Trials / Recruiting
RecruitingNCT07087327
A Long-term Trial of EB-1020 in Pediatric Patients With ADHD
A Phase 3, Multicenter, Open-label, Uncontrolled, Long-term Japan-China Joint Trial to Evaluate the Safety and Efficacy of EB-1020 QD XR Capsules Administered Orally Once Daily in Children and Adolescents 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
- 6 Years – 17 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 pediatric ADHD patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EB-1020 (Centanafadine) low dose | low dose, capsule, oral, once daily, for 52 weeks |
| DRUG | EB-1020 (Centanafadine) high dose | high dose, capsule, oral, once daily, for 52 weeks |
Timeline
- Start date
- 2025-09-16
- Primary completion
- 2027-08-01
- Completion
- 2027-08-01
- First posted
- 2025-07-28
- Last updated
- 2025-12-23
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT07087327. Inclusion in this directory is not an endorsement.