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

NCT07678827 | Not Yet Recruiting Phase 3

• 2 other identifiers: AK-CTD101-III-01103363
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention-Deficit / Hyperactivity Disorder; ADHD; Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Attention-Deficit/Hyperactivity Disorder; Viloxazine; Viloxazine Extended-Release; Viloxazine ER; AK-D101; Qelbree; Korean Population; Bridging Study; Pediatric ADHD; Adolescent ADHD

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 8 in K-ARS-5 (Korean ADHD Rating Scale, 5th Edition) Total Score

  The Korean ADHD Rating Scale, 5th Edition (K-ARS-5) Total Score is used to assess ADHD symptoms. The total score ranges from 0 to 54, with higher scores indicating more severe ADHD symptoms. A negative change from baseline indicates improvement.

  Baseline to Week 8, End of Treatment

Secondary Outcomes (4)

• Change From Baseline in the Korean ADHD Rating Scale, 5th Edition Total Score at Each Scheduled Visit

  Baseline; Weeks 1, 2, 3, 4, 6, and 8

• Clinical Global Impression-Improvement (CGI-I) Score by Visit

  Weeks 1, 2, 3, 4, 6, and 8

• Korean ADHD Rating Scale, 5th Edition(K-ARS-5) 50% Responder Rate by Visit

  Weeks 1, 2, 3, 4, 6, and 8

• CGI-I(Clinical Global Impression-Improvement) Responder Rate at Each Scheduled Visit

  Weeks 1, 2, 3, 4, 6, and 8

Study Arms (2)

AK-D101

EXPERIMENTAL

Participants randomized to the AK-D101 arm will receive viloxazine extended-release capsules once daily for 8 weeks. Treatment will start at 100 mg once daily. During the titration period of up to 3 weeks, the dose may be increased by 100 mg weekly at the investigator's discretion based on tolerability and response, up to a maximum of 400 mg once daily. At the end of the titration period, the maintenance dose will be determined as 200 mg, 300 mg, or 400 mg once daily and continued for at least 5 weeks.

Drug: AK-D101

Placebo

PLACEBO COMPARATOR

Participants randomized to the placebo arm will receive matching placebo capsules once daily for 8 weeks. To maintain the double-blind design, placebo-treated participants will undergo mock titration according to the same procedures used in the AK-D101 group.

Drug: Placebo

Interventions

AK-D101 DRUG

Viloxazine extended-release capsules administered orally once daily in the morning for 8 weeks. The starting dose is 100 mg once daily. The dose may be increased by 100 mg weekly during titration, up to 400 mg once daily, based on investigator assessment of tolerability and response. The maintenance dose will be 200 mg, 300 mg, or 400 mg once daily.

AK-D101

Placebo DRUG

Matching placebo capsules administered orally once daily in the morning for 8 weeks. Mock titration will be performed to maintain blinding.

Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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):
• to 11 years of age: ≥20 kg.
• to 17 years of age: ≥35 kg.

You may not qualify if:

• 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:
• Clinical laboratory tests: Results are within the normal range or, if outside the normal range, are not considered clinically significant. However, eGFR must be ≥30 mL/min/1.73 m², AST and ALT must be \<3 × upper limit of normal (ULN), and total bilirubin must be \<2 × ULN.
• Vital signs: Blood pressure, pulse rate, respiratory rate, and body temperature are within the normal range or, if outside the normal range, are not considered clinically significant.
• lead ECG: No clinically significant abnormal findings.
• 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.
• \*Hypersensitivity-related excipients: lactose, sucrose, Yellow No. 5 (Sunset Yellow FCF), and Yellow No. 203 (Quinoline Yellow WS).
• 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:
• CNS diseases, such as brain tumors, inflammatory CNS diseases, epilepsy, or cerebrovascular diseases.
• Neuromuscular diseases with childhood onset, such as Duchenne muscular dystrophy or myasthenia gravis.
• History of seizures, seizure-like symptoms, such as syncope, myoclonus, or severe muscle spasms, family history of seizure disorders in first-degree relatives, parents or siblings, and/or febrile convulsions.
• Other CNS or neuromuscular diseases that, in the investigator's medical judgment, may affect participation in the clinical trial.
• 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.

Sponsors & Collaborators

• Alvogen Korea: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

GeonUK Jeong

CONTACT

+82-2-2074-7886; GeonUk.Jeong@alvokorea.com

Jinsoo Park

CONTACT

+82-2-2074-7838; JinSoo.Park@alvokorea.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)