Evaluating NV01-A02 for children with Autism Spectrum Disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II clinical trial is designed to assess the efficacy and safety of the drug NV01-A02 in children aged 6 to 15 diagnosed with Autism Spectrum Disorder (ASD). The study employs a multicenter, randomized, double-blind, placebo-controlled methodology to ensure robust results. Participants will receive either the active drug or a placebo, allowing researchers to compare outcomes effectively. The trial aims to gather data on how well NV01-A02 can improve symptoms associated with ASD.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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Inclusion Criteria:

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)

Exclusion Criteria:

* 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

Where it's running

• Neuroventi
  Seoul, Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Neuroventi
• Email: dspark@neuroventi.com
• Phone: +82 025405630

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.