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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
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
Details
| Lead sponsor | Otsuka Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | RECRUITING |
| Enrolment | 180 |
| Start date | 2025-06-25 |
| Completion | 2027-12 |
Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
Interventions
- EB-1020 (Centanafadine) 164.4 mg
- EB-1020 (Centanafadine) 328.8 mg
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