A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHD

ConditionAttention-Deficit Hyperactivity Disorder(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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

EB-1020 (Centanafadine) low dose
Drug
low dose, capsule, oral, once daily, for 6 weeks
EB-1020 (Centanafadine) high dose
Drug
high dose, capsule, oral, once daily, for 6 weeks
Placebo
Drug
Placebo, capsule, oral, once daily, for 6 weeks

Treatment groups

315 Participants

are divided into 3 treatment groups

Group A: EB-1020(QD XR capsules) low doseExperimental treatment 1 intervention

Group B: EB-1020(QD XR capsules) high doseExperimental treatment 1 intervention

Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Change from baseline in ADHD-RS-5 symptom total raw score at Week 6.

The ADHD-RS-5 is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (never to rarely/no problem) to 3 (very often/severe problem). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms). Negative change from Baseline indicates improvement. Mixed-effect model repeated measure (MMRM) was used for analysis.

Time frame

Baseline, Weeks 6

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Otsuka Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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