Tests NV01-A02 against placebo in children with autism spectrum disorder
Tests the drug NV01-A02 against a placebo in children with autism spectrum disorder.
Plain-language title generated from the registry record
Registry title: Phase II Clinical Trial to Evaluate the Efficacy and Safety of NV01-A02 in Children With Autism Spectrum Disorder
Key facts
- Where
- Seoul, South KoreaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 15 years old?
Source: NCT06951854, who can take part
Where in South Korea
- NeuroventiSeoul, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Neuroventi Inc.
- Trial code
- NCT06951854
- Record updated
- 30 April 2025
- Original description
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).Read full original descriptionShow less
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).
Inclusion: -; 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:; Deficits in social-emotional reciprocity; Deficits in nonverbal communicative behaviors used for social interaction; 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:; Stereotyped or repetitive motor movements, use of objects, or speech; Insistence on sameness, inflexible adherence to routines, or ritualized patterns of verbal or nonverbal behavior; Highly restricted, fixated interests that are abnormal in intensity or focus; 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).
Exclusion: Individuals weighing less than 16 kg or more than 70 kg; Individuals identified during screening with any of the following medical histories, comorbid conditions, or surgical histories:; Severe psychiatric disorders (other than autism spectrum disorder) that may affect participation in the clinical trial; History of organic brain disease, neurological disorders, or epilepsy/seizures that are not fully controlled by medication or non-pharmacologic surgical treatment (Note: Participants with a history of simple febrile seizures may be included at the investigator's discretion); Severe peripheral arterial disease or coronary insufficiency; Presence or history of psychotic symptoms such as delusions or hallucinations (e.g., worsening or recurrence of psychiatric illness); Gastrointestinal diseases (e.g., active peptic ulcers) or history of surgery that may affect absorption of the investigational medicinal product (Note: Participants with a history of simple appendectomy or hernia surgery may be included); Individuals displaying serious self-injurious or aggressive behavior requiring medical intervention during the screening period, as determined by the investigator; Individuals with sensory abnormalities such as congenital hearing loss.