A Long-term Trial of EB-1020 in Pediatric Patients With ADHD
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-17
SponsorOtsuka Pharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
EB-1020 (Centanafadine) low dose
Druglow dose, capsule, oral, once daily, for 52 weeks
EB-1020 (Centanafadine) high dose
Drughigh dose, capsule, oral, once daily, for 52 weeks
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: EB-1020 (QD XR Capsules) low doseExperimental treatment 1 intervention
Group B: EB-1020 (QD XR Capsules) high doseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Patients Experiencing Treatment-Emergent Adverse Events (TEAEs)
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with an onset date on or after the first dose of IMP. They are all adverse events that started after the start of centanafadine; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interruption or reduction of study therapy.
Time frame
Baseline, week52Sponsors and contacts
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Source ClinicalTrials.gov