A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHD

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 otherspecified ADHD or unspecified ADHD.

• Participants with a symptom total raw score of>=28 (if not receiving anypharmacological treatment for ADHD) or>=22 (if receiving pharmacological treatmentfor 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 usingthe 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 onthe DSM-5 diagnostic criteria.

• Participants with an autism spectrum disorder based on the DSM-5 diagnosticcriteria.

• Participants with a personality disorder, oppositional defiant disorder, orobsessive-compulsive disorder that is the primary focus of treatment, based on theDSM-5 diagnostic criteria.

• Participants with a diagnosis of major depressive disorder (MDD), based on the DSM-5diagnostic criteria who currently have a major depressive episode, or who haverequired 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 intelligencequotient (IQ) score less than 70.

• Participants who have a significant risk of committing suicide in the opinion of theinvestigator 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 ofsuicidal behavior (over the last 6 months) on the Baseline/Screening version ofthe 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 thatparticipant's inclusion is possible based on the discussion about theparticipant's condition with the investigator or subinvestigator)

• Abnormal values for both free T4 and TSH

• Participants who cannot agree to discontinuation of prohibited concomitantmedication, such as ADHD medication or antidepressants.