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

NCT07086313 | Recruiting Phase 2

• 1 other identifier: 405-102-00114
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Attention-Deficit Hyperactivity Disorder(ADHD)

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Weeks 6

Study Arms (3)

EB-1020(QD XR capsules) low dose

EXPERIMENTAL

Drug: EB-1020 (Centanafadine) low dose

EB-1020(QD XR capsules) high dose

EXPERIMENTAL

Drug: EB-1020 (Centanafadine) high dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

EB-1020 (Centanafadine) high dose DRUG

high dose, capsule, oral, once daily, for 6 weeks

EB-1020(QD XR capsules) high dose

EB-1020 (Centanafadine) low dose DRUG

low dose, capsule, oral, once daily, for 6 weeks

EB-1020(QD XR capsules) low dose

Placebo DRUG

Placebo, capsule, oral, once daily, for 6 weeks

Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Conduct disorder
• Psychotic disorder
• Post-traumatic stress disorder
• Bipolar disorder
• Participants with a generalized anxiety disorder requiring pharmacotherapy, based on the DSM-5 diagnostic criteria.
• Participants with an autism spectrum disorder based on the DSM-5 diagnostic criteria.
• Participants with a personality disorder, oppositional defiant disorder, or obsessive-compulsive disorder that is the primary focus of treatment, based on the DSM-5 diagnostic criteria.
• Participants with a diagnosis of major depressive disorder (MDD), based on the DSM-5 diagnostic criteria who currently have a major depressive episode, or who have required treatment for MDD within the past 3 months prior to screening.
• Also, participants who, in the judgment of the investigator or subinvestigator, may have a worsening of MDD during the trial or may require treatment during the trial period.
• Participants who have a diagnosis of intellectual disability with an intelligence quotient (IQ) score less than 70.
• Participants who have a significant risk of committing suicide in the opinion of the investigator or subinvestigator, or based on the following evidence.

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Hokkaido University Hospital

Sapporo, Japan

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

1-(naphthalen-2-yl)-3-azabicyclo(3.1.0)hexane

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Nobuhito Sanada

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Drug Information Center

CONTACT

+81-3-6361-7314

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 25, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

Locations

JP (1)