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

Otsuka

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Attention-Deficit Hyperactivity Disorder(ADHD)

Treatments: Drug: Placebo; Drug: EB-1020 (Centanafadine) high dose; Drug: EB-1020 (Centanafadine) low dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT07086313

405-102-00114

Details and patient eligibility

About

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.

Enrollment: 315 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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315 participants in 3 patient groups, including a placebo group

EB-1020(QD XR capsules) low dose

Experimental group

Treatment:

Drug: EB-1020 (Centanafadine) low dose

EB-1020(QD XR capsules) high dose

Experimental group

Treatment:

Drug: EB-1020 (Centanafadine) high dose

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo