EB-1020 (centanafadine) for ADHD in children and adolescents
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
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 |
| Enrollment | 315 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | Otsuka Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Sapporo) |
| Trial ID | NCT07086313 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Non-stimulant ADHD medications have demonstrated efficacy, and centanafadine has been studied in adults, but pediatric data for centanafadine are limited.
Eligibility criteria
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 this trial is running
Sapporo
- Hokkaido University Hospital — Sapporo, Japan (Recruiting)
Study contacts
- Study coordinator: Drug Information Center
- Phone: +81-3-6361-7314
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.