NCT07086313 A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHD
| NCT ID | NCT07086313 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Otsuka Pharmaceutical Co., Ltd. |
| Condition | Attention-Deficit Hyperactivity Disorder(ADHD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 315 participants |
| Start Date | 2025-09-03 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 315 participants in total. It began in 2025-09-03 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Drug Information Center
📞 +81-3-6361-7314
Nobuhito Sanada
STUDY DIRECTOR
Otsuka Pharmaceutical Co., Ltd.
Frequently Asked Questions
Who can join the NCT07086313 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 17 Years, studying Attention-Deficit Hyperactivity Disorder(ADHD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07086313 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07086313 currently recruiting?
Yes, NCT07086313 is actively recruiting participants. Visit ClinicalTrials.gov or contact Otsuka Pharmaceutical Co., Ltd. to inquire about joining.
Where is the NCT07086313 trial being conducted?
This trial is being conducted at Sapporo, Japan.
Who is sponsoring the NCT07086313 clinical trial?
NCT07086313 is sponsored by Otsuka Pharmaceutical Co., Ltd.. The principal investigator is Nobuhito Sanada at Otsuka Pharmaceutical Co., Ltd.. The trial plans to enroll 315 participants.