ADHD, Attention Deficit Hyperactivity Disorder, Attention-Deficit / Hyperactivity Disorder
Conditions
Keywords
ADHD, Attention-Deficit/Hyperactivity Disorder, Viloxazine, Viloxazine Extended-Release, Viloxazine ER, AK-D101, Qelbree, Korean Population, Bridging Study, Pediatric ADHD, Adolescent ADHD
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.
Detailed description
This study is a randomized, double-blind, placebo-controlled, multicenter, Phase 3 bridging clinical trial in Korean children and adolescents aged 6 to 17 years with ADHD. At Screening, written informed consent will be obtained from the participant's parent or legal representative, and assent will be obtained from the participant, as applicable, before any study-specific procedures are performed. Eligibility will be assessed at Screening and confirmed at Baseline. Eligible participants will be stratified by study site and age group, defined as children aged 6 to 11 years and adolescents aged 12 to 17 years, and randomized in a 1:1 ratio to the AK-D101 group or placebo group through an Interactive Web Response System (IWRS). The study is double-blind; participants, investigators, site personnel, sponsor personnel, CRO personnel, and other personnel involved in study conduct or interpretation will remain blinded to treatment assignment. Participants will receive the investigational product once daily in the morning for a total of 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 dose of 400 mg once daily. At the end of titration, the maintenance dose will be determined as 200 mg, 300 mg, or 400 mg and will be continued for at least 5 weeks. To maintain blinding, placebo-treated participants will undergo mock titration using the same procedures. Participants will visit the study site weekly from Visit 3 to Visit 6 for efficacy and safety assessments. Visits 7 and 9 will be conducted as phone-call visits to assess investigational product administration, concomitant medications or therapies, and adverse events. Visits 8, 10, and 11 will be on-site visits for efficacy and/or safety assessments. Visit 10 at Week 8/Day 56 is the End of Treatment visit. Visit 11 at Week 9/Day 63 is the End of Study visit for final safety follow-up. Participants who discontinue investigational product before completing the planned 56-day treatment period or withdraw early will undergo an Early Termination visit, with procedures corresponding to the End of Treatment visit, and will be followed until End of Study whenever feasible. Pharmacokinetic assessments will be conducted in participants who consent to PK blood sampling. PK blood sampling will be performed at two blood sampling visits, Visit 3 and one of Visit 6, Visit 8, or Visit 10, according to the protocol-defined schedule.
Interventions
DRUGAK-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.
DRUGPlacebo
Matching placebo capsules administered orally once daily in the morning for 8 weeks. Mock titration will be performed to maintain blinding.
Sponsors
Alvogen Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Korean male or female subjects who are ≥6 and ≤17 years of age at the time of written informed consent. 2. 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). 3. Subjects with a Korean ADHD Rating Scale, 5th Edition (K-ARS-5) Total Score of ≥28 at Visit 1 (Screening) and Visit 2 (Baseline). 4. Subjects with a Clinical Global Impression-Severity (CGI-S) score of ≥4 at Visit 1 (Screening) and Visit 2 (Baseline). 5. Subjects who meet the following body weight criteria at Visit 1 (Screening): * 6 to 11 years of age: ≥20 kg. * 12 to 17 years of age: ≥35 kg. 6. Subjects who agree not to initiate or take any ADHD medication other than the investigational medicinal product during the study. Subjects who are taking ADHD medication at Visit 1 (Screening) but whose ADHD symptoms are not adequately controlled with their current ADHD medication, as demonstrated by meeting Inclusion Criterion 3, may participate if they meet all other inclusion/
Exclusion criteria
and have discontinued ADHD medication at least 7 days before Visit 2 (Baseline). 7. 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. * 12-lead ECG: No clinically significant abnormal findings. 8. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 8 in K-ARS-5 (Korean ADHD Rating Scale, 5th Edition) Total Score | Baseline to Week 8, End of Treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Clinical Global Impression-Improvement (CGI-I) Score by Visit | Weeks 1, 2, 3, 4, 6, and 8 | 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. |
| Korean ADHD Rating Scale, 5th Edition(K-ARS-5) 50% Responder Rate by Visit | Weeks 1, 2, 3, 4, 6, and 8 | 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. |
| CGI-I(Clinical Global Impression-Improvement) Responder Rate at Each Scheduled Visit | Weeks 1, 2, 3, 4, 6, and 8 | 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. |
Countries
South Korea
Contacts
CONTACTGeonUK Jeong
CONTACTJinsoo Park
Outcome results
None listed