A Phase 3 Study of Viloxazine ER Capsules in Korean Children and Adolescents With ADHD
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-17
SponsorAlvogen Korea
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
12-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.
Trial design
Design model
Parallel
Treatments tested in this trial
AK-D101
DrugViloxazine 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
DrugMatching placebo capsules administered orally once daily in the morning for 8 weeks. Mock titration will be performed to maintain blinding.
Treatment groups
156 Participants
are divided into 2 treatment groupsGroup A: AK-D101Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline to Week 8, End of TreatmentSecondary outcomes
1
Change From Baseline in the Korean ADHD Rating Scale, 5th Edition Total Score at Each Scheduled Visit
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.
Time frame
Baseline; Weeks 1, 2, 3, 4, 6, and 82
Clinical Global Impression-Improvement (CGI-I) Score by Visit
The Clinical Global Impression-Improvement (CGI-I) scale is used to assess overall clinical improvement compared with baseline. The CGI-I score ranges from 1 to 7, where 1 indicates "very much improved" and 7 indicates "very much worse." Lower scores indicate greater improvement.
Time frame
Weeks 1, 2, 3, 4, 6, and 83
Korean ADHD Rating Scale, 5th Edition(K-ARS-5) 50% Responder Rate by Visit
The Korean ADHD Rating Scale, 5th Edition (K-ARS-5) Total Score ranges from 0 to 54, with higher scores indicating more severe ADHD symptoms. A K-ARS-5 50% responder is defined as a participant with at least a 50% reduction from baseline in the K-ARS-5 Total Score.
Time frame
Weeks 1, 2, 3, 4, 6, and 84
CGI-I(Clinical Global Impression-Improvement) Responder Rate at Each Scheduled Visit
The Clinical Global Impression-Improvement (CGI-I) scale ranges from 1 to 7, where 1 indicates "very much improved" and 7 indicates "very much worse." Lower scores indicate greater improvement. A CGI-I responder is defined as a participant with a CGI-I score of 1 or 2.
Time frame
Weeks 1, 2, 3, 4, 6, and 8Sponsors and contacts
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Source ClinicalTrials.gov
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