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 and able to look after their wellbeing, share information about their condition, and attend study visits with them.
• The parent or legal guardian must give written consent to participate, and if the child is old enough to understand (as decided by the study doctor), the child should also give written agreement.
• Patients who are male or female and between 5 and 17 years old — note that currently only patients aged 13 to 17 years old are being enrolled.
• Patients who have been formally diagnosed with Autism Spectrum Disorder (ASD) as their main diagnosis, confirmed using a specific structured assessment tool used by the study team.
• Patients who score above 18 on a specific scale that measures irritability-related behaviours (called the ABC-I subscale), checked at two points before the study begins.
• Patients whose ASD-related irritability is rated as more than 4 on a clinical severity scale (called the CGI-S), checked at two points before the study begins.

Who may not be able to join:

• Patients whose main diagnosis is a psychiatric condition other than ASD — though some exceptions apply: patients with ADHD may still be considered if they have been on a stable ADHD medication for at least 30 days before screening and are expected to stay on the same treatment throughout the study; patients with mild or moderate intellectual disability (as defined by standard diagnostic criteria) may also be considered, but those with severe or profound intellectual disability are not eligible.
• Patients who have a history of, or have been diagnosed with, Rett syndrome or Fragile X syndrome.
• Patients who, in the study doctor's opinion, are at significant risk of suicidal behaviour during the study — this includes patients who have indicated certain levels of suicidal thoughts on a standard safety scale (called the C-SSRS) in the 6 months before screening, patients who have made one or more suicide attempts in the 2 years before screening, or patients considered to be in immediate danger of harming themselves or others.

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