Attention-Deficit Hyperactivity Disorder(ADHD)Phase 2/3NCT07086313
A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHD
A Phase 2/3 study testing EB-1020 (Centanafadine) low dose and EB-1020 (Centanafadine) high dose in people with Attention-Deficit Hyperactivity Disorder(ADHD), run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Attention-Deficit Hyperactivity Disorder(ADHD)
- What is being tested?
- EB-1020 (Centanafadine) low dose and EB-1020 (Centanafadine) high dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 315 participants
- Where
- 1 siteJapan
- Study dates
- 3 Sep 2025to Aug 2027
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Drug Information Center contact
About this study
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
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.
- Being tested
- EB-1020 (Centanafadine) low dose, EB-1020 (Centanafadine) high dose, Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EB-1020 (Centanafadine) low doseDrug
low dose, capsule, oral, once daily, for 6 weeks
EB-1020 (Centanafadine) high doseDrug
high dose, capsule, oral, once daily, for 6 weeks
PlaceboDrug
Placebo, capsule, oral, once daily, for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| EB-1020(QD XR capsules) low dose | Experimental | Not described Receives: Drug: EB-1020 (Centanafadine) low dose |
| EB-1020(QD XR capsules) high dose | Experimental | Not described Receives: Drug: EB-1020 (Centanafadine) high dose |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Weeks 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start3 Sep 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-Deficit Hyperactivity Disorder(ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nobuhito Sanada, Study director, Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086313
- Sponsor's protocol ID
- 405-102-00114
- Status last verified
- Dec 2025
- First submitted
- 17 Jul 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.