RecruitingPhase 2NCT06951854

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

A Multi-center, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory Phase II Clinical Trial to Evaluate the Efficacy and Safety of NV01-A02 in Children With Autism Spectrum Disorder

Sponsor

Neuroventi Inc.

Enrollment

105 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Autism Spectrum Disorder (ASD)

Summary

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).

Eligibility

Min Age: 6 YearsMax Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Drug: NV01-A02 and Drug: Placebo (ZP8396) for people with autism spectrum disorder (asd). The study is currently recruiting participants at 1 location. People eligible for this study include aged 6 Years to 15 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDrug: NV01-A02

NV01-A02 will be administered orally at a different dose once daily for 8 weeks. The formulation is a white, film-coated tablet, designed for use in patients with mild to moderate cognitive impairment.

DRUGDrug: Placebo (ZP8396)

ZP8396 is a matching placebo tablet administered orally once daily for 8 weeks. The placebo is identical in appearance to NV01-A02 but contains no active ingredient.