A Long-term Trial of EB-1020 in Pediatric Patients With ADHD

NCT07087327 | Recruiting Phase 3

• 1 other identifier: 405-102-00115
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Attention-Deficit Hyperactivity Disorder(ADHD)

Outcome Measures

Primary Outcomes (1)

• Number of Patients Experiencing Treatment-Emergent Adverse Events (TEAEs)

  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.

  Baseline, week52

Study Arms (2)

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

Interventions

EB-1020 (Centanafadine) low dose DRUG

low dose, capsule, oral, once daily, for 52 weeks

EB-1020 (QD XR Capsules) low dose

EB-1020 (Centanafadine) high dose DRUG

high dose, capsule, oral, once daily, for 52 weeks

EB-1020 (QD XR Capsules) high dose

Eligibility Criteria

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

You may qualify if:

• \<Rollover participants\>
• Participants who completed the 6-week treatment period and 1-week follow-up period in the preceding double-blind parent trial and did not meet the criteria for discontinuation of the IMP at Week 6.
• Participants who have not been found to have major problems with trial requirements, such as compliance with the IMP, in the preceding double-blind parent trial.
• \<De novo participants\>
• 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 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:

• \<Rollover participants\>
• Participants who have a positive pregnancy test result at baseline.
• Participants who were found to have serious or severe adverse events that were judged to be related to the IMP in the preceding double-blind parent trial.
• Participants who have a significant risk of committing suicide in the opinion of the investigator or subinvestigator, or based on the following evidence.
• Active suicidal ideation as evidenced by an answer of "yes" on Questions 4 or 5 on the section of suicidal ideation or reported suicidal behavior on the since last visit version of the Columbia-Suicide Severity Rating Scale (C SSRS) in the preceding double-blind parent trial.
• Participants who plan to use prohibited medication during the trial. Participants who used prohibited medication during the preceding double-blind parent trial should be excluded if the investigator or subinvestigator judges that there is a possibility of repeated use of prohibited medication.
• \<De novo participants\>
• 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

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 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 28, 2025
• Study Start: September 16, 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)