| Participants |
Inclusion criteria:
male and female aged 6‐17 years weight at least 12 kg participants and their parent(s)/legal representative are willing and able to give informed consent diagnosis of ASD as per DSM‐5 criteria, confirmed by ADOS‐2 criteria (conducted within 2 years at the trial site or at screening by a qualified assessor or ADI‐R if ADOS‐2 is not available CGI‐S ≥ 4 (moderately ill) at screening and randomisation ABC‐I subscale score ≥ 15 at screening IQ ≥ 70 at screening, or measured within 1 year of screening, using Wechsler Abbreviated Scale of Intelligence Scale Second Edition (WASI‐II) all medications or interventions (including psychosocial interventions, dietary supplements, probiotics, speech therapy, etc.) for ASD‐related symptoms must have been stable for 4 weeks prior to screening and randomisation, and the patient/caregiver should be willing to maintain a stable regimen throughout the trial able to swallow the investigational medicinal product (IMP), provided as a liquid solution participant and/or parent(s)/legal representative willing to allow the responsible authorities to be notified of participation in the trial, if necessary.
Exclusion criteria
Current diagnosis of bipolar disorder, psychosis, schizophrenia, schizoaffective disorder, or major depression (participants with depression in remission may be included) diagnosis other than ASD that dominates the clinical presentation (e.g. ADHD) progressive neurological condition seizures in the past 24 weeks changes in anticonvulsive therapy within the last 12 weeks currently taking more than 2 anti‐epileptic drugs taking sirolimus, everolimus, temsirolimus, or tacrolimus; taking clobazam; taking omeprazole, lansoprazole, tolbutamide, or warfarin; taking repaglinide, pioglitazone, rosiglitazone, montelukast, bupropion, or efavirenz; currently using or has used recreational or medicinal cannabis, cannabinoid‐based medications (including Sativex®, or Epidiolex®) within the 12 weeks prior to screening and is unwilling to abstain for the duration of the trial participant has any known or suspected hypersensitivity to cannabinoids or any of the intervention drug's excipients, such as sesame oil moderately impaired hepatic function at screening, defined as serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 × upper limit of normal (ULN) or total bilirubin (TBL) > 2 × ULN participant is male and fertile (i.e. after puberty unless permanently sterile by bilateral orchidectomy) unless willing to ensure that they use male contraception (condom) or remain sexually abstinent during the trial and for 12 weeks thereafter participant is female and of childbearing potential (i.e., following menarche and until becoming postmenopausal for ≥ 12 consecutive months unless permanently sterile by hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) unless willing to ensure that they use a highly effective method of birth control (e.g., hormonal contraception, intrauterine device/hormone‐releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence) during the trial and for 12 weeks thereafter; female participant who is pregnant (positive pregnancy test), lactating or planning pregnancy during the course of the trial or within 12 weeks thereafter received an IMP within the 12 weeks prior to the screening visit brain surgery or traumatic brain injury within 1 year of screening any other significant disease or disorder which, in the opinion of the investigator, may either put the participant, other participants, or site staff at risk because of participation in the trial, may influence the result of the trial, or may affect the participant's ability to take part in the trial any abnormalities identified following a physical examination of the participant that, in the opinion of the investigator, would jeopardise the safety of the participant if they took part in the trial; any history of suicidal behaviour (lifelong) or any suicidal ideation of type 4 or 5 on the Columbia‐Suicide Severity Rating Scale (C‐SSRS) in the last 4 weeks or at screening or randomisation donated blood during the past 12 weeks and is unwilling to abstain from donation of blood during the trial any known or suspected history of alcohol or substance abuse or positive drugs of abuse test at screening (not justified by a known concurrent medication) previously been randomised into this trial participant has plans to travel outside their country of residence during the trial, unless the participant has confirmation that the IMP is permitted in the destination country/state".
Setting/location: 7 sites in the USA, and 2 sites in both Canada and the UK
Sample size: 160 participants |
| Interventions |
Intervention GWP42003‐P (100 mg/mL cannabidiol (CBD) in sesame oil with anhydrous ethanol, ethanol sweetener [sucralose], and strawberry flavouring), administered twice a day (morning and evening)
Comparator: "Oral placebo to match GWP42003‐P oral solution containing sesame oil with anhydrous ethanol, sweetener (sucralose), strawberry flavoring, and beta carotene, administered twice a day (morning and evening)". |
