Long-term EB-1020 treatment for children with ADHD

A Phase 3, Multicenter, Open-label, Uncontrolled, Long-term Japan-China Joint Trial to Evaluate the Safety and Efficacy of EB-1020 QD XR Capsules Administered Orally Once Daily in Children and Adolescents With Attention- Deficit/Hyperactivity Disorder

This trial will test whether giving children with ADHD mainly high doses of EB-1020 for 52 weeks is safe.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 6 Years to 17 Years
• Sex: All
• Sponsor: Otsuka Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Sapporo)
• Trial ID: NCT07087327 on ClinicalTrials.gov

What this trial studies

This Phase 3, open-label long-term treatment program gives pediatric participants either low or mainly high doses of EB-1020 (centanafadine) for up to 52 weeks, enrolling both rollover participants from a preceding double-blind parent trial and new participants who meet DSM-5 ADHD criteria. The primary focus is on safety and tolerability, with regular monitoring for adverse events, vital signs, and laboratory measures across the treatment period. Eligible new participants must meet severity thresholds on ADHD-RS-5 and CGI-S-ADHD at baseline, while rollover participants must have completed the parent trial without major protocol problems. The protocol is conducted at Hokkaido University Hospital and emphasizes long-term safety data collection rather than efficacy as the primary objective.

Who should consider this trial

Good fit: Ideal candidates are pediatric patients with DSM-5 ADHD who either completed the preceding double-blind parent trial or are treatment-naïve entrants with ADHD-RS-5 scores ≥28 and a CGI-S-ADHD score of ≥4 at baseline.

Not a fit: Patients who are pregnant, who had major compliance or safety problems in the parent trial, or who do not meet the specified severity thresholds are unlikely to benefit from participating in this long-term safety program.

Why it matters

Potential benefit: If successful, this could show that long-term EB-1020 is safe in children and provide clinicians with an additional medication option for pediatric ADHD.

How similar studies have performed: Shorter double-blind trials of EB-1020 have been conducted and shown some symptomatic benefit, but robust long-term pediatric safety data are still limited.

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.

Where this trial is running

Sapporo

• Hokkaido University Hospital — Sapporo, Japan (Recruiting)

Study contacts

• Study coordinator: Drug Information Center

Conditions Attention-Deficit Hyperactivity Disorder