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

NCT07678827 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2026-07-02

No results posted yet for this study

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

Interventions

DRUG

AK-D101

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.

DRUG

Placebo

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

Sponsors & Collaborators

  • Alvogen Korea

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07678827 on ClinicalTrials.gov