Evaluating NV01-A02 for children with Autism Spectrum Disorder
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 study is testing a new drug called NV01-A02 to see if it can help improve symptoms in children aged 6 to 15 with Autism Spectrum Disorder.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 6 Years to 15 Years |
| Sex | All |
| Sponsor | Neuroventi Inc. Industry-sponsored |
| Locations | 1 site (Seoul, Seoul) |
| Trial ID | NCT06951854 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 to 15 years who have been diagnosed with Autism Spectrum Disorder according to DSM-5 criteria.
Not a fit: Patients who do not meet the diagnostic criteria for Autism Spectrum Disorder or are outside the age range of 6 to 15 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for children with Autism Spectrum Disorder, potentially improving their social communication and interaction skills.
How similar studies have performed: While there have been various studies on treatments for Autism Spectrum Disorder, the specific approach of using NV01-A02 is novel and has not been extensively tested in previous trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seoul, Seoul
- Neuroventi — Seoul, Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Neuroventi
- Email: dspark@neuroventi.com
- Phone: +82 025405630
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.