A Phase 3 Study of Viloxazine ER Capsules in Korean Children and Adolescents With ADHD

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter bridging clinical trial designed to evaluate the efficacy and safety of viloxazine extended-release capsules (AK-D101) compared with placebo in Korean children and adolescents aged 6 to 17 years with attention-deficit/hyperactivity disorder (ADHD). Eligible participants will be randomized in a 1:1 ratio to receive AK-D101 or placebo once daily for 8 weeks. Randomization will be stratified by study site and age group (children aged 6 to 11 years and adolescents aged 12 to 17 years). The primary efficacy endpoint is the change from baseline to Week 8, End of Treatment, in the Korean ADHD Rating Scale, 5th Edition (K-ARS-5) Total Score.

NCT Number	NCT07678827
Lead Sponsor	Alvogen Korea
Conditions	Attention Deficit Hyperactivity Disorder, Attention-Deficit / Hyperactivity Disorder, ADHD
Enrollment	156 participants
Start Date	2026-07
Primary Completion	2027-09 (estimated)
Study Completion	2027-09 (estimated)
Updated on ClinicalTrials.gov	2026-07-02