Actively Recruiting
Phase II Clinical Trial to Evaluate the Efficacy and Safety of NV01-A02 in Children With Autism Spectrum Disorder
Led by Neuroventi Inc. · Updated on 2025-04-30
105
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Phase II Clinical Trial to Evaluate the Efficacy and Safety of NV01-A02 in Children With Autism Spectrum Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 to 15 years (inclusive) at the time of consent
- Diagnosed with Autism Spectrum Disorder (ASD) according to DSM-5 criteria
- Persistent difficulties in social communication and interaction across multiple settings
- At least two types of restricted, repetitive behaviors or interests as defined by DSM-5
- Symptoms present from early developmental period, even if fully apparent later
You will not qualify if you...
- Weight less than 16 kg or more than 70 kg
- Severe psychiatric disorders other than ASD that may impact trial participation
- History of uncontrolled organic brain disease, neurological disorders, or epilepsy/seizures
- Severe peripheral arterial disease or coronary insufficiency
- History or presence of psychotic symptoms such as delusions or hallucinations
- Gastrointestinal diseases or surgeries affecting drug absorption (excluding simple appendectomy or hernia surgery)
- Serious self-injurious or aggressive behavior requiring medical intervention during screening
- Sensory abnormalities including congenital hearing loss
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Neuroventi
Seoul, Seoul, South Korea, 06100
Actively Recruiting
Research Team
N
Neuroventi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here