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Safety and Efficacy of NDTx-03 in Children and Adolescents With ASD or SCD

15. září 2026 aktualizováno: Neudive Inc.

A Multicenter, Prospective, Randomized, Evaluator-Blinded, Superiority, Confirmatory Trial to Evaluate Safety and Efficacy of NDTx-03 for Improving Social Situation Recognition and Interaction in Children and Adolescents With ASD or SCD

The purpose of this study is to evaluate the safety of NDTx-03 used together with treatment as usual (TAU) and to determine whether NDTx-03 plus TAU is more effective than TAU alone in improving social situation recognition and interaction in children and adolescents with autism spectrum disorder (ASD) or social communication disorder (SCD).

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

This is a multicenter, prospective, randomized, evaluator-blinded, superiority, confirmatory clinical trial of NDTx-03 in children and adolescents with ASD or SCD.

Participants who meet all eligibility criteria will be randomized in a 1:1 ratio to the experimental group or the control group. All participants will maintain their existing ASD/SCD-related treatment, rehabilitation, or education program as Treatment-As-Usual (TAU) during the study.

Experimental group: Participants will receive NDTx-03 in addition to TAU from baseline. NDTx-03 will be used five times per week for 8 weeks (40 sessions), consisting of a 6-week basic application period followed by a 2-week advanced application period.

Control group: Participants will receive TAU alone for 8 weeks. After the Day 56 end-of-study visit, participants who wish to receive NDTx-03 may receive it under a separate post-study access consent process. This optional post-study use is not part of the randomized clinical trial intervention or efficacy-assessment period.

Study assessments include screening, baseline (Day 0), a telephone visit at Day 21, an in-person assessment at Day 42, and the end-of-study visit at Day 56. The primary efficacy endpoint is the between-group difference in change from baseline to Day 42 in the K-VABS-II Adaptive Behavior Composite score. Secondary efficacy assessments include K-VABS-II, SRS-2, K-PRQ-CA, CGI-S, and CGI-I. Other pre-specified assessments include KIPR, EQ-5D-5L, NDTx-03 satisfaction, adolescent smartphone addiction self-diagnosis, and TAU-related expenditures. Adverse events are recorded after written informed consent. Participants with adverse events are followed for up to 30 days after the last NDTx-03 application or until resolution, as applicable.

Typ studie

Intervenční

Zápis (Odhadovaný)

156

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Jižní Korea
      • Daegu, Jižní Korea, 42472
        • Nábor
        • Daegu Catholic University Medical Center
        • Kontakt:
      • Iksan, Jižní Korea, 54538
        • Nábor
        • Wonkwang University Hospital
        • Kontakt:
      • Seoul, Jižní Korea, 05505
        • Nábor
        • Asan Medical Center
        • Kontakt:
      • Seoul, Jižní Korea, 06351
        • Nábor
        • Samsung Medical Center
        • Kontakt:
          • Yoo Sook Joung
      • Seoul, Jižní Korea, 06591
        • Nábor
        • The Catholic University of Korea, Seoul St. Mary's Hospital
        • Kontakt:
      • Seoul, Jižní Korea, 08308
        • Nábor
        • Korea University Guro Hospital
        • Kontakt:
      • Yangsan, Jižní Korea, 50612
        • Nábor
        • Pusan National University Yangsan Hospital
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  1. Children and adolescents aged 10 to 18 years.
  2. Diagnosed with Autism Spectrum Disorder (ASD) or Social Communication Disorder (SCD) by the clinical judgment of a psychiatrist according to DSM-5 diagnostic criteria, based on the Autism Diagnostic Interview-Revised (ADI-R), Korean Wechsler Intelligence Scale for Children, Fifth Edition (K-WISC-V), and clinical assessment. Previously performed ADI-R and Wechsler intelligence scale results may be used; for Wechsler intelligence scales, any test type or version may be used, including K-WISC-V, WPPSI, or WAIS.
  3. Full-Scale Intelligence Quotient (FSIQ) >= 70 or General Ability Index (GAI) >= 70 based on a Korean Wechsler intelligence scale (regardless of type or version, including K-WISC-V, WPPSI, or WAIS). Previously performed results may be used.
  4. Able to use NDTx-03 installed on a smartphone, either independently or with assistance from a parent/legal guardian.
  5. Able to comply with the recommended investigational device application schedule (5 times per week, 8 weeks, 40 sessions).
  6. Agree not to use any medical device other than the investigational device during the clinical trial.
  7. Agree that there will be no changes during the study in the regimen of medications that may significantly affect sociality. Medications being taken at screening may be continued, but total daily dose, active ingredient, and other regimen details must remain unchanged until the end-of-study visit.
  8. Agree not to participate in additional Applied Behavior Analysis (ABA) treatment/rehabilitation/education or sociality-related treatment/rehabilitation/education programs during the study. Programs being received at screening may be continued, but frequency and treatment method must remain unchanged until the end-of-study visit.
  9. The participant and parent (or legal guardian) voluntarily decide to participate and provide written informed consent/assent using the participant information sheet and informed consent form.
  10. Willing to comply with the clinical trial protocol.

