A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHD
ID: NCT07086313
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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.
low dose, capsule, oral, once daily, for 6 weeks
high dose, capsule, oral, once daily, for 6 weeks
Placebo, capsule, oral, once daily, for 6 weeks
Treatment Arms Description
- 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.
- Abnormal values for both free T4 and TSH
- Participants who cannot agree to discontinuation of prohibited concomitant medication, such as ADHD medication or antidepressants.
- 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
Primary Outcome Measures
- Change from baseline in ADHD-RS-5 symptom total raw score at Week 6. — Time Frame: Baseline, Weeks 6
The ADHD-RS-5 is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (never to rarely/no problem) to 3 (very often/severe problem). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms). Negative change from Baseline indicates improvement. Mixed-effect model repeated measure (MMRM) was used for analysis.
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 1 Facilities & Contact Sites
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View Official Medical/Scientific 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