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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
low dose, capsule, oral, once daily, for 52 weeks
high dose, capsule, oral, once daily, for 52 weeks
Hokkaido University Hospital
Sapporo, Japan
RECRUITINGNumber 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, week52
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