Phase 2 Autism Spectrum Disorder Trial, Completed

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 person weighs at least 12 kilograms (approximately 26 pounds).
• The person (if old enough to understand, in the doctor's opinion) and their parent(s) or legal guardian are willing and able to give their agreement to take part in the trial.
• The person and their caregiver are willing and able, in the doctor's opinion, to follow all trial requirements throughout the study.
• The person has a confirmed diagnosis of Autism Spectrum Disorder (ASD) according to recognised medical guidelines, verified using a specific standardised assessment tool called the ADOS-2, conducted within the past 2 years by a qualified assessor (alternative confirmation methods may apply in special circumstances — confirm with trial site).
• The person is rated as at least "moderately ill" on a standard clinical scale (CGI-S score of 4 or above) at both the screening and randomisation visits.
• The person has an IQ of 70 or above, measured using a specific standardised intelligence test (WASI-II), either at screening or within the past year.
• All medications or other treatments for ASD-related symptoms (including supplements, probiotics, speech therapy, and psychosocial support) have been at a stable dose and routine for at least 4 weeks before screening and randomisation, and the person and/or caregiver are willing to keep these stable throughout the trial.
• The person is able to swallow the trial medication, which is provided as a liquid.
• The person and/or their parent(s) or legal guardian are willing to allow relevant authorities to be notified of trial participation, if required by local law.
• The person and/or their parent(s) or legal guardian are willing to allow the person's regular doctor or specialist (if different from the trial doctor) to be informed of their participation in the trial.

Who may not be able to join:

• The person currently has a diagnosis of bipolar disorder, psychosis, schizophrenia, schizoaffective disorder, or major depression (those with depression that is currently in remission may still be considered).
• The person has another diagnosis, other than ASD, that is considered more prominent in their current presentation — for example, ADHD.
• The person has a progressive neurological condition (a brain or nervous system condition that worsens over time).
• The person has had seizures in the past 24 weeks.
• The person's anti-seizure medication has been changed in the past 12 weeks.
• The person is currently taking more than 2 anti-epileptic (anti-seizure) medications.
• The person is currently taking any of the following medications: sirolimus, everolimus, temsirolimus, or tacrolimus.
• The person is currently taking clobazam.
• The person is currently taking omeprazole, lansoprazole, tolbutamide, or warfarin.
• The person is currently taking repaglinide, pioglitazone, rosiglitazone, montelukast, bupropion, or efavirenz.
• The person is currently using, or has used in the past 12 weeks, recreational or medicinal cannabis or any cannabinoid-based medication (including Sativex® or Epidiolex®), and is not willing to avoid these for the entire duration of the trial.
• The person has a known or suspected allergy or sensitivity to cannabinoids or any ingredient in the trial medication, such as sesame oil.
• The person has moderately impaired liver function, based on specific blood test results at screening (confirm with trial site for details).
• The person is male, has gone through puberty, and is not permanently sterile, unless willing to use a condom or remain sexually abstinent during the trial and for 12 weeks after it ends.
• The person is female and able to become pregnant, unless willing to use a highly effective method of contraception (such as hormonal contraception or an intrauterine device) during the trial and for 12 weeks after it ends.
• The person is female and is currently pregnant, breastfeeding, or planning to become pregnant during the trial or within 12 weeks after it ends.
• The person has taken part in another clinical trial involving an investigational medication within the past 12 weeks.
• The person has had brain surgery or a traumatic brain injury within the past year.
• The person has another significant illness or condition that, in the investigator's opinion, could affect their safety, their ability to participate, or the results of the trial.
• The person has physical examination findings that the investigator believes could put them at risk if they were to participate.
• The person has any history of suicidal behaviour (at any point in their life), or has had certain types of suicidal thoughts in the past 4 weeks or at the time of screening or randomisation, as assessed using a specific standardised scale (C-SSRS).
• The person has donated blood in the past 12 weeks and is not willing to avoid donating blood for the duration of the trial.
• The person has a known or suspected history of alcohol or substance misuse, or returns a positive drug test at screening that cannot be explained by a known current medication.
• The person has previously been enrolled in this same trial.
• The person plans to travel outside their country of residence during the trial, unless it has been confirmed that the trial medication is permitted in the destination country or region.

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