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
Sponsor study identifier
interventional
315
1 country
1
Study Start
September 3, 2025
Actual (reported)Primary Completion
August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 17, 2025
Actual (reported)July 25, 2025
Actual (reported)September 3, 2025
Actual (reported)August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change from baseline in ADHD-RS-5 symptom total raw score at Week 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.
Baseline, Weeks 6
low dose, capsule, oral, once daily, for 6 weeks
high dose, capsule, oral, once daily, for 6 weeks
Hokkaido University Hospital
Sapporo, Japan
Nobuhito Sanada
Otsuka Pharmaceutical Co., Ltd.
First Submitted
July 17, 2025
First Posted
July 25, 2025
Study Start
September 3, 2025
Actual (reported)Primary Completion
August 2027
EstimatedA Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Centanafadine Capsules in Pediatric Subjects With Attention-deficit Hyperactivity Disorder
Placebo, capsule, oral, once daily, for 6 weeks
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 23, 2025
Record last verified: 2025-12
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
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Source: ClinicalTrials.gov.
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