Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446193
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-31
Brief Title:
To Evaluate the Efficacy and Safety of NDTx-01 in Patients With ASD or SCD
Sponsor:
Neudive Inc
Organization:
Neudive Inc
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 11 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
The study participants will be randomized in a 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| B0081112000610 | OTHER_GRANT | Daegu-Gyueongbuk Medical Innovation Foundation KMEDI hub | None |
| RS-2023-00265178 | OTHER_GRANT | None | None |