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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
315
low dose, capsule, oral, once daily, for 6 weeks
high dose, capsule, oral, once daily, for 6 weeks
Placebo, capsule, oral, once daily, for 6 weeks
Hokkaido University Hospital
Sapporo, Japan
RECRUITINGChange from baseline in ADHD-RS-5 symptom total raw score at Week 6.
The ADHD-RS-5 is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (never to rarely/no problem) to 3 (very often/severe problem). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms). Negative change from Baseline indicates improvement. Mixed-effect model repeated measure (MMRM) was used for analysis.
Time frame: Baseline, Weeks 6
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