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

NCT07087327 Phase 3 RECRUITING

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.

Details

Lead sponsor	Otsuka Pharmaceutical Co., Ltd.
Phase	Phase 3
Status	RECRUITING
Enrolment	180
Start date	2025-09-16
Completion	2027-08

Conditions

• Attention-Deficit Hyperactivity Disorder(ADHD)

Interventions

• EB-1020 (Centanafadine) low dose
• EB-1020 (Centanafadine) high dose

Primary outcomes

• Number of Patients Experiencing Treatment-Emergent Adverse Events (TEAEs) — Baseline, week52
  An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with an onset date on or after the first dose of IMP. They are all adverse events that started after the start of centanafadine; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interruption or reduction of study therapy.

Countries

Japan