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
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).
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⁃ 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)