Autism Spectrum Disorder Trial, Recruiting NCT07242625 Sponsor: Neudive Inc. Condition: Autism Spectrum Disorder
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Autism Spectrum Disorder Trial, Recruiting

NCT07242625
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Children and adolescents between 5 and 12 years old at the time of screening
  • People who have been diagnosed with ADHD or Autism Spectrum Disorder (ASD) by a psychiatrist, using standard diagnostic guidelines (DSM-5); for ASD, the diagnosis may also be supported by specific standardised assessment tools
  • People whose IQ score is 65 or above, as measured by a standard intelligence test
  • People who are able to use a tablet-based app called 'NDTx-02', either on their own or with help from a parent or guardian
  • People who are able to follow the recommended app schedule, which involves 30 sessions over 6 weeks, used 5 times per week
  • People whose parent or guardian agrees not to start or change any treatments, therapies, or medications during the study period — continuing existing treatments is allowed
  • People whose parent or legal guardian voluntarily agrees to take part and signs a written consent form
  • People willing to follow all clinical trial procedures

Who may not be able to join:

  • People who have significant behavioural problems, difficulty regulating emotions, psychotic symptoms, or risk of self-harm or harm to others that could interfere with the treatment process
  • People with a severe ongoing or long-term medical or mental health condition
  • People who have experienced serious trauma or had surgery within the 4 weeks before screening
  • People with other significant disabilities, such as serious neurological conditions (for example, brain lesions or certain mental disorders)
  • People who are currently in another clinical trial, or who have taken part in one within the 30 days before screening
  • People whose medication dose or type — particularly medications that could affect thinking or concentration — has changed within the 4 weeks before the baseline visit
  • People who have started or changed a therapy, education, or rehabilitation program that could significantly affect thinking or concentration within the 4 weeks before the baseline visit
  • People who have taken part in a clinical trial of, or previously used, software designed to improve thinking skills or daily living within the 12 weeks before the baseline visit
  • People whom the trial investigator considers unsuitable for participation for ethical reasons or because their participation could affect the reliability of the trial results

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Yoo-Sook Joung, MD, PhD, Samsung Medical Center

Phone: +82-2-6959-9933

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Neudive Inc.
Registry
ClinicalTrials.gov
Start date
16 October 2025
Est. completion
1 April 2026

Where this trial is recruiting

🇰🇷 South Korea

Primary endpoints

K-BRIEF-2 (Behavior Rating Inventory of Executive Function, Second Edition)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov