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

NCT ID: NCT07087327

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-16
• Study Completion Date: 2027-08-31

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)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EB-1020 (QD XR Capsules) low dose

Group Type: EXPERIMENTAL

EB-1020 (Centanafadine) low dose

Intervention Type: DRUG

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

EB-1020 (QD XR Capsules) high dose

Group Type: EXPERIMENTAL

EB-1020 (Centanafadine) high dose

Intervention Type: DRUG

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

Interventions

EB-1020 (Centanafadine) low dose

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

Intervention Type: DRUG

EB-1020 (Centanafadine) high dose

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

<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.

Exclusion Criteria

<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
• 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.

• Active suicidal ideation as evidenced by an answer of "yes" on Questions 4 or 5 (over the last 6 months) on the section of suicidal ideation or a history of suicidal behavior (over the last 6 months) on the Baseline/Screening version of the C-SSRS at screening.
• Participants with a diagnosis of substance use disorder.
• Participants who have laboratory test results at screening as follows:

• Platelets<=130,000/mm3
• Hemoglobin<=11.2 g/dL
• Neutrophils, absolute<=1000/mm3
• AST > 2 x ULN
• ALT > 2 x ULN
• eGFR < 45 mL/min/1.73 m2, calculated by the CKiD U25 equation
• CPK>=2 x ULN (except for the participants that the medical monitor determines that inclusion is possible based on discussion about their condition with the investigator or subinvestigator)
• Abnormal values for both free T4 and TSH
• Participants who cannot agree to discontinuation of prohibited concomitant medication, such as ADHD medication or antidepressants.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nobuhito Sanada

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Co., Ltd.

Locations

Hokkaido University Hospital

Sapporo, , Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Drug Information Center

Role: CONTACT

Phone: +81-3-6361-7314

Other Identifiers

405-102-00115

Identifier Type: -

Identifier Source: org_study_id