EB-1020 (centanafadine) for ADHD in children and adolescents
Official title: A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled, Japan-China Joint Trial to Evaluate the Efficacy and Safety of Two Dose Levels of EB-1020 QD XR Capsules Administered Orally Once Daily in Children and Adolescents With Attention-deficit/Hyperactivity Disorder
Run by Otsuka Pharmaceutical Co., Ltd. · NCT07086313 · Data updated 2026-11-12
This study tests two once-daily doses of EB-1020 (centanafadine) against placebo to see if it reduces ADHD symptoms and is safe for children and adolescents.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Enrollment | 315 (estimated) |
| Sponsor | Otsuka Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Sapporo) |
| Status | Recruiting |
| Started | September 3, 2025 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | December 23, 2025 |
| Trial ID | NCT07086313 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children and adolescents with a primary DSM-5 diagnosis of ADHD who meet the ADHD-RS-5 and CGI-S-ADHD score thresholds (including those already on medication and those not currently treated) are the intended participants.
✕Probably not a fit
Participants with excluded psychiatric comorbidities (such as bipolar disorder, psychotic disorder, PTSD, Tourette's disorder, panic disorder, or conduct disorder), pregnant individuals, or those with symptom scores below the trial thresholds are unlikely to benefit from or be eligible for this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, double-blind Phase 2/3 trial compares two oral once-daily extended-release doses of EB-1020 (centanafadine) with placebo in pediatric patients diagnosed with ADHD. Eligible participants must meet DSM-5 criteria and prespecified symptom thresholds on the ADHD-RS-5 and CGI-S-ADHD at screening and baseline. The study tracks changes in ADHD symptom scores as the primary efficacy measure and collects safety and tolerability data throughout treatment. All study visits and assessments are conducted at the listed study site with routine monitoring for adverse events.
Why it matters
Potential benefit: If successful, EB-1020 could offer an additional once-daily medication option to help reduce ADHD symptoms in children and adolescents.
How similar studies have gone: Non-stimulant ADHD medications have demonstrated efficacy, and centanafadine has been studied in adults, but pediatric data for centanafadine are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 Columbia-Suicide Severity Rating Scale (C-SSRS) at screening. * Participants with a diagnosis of substance use disorder. * 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 cases that the medical monitor determined that participant's inclusion is possible based on the discussion about the participant's 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 it's running
-
Hokkaido University Hospital
Sapporo, Japan Recruiting
Study contacts
- Study coordinator: Drug Information Center
- Phone: +81-3-6361-7314
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.