A Phase 3 Study of Viloxazine ER Capsules in Korean Children and Adolescents With ADHD (NCT07678827) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Phase 3 Study of Viloxazine ER Capsules in Korean Children and Adolescents With ADHD
South Korea156 participantsStarted 2026-07
Plain-language summary
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.
Who can participate
Age range
6 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Korean male or female subjects who are ≥6 and ≤17 years of age at the time of written informed consent.
. Subjects with a primary diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), confirmed by the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) at Visit 1 (Screening).
. Subjects with a Korean ADHD Rating Scale, 5th Edition (K-ARS-5) Total Score of ≥28 at Visit 1 (Screening) and Visit 2 (Baseline).
. Subjects with a Clinical Global Impression-Severity (CGI-S) score of ≥4 at Visit 1 (Screening) and Visit 2 (Baseline).
. Subjects who meet the following body weight criteria at Visit 1 (Screening):
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline to Week 8 in K-ARS-5 (Korean ADHD Rating Scale, 5th Edition) Total Score
. Subjects considered suitable for participation in the clinical trial by the investigator based on clinical laboratory tests, vital signs, and ECG assessments, meeting all of the following criteria:
. Subjects whose legally authorized representative(s), or parent(s), and the subject, as applicable, voluntarily agree to participate in this clinical trial and provide written informed consent/assent.
. Subjects who are currently taking viloxazine, who previously took viloxazine for the treatment of ADHD but discontinued it due to adverse reactions or lack of efficacy, or who have a history of allergic reaction, hypersensitivity\*, or intolerance to viloxazine extended-release capsules or any of their excipients.
. Subjects who, at Screening according to the MINI-KID, are diagnosed with a psychiatric disorder other than ADHD as the primary diagnosis, or who have a comorbid psychiatric disorder secondary to ADHD that, in the opinion of the investigator, may interfere with treatment adherence to the investigational medicinal product or affect study results. However, subjects with a history of Major Depressive Disorder may be eligible if no episode has occurred within 6 months prior to the Screening visit.
. Subjects with a history of diagnosis of significant central nervous system (CNS) disease or neuromuscular disease, including:
. Subjects with a history of diagnosis of medically significant systemic disease.
. Subjects with a history of suicidal plan/intent, suicidal ideation, or one or more suicide attempts within 6 months prior to the Screening visit.
. Subjects whose BMI exceeds the 95th percentile for age and sex at the Screening visit.