Phase 3 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:

• The patient must have a parent or legal guardian who is willing to take responsibility for the patient's safety, share information about their condition, and attend study visits with them.
• The parent or legal guardian must sign a written consent form, and if the patient is old enough to understand, they should also sign an assent form.
• The patient must be between 13 and 17 years of age (the trial is currently only enrolling this age group, though the trial design includes ages 5 to 17).
• The patient must have a confirmed primary diagnosis of Autism Spectrum Disorder (ASD), verified using a specific structured assessment tool used by the trial team.
• The patient must score above 18 on a particular rating scale that measures irritability (called the ABC-I subscale) at two points during the screening process.
• The patient must score above 4 on a clinical severity rating scale specifically related to irritability connected to ASD, again at two points during screening.

Who may not be able to join:

• Patients whose main psychiatric diagnosis is something other than ASD — though exceptions may apply for those who also have Attention Deficit Hyperactivity Disorder (ADHD), provided their ADHD medication has remained the same for at least 30 days before screening and is expected to stay the same throughout the study.
• Patients who also have a mild or moderate intellectual disability may still be considered, but those with severe or profound intellectual disability are not eligible.
• Patients who have been diagnosed with Rett syndrome or Fragile X syndrome, either in the past or currently.
• Patients who, in the trial doctor's judgment, carry a significant risk of suicidal behaviour during the study.
• Patients who, within the 6 months before screening, have indicated certain higher-level thoughts of suicide on a standardised safety questionnaire (called the Columbia-Suicide Severity Rating Scale, items 3, 4, or 5).
• Patients who have made one or more suicide attempts in the 2 years before screening.
• Patients considered to be in immediate danger of harming themselves or others.

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