Exclusion Criteria:

  1. Clinically significant behavioral problems, emotional regulation problems, psychotic symptoms, or risk of self-harm or harm to others at a level that may affect the treatment process.
  2. Severe acute or chronic medical or psychiatric disease.
  3. Serious trauma or surgery within 4 weeks before the screening date.
  4. Other severe neurological disease or disability, such as brain lesion disorder or mental disorder/disability.
  5. Currently participating in another clinical trial or participated in another clinical trial within 30 days before the screening date.
  6. Less than 24 months have elapsed since the end date of application of the investigational medical device NDTx-01 (or Buddy In) as of the screening date.
  7. Participation in a clinical trial of, or prior experience using, a digital therapeutic device or software-based intervention program that may affect efficacy assessments of this study, including cognitive function, attention, executive function, language, social development, social skills, behavior, or emotional regulation, within 12 months before the baseline visit.
  8. Within 8 weeks before baseline, a change in the dosage or regimen of medications that may significantly affect sociality, or a change in participation in treatment/rehabilitation/education programs that may significantly affect sociality.
  9. Any other case in which the investigator determines that participation is inappropriate for ethical reasons or because it may affect clinical trial results.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: NDTx-03 + TAU
NDTx-03 plus TAU from baseline through Day 56. NDTx-03 is used five times per week for 8 weeks (40 sessions), comprising a 6-week basic application period and a 2-week advanced application period.
Přístroj: NDTx-03
NDTx-03 is digital medical device software intended to improve social situation recognition and interaction in children and adolescents aged 10 to 18 years with ASD or SCD. It integrates cognitive behavioral therapy (CBT), the social information processing (SIP) model, and social skills training (SST) to address recognition and interpretation of social cues, goal setting, response generation and selection, and behavioral execution. The program adjusts difficulty according to the user's cognitive ability, diagnosis, and performance. In the experimental group, NDTx-03 is used on a smartphone five times per week for 8 weeks (40 sessions, a 6-week basic application period followed by a 2-week advanced application period).
Behaviorální: TAU
TAU consists of ASD/SCD-related treatment, rehabilitation, or education that the participant was already receiving. TAU continues during the study, but medications or treatment/rehabilitation/education programs that may significantly affect sociality should remain stable as specified in the protocol.
Jiný: TAU Alone
TAU alone from baseline through Day 56. Optional NDTx-03 provided after the end-of-study visit under a separate post-study access process is outside the clinical trial intervention and assessment period.
Behaviorální: TAU
TAU consists of ASD/SCD-related treatment, rehabilitation, or education that the participant was already receiving. TAU continues during the study, but medications or treatment/rehabilitation/education programs that may significantly affect sociality should remain stable as specified in the protocol.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from baseline in K-VABS-II Adaptive Behavior Composite (ABC) score at Day 42
Časové okno: Baseline (Visit 2, Day 0) and Day 42 (Visit 4, Day 42 +/- 3 days)
K-VABS-II is a blinded-assessor-administered scale for individuals aged 0 to 99 years that evaluates social adaptive behavior. The ABC score is based on standardized scores for Communication, Daily Living Skills, and Socialization. The change from baseline to Day 42 will be compared between groups.
Baseline (Visit 2, Day 0) and Day 42 (Visit 4, Day 42 +/- 3 days)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from baseline in CGI-S score
Časové okno: Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)
The Clinical Global Impression-Severity (CGI-S) is a clinician-rated 1-item scale scored from 1 to 7. It evaluates the current severity of symptoms compared with previous patients diagnosed with the same condition.
Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)
CGI-I score
Časové okno: Day 42 (Visit 4, Day 42 +/- 3 days) and Day 56 (Visit 5, Day 56 +/- 3 days); additional exploratory assessment at Day 98 (Visit 7, Day 98 +/- 3 days)
The Clinical Global Impression-Improvement (CGI-I) is a clinician-rated 1-item scale scored from 1 to 7. It evaluates whether the participant's mental disorder has improved compared with a specified previous time point.
Day 42 (Visit 4, Day 42 +/- 3 days) and Day 56 (Visit 5, Day 56 +/- 3 days); additional exploratory assessment at Day 98 (Visit 7, Day 98 +/- 3 days)
