeks
DRUG	EB-1020 (Centanafadine) 328.8 mg	328.8 mg, capsule, oral, once daily, for 52 weeks

Timeline

• Start date: 2025-06-25
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-04-15
• Last updated: 2025-08-03

Locations

1 site across 1 country: Japan