Safety and Efficacy of Oral Full-Spectrum Medicinal Cannabis Plant Extract in Children With Autis… (NCT05516407) | Clinical Trial Compass
UnknownPhase 1/2
Safety and Efficacy of Oral Full-Spectrum Medicinal Cannabis Plant Extract in Children With Autism Spectrum Disorder.
Australia18 participantsStarted 2021-04-01
Plain-language summary
This is a 20-week open-label study to evaluate the safety and efficacy of full-spectrum medicinal cannabis plant extract \< 0.08% THC (FEN164) in children with Autism Spectrum Disorder.
Who can participate
Age range8 Years – 17 Years
SexALL
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Inclusion Criteria:
* Participant is aged 8 years to 17 years (inclusive)
* Participant is at a healthy weight at the discretion of the Principal Investigator.
* Parents or caregivers can give informed consent for participation in the trial with assent from individuals with autism.
* Participants can comply with trial requirements.
* According the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria the participant has a diagnosis of Level 2 or 3 Autism Spectrum Disorder (ASD) confirmed by Autism Diagnostic Observational Schedule (ADOS-2) criteria
* All treatments including medications and therapies for ASD related symptoms must have been stable for 4 weeks before enrolment and for the duration of the trial wherever possible.
* Participants must be able to swallow liquid.
* Consent giver must be able to understand the requirements of the study.
Exclusion Criteria:
* Current diagnosis of bipolar disorder, psychosis, schizophrenia, schizoaffective disorder, or active major depression
* Has a diagnosis other than ASD that dominates the clinical presentation (e.g., Attention Deficit Hyperactivity Disorder \[ADHD\])
* Has a degenerative condition
* Changes in anticonvulsive therapy within the last 12 weeks
* Taking omeprazole, lansoprazole, tolbutamide, warfarin, sirolimus, everolimus, temsirolimus, tacrolimus, clobazam, repaglinide, pioglitazone, rosiglitazone, montelukast, bupropion, or efavirenz
* Currently using or has used recreational or med…
What they're measuring
1
Clinical Global Impression Scale - Improvement (CGI-I)