Change from baseline in K-VABS-II ABC score at Day 56
Časové okno: Baseline (Visit 2, Day 0) and Day 56 (Visit 5, Day 56 +/- 3 days)
The change from baseline to Day 56 in the K-VABS-II ABC score will be evaluated as a secondary efficacy endpoint. The Korean Vineland Adaptive Behavior Scales-II (K-VABS-II) Adaptive Behavior Composite (ABC) score ranges from 20 to 160, with higher scores indicating better adaptive functioning.
Baseline (Visit 2, Day 0) and Day 56 (Visit 5, Day 56 +/- 3 days)
Change from baseline in K-VABS-II domain scores
Časové okno: Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)
K-VABS-II domain scores include Communication, Daily Living Skills, and Socialization. The Korean Vineland Adaptive Behavior Scales-II (K-VABS-II) domain scores range from 20 to 160 with higher scores indicating better adaptive functioning.
Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)
Change from baseline in K-VABS-II subscale V-scale scores
Časové okno: Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)
K-VABS-II subscale V-scale scores include Receptive, Expressive, Written, Personal, Domestic, Community, Interpersonal Relationships, Play and Leisure, Coping Skills, Internalizing, and Externalizing. The V-scale scores range from 1 to 24. Higher scores indicate better adaptive functioning for Receptive, Expressive, Written, Personal, Domestic, Community, Interpersonal Relationships, Play and Leisure, and Coping Skills, whereas higher Internalizing and Externalizing scores indicate greater maladaptive behavior.
Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)
Change from baseline in SRS-2 total score
Časové okno: Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)
The Korean Social Responsiveness Scale-2 (SRS-2) is a parent-rated 65-item scale used to identify the presence and severity of social impairment in autism and distinguish it from impairment related to other disorders. The total score ranges from 0 to 195 with higher scores indicating greater severity of social impairment.
Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)
Change from baseline in SRS-2 subscale T-scores
Časové okno: Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)
The Korean Social Responsiveness Scale-2 (SRS-2) is a parent-rated 65-item scale used to identify the presence and severity of social impairment in autism and distinguish it from impairment related to other disorders. Subscale T-scores include Social Awareness, Social Cognition, Social Communication, Social Motivation, Restricted Interests and Repetitive Behavior (RRB), and Social Communication and Interaction (SCI). The subscale T-scores are estimated to range from 34 to 128 with higher scores indicating greater severity of social impairment.
Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)
Change from baseline in K-PRQ-CA score
Časové okno: Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)
The Korean Parenting Relationship Questionnaire - Child & Adolescent (K-PRQ-CA) is a parent/caregiver-rated scale for children and adolescents from elementary school through high school. It measures the parent or primary caregiver perspective on the parent-child relationship and consists of 71 items. The K-PRQ-CA subscale T-scores are estimated to range from 20 to 80 (T-score means 50, standard deviation 10). Higher scores indicate better parent-child relationships functioning for Attachment, Communication, Discipline, Involvement, Parenting Confidence, and Satisfaction with School, whereas higher Relational Frustration scores indicate greater relational frustration.
Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from baseline in EQ-5D-5L score
Časové okno: Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)
The Korean version of the EuroQol Five Dimension Five Level Scale (EQ-5D-5L) is a standardized instrument for describing and valuing health-related quality of life. It consists of five items rated on a 1- to 5-point scale.
Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)
NDTx-03 satisfaction questionnaire score
Časové okno: Day 56 (Visit 5)
The NDTx-03 satisfaction questionnaire assesses the participant's experience with NDTx-03. It consists of four items rated on a 0- to 10-point scale.
Day 56 (Visit 5)
Number and percentage of participants with treatment-emergent adverse events (TEAEs)
Časové okno: From investigational device application through the end of study, up to Day 56 (Visit 5, Day 56 +/- 3 days)
Adverse events occurring after investigational device application will be classified as TEAEs and analyzed for safety. AEs occurring before application of the investigational device will be recorded as pretreatment AEs but excluded from the TEAE analysis.
From investigational device application through the end of study, up to Day 56 (Visit 5, Day 56 +/- 3 days)
Change from baseline in KIPR score
Časové okno: Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)

