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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

<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.

Критерии исключения

<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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Япония · 1 центр

• Hokkaido University Hospital — Sapporo

Идентификаторы

NCT: NCT07087327 · 405-102-00115

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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