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Recruiting NCT07086313

A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHD

Phase II / Phase III Interventional Attention-Deficit Hyperactivity Disorder(ADHD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EB-1020 (Centanafadine) low dose, EB-1020 (Centanafadine) high dose, Placebo.
Who it may be relevant to
Registry conditions: Attention-Deficit Hyperactivity Disorder(ADHD). Basic parameters: 6 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

The purpose of this study is to evaluate the efficacy and examine the safety of two doses of EB-1020 QD XR capsule administered once daily orally in pediatric ADHD patients.

Interventions

  • Drug EB-1020 (Centanafadine) low dose
    low dose, capsule, oral, once daily, for 6 weeks
  • Drug EB-1020 (Centanafadine) high dose
    high dose, capsule, oral, once daily, for 6 weeks
  • Drug Placebo
    Placebo, capsule, oral, once daily, for 6 weeks

Primary outcome measures

  • Change from baseline in ADHD-RS-5 symptom total raw score at Week 6. [Time frame: Baseline, Weeks 6]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Japan · 1 center
  • Hokkaido University Hospital — Sapporo

Identifiers

NCT: NCT07086313 · 405-102-00114

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