Phase 3 Autism Spectrum Disorder Trial, Not Yet Recruiting

Written by an AI model from the 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 participant is between 6 and 25 years old (inclusive).
• The participant is at a healthy weight, as judged by the lead doctor running the trial.
• A parent or legal guardian has given written consent, following local rules.
• The participant is able to follow the requirements of the trial.
• The participant has been diagnosed with moderate or severe autism spectrum disorder (ASD — Level II or III) using an approved diagnostic tool, based on the DSM-5 guidelines.
• Any treatments, therapies, or medications for ASD symptoms have been unchanged for at least 12 weeks before joining and ideally remain unchanged throughout the trial.
• The participant is able to swallow liquid.
• The person giving consent is able to understand what the study involves.

Who may not be able to join:

• The participant currently has a diagnosis of bipolar disorder, psychosis, schizophrenia, schizoaffective disorder, or active major depression.
• The participant has another condition (for example, ADHD) that is more prominent in their day-to-day life than their ASD diagnosis.
• The participant has a condition that causes progressive deterioration of their health over time (confirm with trial site).
• The participant's epilepsy medication has been changed in the last 12 weeks.
• The participant is currently taking any of the following medications: omeprazole, lansoprazole, tolbutamide, warfarin, sirolimus, everolimus, temsirolimus, tacrolimus, clobazam, repaglinide, pioglitazone, rosiglitazone, montelukast, bupropion, or efavirenz.
• The participant has used recreational or medical cannabis, or cannabis-based medicines (including Sativex® or Epidiolex®), in the last 12 weeks and is not willing to stop using them for the whole trial.
• The participant has a known or suspected allergy or sensitivity to cannabinoids or any ingredients in the trial medication.
• The participant has a liver function that is outside of a normal healthy range, based on blood test results (confirm with trial site).
• The participant is male, has gone through puberty, and is not willing to use a condom or remain sexually abstinent during the trial and for 12 weeks after it ends (unless permanently sterile).
• The participant is female, is able to become pregnant, and is not willing to use a reliable form of contraception during the trial and for 12 weeks after it ends (unless permanently sterile or postmenopausal).
• The participant is female and is currently pregnant, breastfeeding, or planning to become pregnant during the trial or within 12 weeks after it ends.
• The participant has had brain surgery or a serious brain injury within the past year.
• The participant has any other significant health condition that the investigator believes could affect their safety, the trial results, or their ability to take part.
• The participant has any physical health findings that the investigator believes could put them at risk if they joined the trial.
• The participant has any history of suicidal behaviour, or has had serious suicidal thoughts in the last 12 weeks or at the time of screening (confirm with trial site).
• The participant has donated blood in the past 12 weeks and is not willing to avoid donating blood during the trial.
• The participant has a known or suspected history of alcohol or drug misuse, or tests positive for drugs of abuse at screening (unless explained by a known medication).
• The participant has already taken part in this trial before.
• The participant plans to travel outside their home country during the trial, unless they have confirmed that the trial medication is legally permitted in the destination country or region.

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