A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHD
NCT ID: NCT07086313
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
315 participants
INTERVENTIONAL
2025-09-03
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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EB-1020(QD XR capsules) low dose
EB-1020 (Centanafadine) low dose
low dose, capsule, oral, once daily, for 6 weeks
EB-1020(QD XR capsules) high dose
EB-1020 (Centanafadine) high dose
high dose, capsule, oral, once daily, for 6 weeks
Placebo
Placebo
Placebo, capsule, oral, once daily, for 6 weeks
Interventions
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EB-1020 (Centanafadine) low dose
low dose, capsule, oral, once daily, for 6 weeks
EB-1020 (Centanafadine) high dose
high dose, capsule, oral, once daily, for 6 weeks
Placebo
Placebo, capsule, oral, once daily, for 6 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 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.
6 Years
17 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Nobuhito Sanada
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Co., Ltd.
Locations
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Hokkaido University Hospital
Sapporo, , Japan
Countries
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Central Contacts
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Drug Information Center
Role: CONTACT
Phone: +81-3-6361-7314
Other Identifiers
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405-102-00114
Identifier Type: -
Identifier Source: org_study_id