The Korean Inventory of Peer Relationships (KIPR) is a self-report assessment for children and adolescents that evaluates peer relationships and consists of 64 items.

The KIPR subscale and Total T-scores are estimated to range from 20 to 80, with higher scores indicating greater difficulties in peer relationships.
Baseline (Visit 2, Day 0), Day 42 (Visit 4, Day 42 +/- 3 days), and Day 56 (Visit 5, Day 56 +/- 3 days)
Change from baseline in adolescent smartphone addiction self-diagnosis score
Časové okno: Baseline (Visit 2, Day 0) and Day 56 (Visit 5, Day 56 +/- 3 days)
The Adolescent Smartphone Addiction Self-Diagnosis Scale is a self-report tool developed based on internet addiction and mobile phone addiction scales. It consists of 15 items rated on a 4-point scale. The total score ranges from 15 to 60 with higher scores indicating a greater risk of smartphone addiction.
Baseline (Visit 2, Day 0) and Day 56 (Visit 5, Day 56 +/- 3 days)
Monthly TAU-related total expenditure and medical cost
Časové okno: Screening (Visit 1, Day -28 to Day 0)
TAU-related monthly total expenditure and monthly medical cost will be collected and summarized as basic data for economic evaluation. TAU-related monthly total expenditure is defined as the sum of the average monthly costs actually incurred for ASD/SCD-related medical services, pharmacological treatment, non-pharmacological therapy, treatment, rehabilitation, and educational programs. Monthly medical cost is defined as the average monthly out-of-pocket cost directly related to medical consultations, examinations, prescription and dispensing, and medical institution-based treatment and rehabilitation.
Screening (Visit 1, Day -28 to Day 0)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Neudive Inc.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Yoo Sook Joung, MD., PhD, Samsung Medical Center

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

15. září 2026

Primární dokončení (Odhadovaný)

1. prosince 2026

Dokončení studie (Odhadovaný)

1. září 2027

Termíny zápisu do studia

První předloženo

13. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

13. srpna 2026

První zveřejněno (Aktuální)

18. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

17. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • ND-06
  • R25TA0120748700 (Jiné číslo grantu/financování: National Center for Mental Health)

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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