None listed
Conditions
Brief summary
This is a 17 to 57-week open-label study to evaluate the safety and efficacy of full-spectrum medicinal cannabis plant extract containing only 0.08% THC (FEN164) in children with Autism Spectrum Disorder (ASD). The purpose of this study is to determine how safe and effective FEN164 is in patients with ASD when treated with 20mg/kg/day for an 8 week period. Participants will commence treatment with a daily dose of 5mg/kg of FEN164. This will gradually increase over a four-week period until the maximum tolerated daily dose or 20mg/kg per day is achieved (Up-titration phase). Participants will continue to receive their respective maximum dose for eight (8) weeks (Treatment phase). Participants who wish to continue receiving their maximum tolerated dose beyond the 8-week Treatment phase may do so for up to fifty-three (53) weeks (Extension phase). At the end of the Treatment or Extension phase, participants will be gradually decreased by 5 mg/kg for a period of 4 weeks until the end of their participation (Down-titration phase). Safety will be measured and monitored by performing full blood examinations and liver and renal function tests throughout the study. Efficacy will be measured and monitored by performing participant- and psychologist- led questionnaires specific to measuring changes in the behaviour of patients with ASD.
Interventions
Full-spectrum medicinal cannabis plant extract with 0.08% THC (FEN164).
FEN164 is an oil that will be administered orally over the course of the study.
The study involves the following phases:
• Baseline/Up-titration phase: Children will receive a baseline dose of 5mg/kg/day of FEN164 that will be increased weekly by 5mg/kg for a period of 4 weeks until the maximum tolerated dose or 20mg/kg is achieved.
• Treatment phase: Children will receive the maximum tolerated dose daily or 20mg/kg/day f
Full-spectrum medicinal cannabis plant extract with 0.08% THC (FEN164). FEN164 is an oil that will be administered orally over the course of the study. The study involves the following phases: • Baseline/Up-titration phase: Children will receive a baseline dose of 5mg/kg/day of FEN164 that will be increased weekly by 5mg/kg for a period of 4 weeks until the maximum tolerated dose or 20mg/kg is achieved. • Treatment phase: Children will receive the maximum tolerated dose daily or 20mg/kg/day for either an 8-week period or they may choose to extend this up to 53 weeks (Extension phase). • Down-titration phase: At the end of the Treatment Phase, children will receive a dosage that will be gradually decreased by 5mg/kg/week for a period of 4 weeks until the end of the study. • Extension phase: Participants who choose to continue receiving the maximum tolerated dose beyond the set 8 weeks may do so for up to 53 weeks. They will undergo the Down-titration phase at the end of their Extension phase.
Sponsors
Fenix Innovation Group
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
8 Years to 17 Years
Healthy volunteers
No
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 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 excipients • Participant has 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. This criterion can only be confirmed once the laboratory results are available; participants enrolled into the trial who are later found to meet this criterion must be screen-failed. • 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 with 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. • Participant had brain surgery or traumatic brain injury within 1 year of screening. • Participant has 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 jeopardize 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 randomization • Participant has donated blood during the past 12 weeks and is unwilling to abstain from donation of blood during the trial. • Participant has 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). • Participant has previously been enrolled into this trial. • Participant has plans to travel outside their country of residence during the trial, unless the participant has confirmation that the product is permitted in the destination country/state
Outcome results
None listed