NCT06446193

To Evaluate the Efficacy and Safety of 'NDTx-01' in Patients With ASD or SCD

A Multi-center, Randomized, Assessor-blind, Superiority, Confirmatory Clinical Trial to Assess Safety and Efficacy of Cognitive Therapy Software 'NDTx-01' for Improving Social Awareness and Interaction in Children and Adolescents With Autism Spectrum Disorder (ASD) or Social Communication Disorder (SCD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Neudive Inc. · Industry
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the superiority of the treatment of cognitive therapy software 'NDTx-01' compared to TAU (Treatment-As-Usual).

Detailed description

This confirmatory clinical trial aims to demonstrate the superiority of 'NDTx-01' by comparing and evaluating the efficacy and safety of the experimental group applying 'NDTx-01' with TAU (Treatment-As-Usual) and the control group applying TAU only. The study participants will be randomized in a 1:1 as experimental group and control group. The experimental group applies 'NDTx-01' 30 times for 6 weeks (5 times a week) with TAU and the control group gets TAU only. For the primary purpose, the change in the adaptive behavior combination (ABC) score of the Korean version of the Vineland Adaptive Behavior Scale-II (K-VABS-II) at 42 days compared to the baseline will be evaluated.

Conditions

• Autism Spectrum Disorder
• Social Communication Disorder

Interventions

Type	Name	Description
DEVICE	NDTx-01	NDTx-01 intervention: Run 'NDTx-01' application on a smartphone 5 times a week, for 6 weeks, 30 sessions in total.
BEHAVIORAL	TAU	TAU: Autism Spectrum Disorders(ASD) or Social Communication Disorders(SCD)-related treatment/rehabilitation/education

Timeline

• Start date: 2024-08-14
• Primary completion: 2025-02-06
• Completion: 2025-02-06
• First posted: 2024-06-06
• Last updated: 2025-02-12

Locations

5 sites across 1 country: South Korea