Phase II Clinical Trial to Evaluate the Efficacy and Safety of NV01-A02 in Children With Autism Spectrum Disorder
NCT ID: NCT06951854
Last Updated: 2025-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
105 participants
INTERVENTIONAL
2025-04-01
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Drug: NV01-A02
Participants will receive different dose levels of the investigational drug. The drug will be administered orally once daily
Drug: NV01-A02
NV01-A02 will be administered orally at a different dose once daily for 8 weeks. The formulation is a white, film-coated tablet, designed for use in patients with mild to moderate cognitive impairment.
Drug: Placebo (ZP8396)
Participants will receive different dose levels of the investigational drug. The drug will be administered orally once daily
Drug: Placebo (ZP8396)
ZP8396 is a matching placebo tablet administered orally once daily for 8 weeks. The placebo is identical in appearance to NV01-A02 but contains no active ingredient.
Interventions
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Drug: NV01-A02
NV01-A02 will be administered orally at a different dose once daily for 8 weeks. The formulation is a white, film-coated tablet, designed for use in patients with mild to moderate cognitive impairment.
Drug: Placebo (ZP8396)
ZP8396 is a matching placebo tablet administered orally once daily for 8 weeks. The placebo is identical in appearance to NV01-A02 but contains no active ingredient.
Eligibility 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 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
6 Years
15 Years
ALL
No
Sponsors
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Neuroventi Inc.
INDUSTRY
Responsible Party
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Locations
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Neuroventi
Seoul, Seoul, South Korea
Countries
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Central Contacts
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Facility Contacts
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Neuroventi
Role: primary
Other Identifiers
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NV01-A02
Identifier Type: -
Identifier Source: org_study_id