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Trial · Interventional

RecruitingPhase 2Registry data

Phase II Clinical Trial to Evaluate the Efficacy and Safety of NV01-A02 in Children With Autism Spectrum Disorder

Overview

Status
Recruiting
Phase
Phase 2
Enrollment
105 participants (estimated)
Sponsor
Neuroventi Inc. · Industry
Design
Randomized · Quadruple masking
Countries
1 country

South Korea

Start
1 Apr 2025
Primary completion
1 Sept 2025 (estimated)
Completion
1 Dec 2026 (estimated)
First posted
30 Apr 2025
Last update posted
30 Apr 2025
Conditions
Autism Spectrum Disorder (ASD

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202520262027
  1. Ph 2

    Phase II Clinical Trial to Evaluate the Efficacy and Safety of NV01-A02 in Children With Autism Spectrum Disorder

    NCT06951854

    1 Apr 2025 to est. 1 Dec 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is a multicenter, randomized, double-blind, placebo-controlled, therapeutic exploratory Phase 2 clinical trial designed to evaluate the efficacy and safety of NV01-A02 in pediatric participants diagnosed with Autism Spectrum Disorder (ASD).

Interventions

  • Drug: NV01-A02Drug
  • Drug: Placebo (ZP8396)Drug

Arms2

  • Experimental

    Drug: NV01-A02

    Participants will receive different dose levels of the investigational drug. The drug will be administered orally once daily

  • Placebo comparator

    Drug: Placebo (ZP8396)

    Participants will receive different dose levels of the investigational drug. The drug will be administered orally once daily

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change from baseline in the composite scores of the major domains of the Korean Vineland Adaptive Behavior Scales-II (K-Vineland-II) at Week 8 after administration.

    Time frame · From enrollment to the end of treatment at 8 weeks

    Registry description

    Change from baseline in the composite scores of the major domains of the Korean Vineland Adaptive Behavior Scales-II (K-Vineland-II) at Week 8 after administration.\* For children under 7 years of age, the composite score refers to the standard scores of all four major domains: Communication, Daily Living Skills, Socialization, and Motor Skills. For children aged 7 years and older, the composite score refers to the standard scores of the three domains excluding Motor Skills: Communication, Daily Living Skills, and Socialization.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 6 Years up to 15 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: \- Inclusion Criteria: Children aged 6 to 15 years (inclusive) as of the date of written consent Individuals who meet all the diagnostic criteria for Autism Spectrum Disorder (ASD) as outlined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) DSM-5 Diagnostic Criteria for Autism Spectrum Disorder (ASD): * Persistent deficits in social communication and social interaction across multiple contexts, as manifested by all of the following: A. Deficits in social-emotional reciprocity B. Deficits in nonverbal communicative behaviors used for social interaction C. Deficits in developing, maintaining, and understanding relationships ② Restricted, repetitive patterns of behavior, interests, or activities, as manifested by at least two of the following: A. Stereotyped or repetitive motor movements, use of objects, or speech B. Insistence on sameness, inflexible adherence to routines, or ritualized patterns of verbal or nonverbal behavior C. Highly restricted, fixated interests that are abnormal in intensity or focus D. Hyper- or hyporeactivity to sensory input or unusual interest in sensory aspects of the environment ③ Symptoms must be present in the early developmental period (but may not become fully manifest until social demands exceed limited capacities, or may be masked by learned strategies later in life) Exclusion Criteria: * Individuals weighing less than 16 kg or more than 70 kg Individuals identified during screening with any of the following medical histories, comorbid conditions, or surgical histories: * Severe psychiatric disorders (other than autism spectrum disorder) that may affect participation in the clinical trial * History of organic brain disease, neurological disorders, or epilepsy/seizures that are not fully controlled by medication or non-pharmacologic surgical treatment (Note: Participants with a history of simple febrile seizures may be included at the investigator's discretion) * Severe peripheral arterial disease or coronary insufficiency * Presence or history of psychotic symptoms such as delusions or hallucinations (e.g., worsening or recurrence of psychiatric illness) * Gastrointestinal diseases (e.g., active peptic ulcers) or history of surgery that may affect absorption of the investigational medicinal product (Note: Participants with a history of simple appendectomy or hernia surgery may be included) * Individuals displaying serious self-injurious or aggressive behavior requiring medical intervention during the screening period, as determined by the investigator * Individuals with sensory abnormalities such as congenital hearing loss

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