Phase 2 Autism Spectrum Disorder Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Boys between the ages of 5 and 14 years old
• People with a formal diagnosis of Autism Spectrum Disorder (ASD) based on recognised diagnostic guidelines (DSM-5)
• People who have had a specific standardised autism assessment (called the ADOS-2) completed within the last 2 years, with a score of 7 or above on the relevant section
• People whose autism-related social difficulties are rated as at least moderately severe on a clinician's rating scale (CGI-S score of 4 or higher for socialisation symptoms)
• People with a non-verbal thinking ability score above 70 on a standardised test (called the Leiter-3)
• People whose social skills score falls below 75 on a standardised assessment of daily living skills (the Vineland Adaptive Behavior Scales, Third Edition)
• People who are sexually active or may become sexually active during the trial must agree to use condoms with spermicide during the treatment period and for at least 30 days after the last dose of the study medication
• People who agree to wear sunscreen and skin-covering clothing as much as the child can tolerate, during the treatment period and for at least 30 days after the last dose of study medication
• People who live within a 90-minute car ride from the trial site
• Children and their parent, guardian, or caregiver who speak English
• A parent or legal guardian who is willing to sign a consent form on behalf of the child

Who may not be able to join:

• People whose ASD is linked to a known genetic or medical syndrome (such as Fragile X, Angelman syndrome, or Down's syndrome)
• People whose weight is at or below the 5th percentile for their age (confirm with trial site)
• People who are unable to tolerate having blood drawn or providing a urine sample
• People who currently have an active infection (such as a cold, flu, strep throat, or COVID-19)
• People with severe additional health conditions — such as psychosis, epilepsy that is not controlled by medication, or significant vision or hearing impairment — that could interfere with the trial; note that controlled epilepsy may be allowed if there has been no seizure in the past year (confirm with trial site)
• People with significant problems affecting major organs, particularly the liver, kidneys, or heart, or with relevant adrenal gland abnormalities (confirm with trial site for specific test thresholds)
• People who have been hospitalised in the 2 months before the screening appointment
• People who have started or changed any medication in the 2 months before the screening appointment
• People who have started or changed a formal behavioural or psychological therapy program in the 2 months before the screening appointment
• People for whom there are plans to start or change medications or formal therapy programs during the trial
• People currently taking certain prescription medications that may interact with the study drug (KZ101), including some antibiotics (sulfonamides), chlorpromazine, or blood thinners (confirm with trial site for the full list)
• People currently enrolled in another clinical trial, or who have received any experimental treatment within 30 days of the screening appointment
• People taking more than 3 medications aimed at managing behavioural symptoms related to ASD or related conditions such as ADHD, anxiety, or depression (note: anti-seizure medications and medications unrelated to behavioural symptoms do not count toward this limit)
• People with a history of serious skin reactions
• People with a known allergy, intolerance, or sensitivity to any drug, including sensitivity to light (photosensitivity)
• People who are unable or unwilling to follow the requirements of the trial

Important: Always verify eligibility with the trial site directly before applying.