A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHD
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age6-17
SponsorOtsuka Pharmaceutical Co., Ltd.
About this trial
The purpose of this study is to evaluate the efficacy and examine the safety of two doses of EB-1020 QD XR capsule administered once daily orally in pediatric ADHD patients.
Eligibility criteria
Qualifiers
Participants with a primary diagnosis of ADHD based on DSM-5 diagnostic criteria, differentiated from other mental disorders using the MINI-KID, excluding other specified ADHD or unspecified ADHD.
Participants with a symptom total raw score of>=28 (if not receiving any pharmacological treatment for ADHD) or>=22 (if receiving pharmacological treatment for ADHD) on the ADHD Rating Scale Version 5 (ADHD-RS-5) at screening.
Participants with a symptom total raw score of>=28 on the ADHD-RS-5 at baseline.
Participants with a score of 4 or higher on the Clinical Global Impression Severity - ADHD (CGI-S-ADHD) at baseline.
Disqualifiers
Participants who have a positive pregnancy test result at baseline.
Participants determined to have the following diseases based on an interview using the MINI-KID.
Tourette's disorder
Panic disorder
Trial design
Treatments tested in this trial
- EB-1020 (Centanafadine) low dose
- EB-1020 (Centanafadine) high dose
- Placebo
Treatment groups
315 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov