Trial · Interventional
RecruitingPhase 2Registry dataPhase 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
- Ph 2
Phase II Clinical Trial to Evaluate the Efficacy and Safety of NV01-A02 in Children With Autism Spectrum Disorder
NCT069518541 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.
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
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