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

Conditions

• ADHD
• Attention Deficit Hyperactivity Disorder
• Attention-Deficit / Hyperactivity Disorder

Eligibility Criteria

Sex

ALL

Age

6 Years - 17 Years

Healthy Volunteers

Not accepted

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

Study Details

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.

Key Dates

First listed

Jul 1, 2026

Start date

Jul 31, 2026

Status verified

Jun 2026

Primary completion

Sep 30, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

156 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: AK-D101
  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.
• Placebo Comparator: Placebo
  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.

Primary Outcome Measure

Change From Baseline to Week 8 in K-ARS-5 (Korean ADHD Rating Scale, 5th Edition) Total Score [ Time Frame: Baseline to Week 8, End of Treatment ]

Central Contacts

• GeonUK Jeong
  +82-2-2074-7886
  [email protected]
• Jinsoo Park
  +82-2-2074-7838
  [email protected]

Find similar trials

Related Studies

• Motor Attention Training for Attention Deficit Hyperactivity Disorder (ADHD)
  Recruiting · University of Wisconsin, Madison · Madison, Wisconsin
• Virtual Reality Attention Management
  Recruiting · University of California, Davis · Sacramento, California
• Stimulant Effects on Disruptive Behavior
  PHASE4 · Recruiting · Matthew J O'Brien, PhD, BCBA-D · Iowa City, Iowa
• Carboxylesterase 1 Genetic Variation and Methylphenidate in ADHD
  PHASE4 · Recruiting · Icahn School of Medicine at Mount Sinai · Gainesville, Florida