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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
105
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.
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.
Neuroventi
Seoul, Seoul, South Korea
RECRUITINGChange 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.
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.
Time frame: From enrollment to the end of treatment at 8 weeks
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