A Long-term Trial of EB-1020 in Pediatric Patients With ADHD

Official title

A Phase 3, Multicenter, Open-label, Uncontrolled, Long-term Japan-China Joint Trial to Evaluate the Safety and Efficacy of EB-1020 QD XR Capsules Administered Orally Once Daily in Children and Adolescents With Attention- Deficit/Hyperactivity Disorder

Overview

The purpose of this study is to evaluate the safety of long-term administration of mainly high doses of EB-1020 over 52 weeks in pediatric ADHD patients.

Interventions

• Drug EB-1020 (Centanafadine) low dose
  low dose, capsule, oral, once daily, for 52 weeks
• Drug EB-1020 (Centanafadine) high dose
  high dose, capsule, oral, once daily, for 52 weeks

Primary outcome measures

• Number of Patients Experiencing Treatment-Emergent Adverse Events (TEAEs) [Time frame: Baseline, week52]

Eligibility criteria

Inclusion criteria

<Rollover participants>

• Participants who completed the 6-week treatment period and 1-week follow-up period in the preceding double-blind parent trial and did not meet the criteria for discontinuation of the IMP at Week 6.
• Participants who have not been found to have major problems with trial requirements, such as compliance with the IMP, in the preceding double-blind parent trial.

<De novo participants>

• 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 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

<Rollover participants>

• Participants who have a positive pregnancy test result at baseline.
• Participants who were found to have serious or severe adverse events that were judged to be related to the IMP in the preceding double-blind parent trial.
• 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 on the section of suicidal ideation or reported suicidal behavior on the since last visit version of the Columbia-Suicide Severity Rating Scale (C SSRS) in the preceding double-blind parent trial.
• Participants who plan to use prohibited medication during the trial. Participants who used prohibited medication during the preceding double-blind parent trial should be excluded if the investigator or subinvestigator judges that there is a possibility of repeated use of prohibited medication.

<De novo participants>

• 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 C-SSRS at screening.
• Participants with a diagnosis of substance use disorder.
• Participants who have laboratory test results at screening as follows:

• 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 participants that the medical monitor determines that inclusion is possible based on discussion about their 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Japan · 1 center

• Hokkaido University Hospital — Sapporo

Identifiers

NCT: NCT07087327 · 405-102-00115

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