None listed
Conditions
Brief summary
This is an open label, observational study enrolling people (including children and adolescents (from 6 to 18 years) and adults) with ASD presenting with behavioural symptoms (including behaviour (aggressiveness, hyperactivity, irritability), social and emotional responsiveness, and communication skills) that receive medicinal cannabis as prescribed per standard practice. Patients will receive medicinal cannabis products HOPE 1 and/or HOPE 2 as per standard of care recommendations by their treating doctors. Patients will be assessed for their disease and safety according to standard practice. Each patient will be observed for a period of six months from the first visit. Observation will only be on those patients that have been prescribed HOPE 1 and/or HOPE 2.
Interventions
This is an open label study enrolling people (including children and adolescents (from 6 to 18 years) and adults) with Autism Spectrum Disorder (ASD) presenting with behavioural symptoms that receive medicinal cannabis as prescribed per standard practice. Patients who are receiving HOPE 1 and/or HOPE 2 products as part of their standard of care treatment (through the Special Access or Authorised Prescriber schemes) will be offered the option to consent to the observational study. This study prov
This is an open label study enrolling people (including children and adolescents (from 6 to 18 years) and adults) with Autism Spectrum Disorder (ASD) presenting with behavioural symptoms that receive medicinal cannabis as prescribed per standard practice. Patients who are receiving HOPE 1 and/or HOPE 2 products as part of their standard of care treatment (through the Special Access or Authorised Prescriber schemes) will be offered the option to consent to the observational study. This study provides the sponsor with patient data assessed for their disease and safety according to standard practice. HOPE 1 and HOPE 2 are oral oil formulations, administered twice daily at a dosage recommended by the study doctor as per their standard of care practice. Patient's may receive HOPE 1 and/or HOPE 2. It is recommended that starting doses should be low, and increased over time in 0.25ml increments or as tolerated. Each patient will be observed for a period of six months from their first visit. Visits will be completed by their treating doctor (General Practitioner), and patients will be monitored for adverse events and adherence to dosing. Each visit shall take approximately 30 minutes. Patients and/or carer as applicable will complete the following ASD related standard of care questionnaires approximately monthly or as directed by their doctor: (Aberrant Behaviour Checklist (ABC), Clinical Global Impression (CGI), Caregiver Global Impression of Change (CaGI), Sleep Disturbance Scale (SDSC), Autism Parenting Stress Index (APSI) and Insomnia Severity Index (ISI - adults only). The following assessments will be collected approximately monthly or as directed by their treating doctor: collection of vital signs and review of adverse effects. Standard of care blood tests (if required) may be collected approximately 3 monthly, or as directed by the treating doctor. Data collected from these visits will form the basis of the data analysis for the study.
Sponsors
Zelira Therapeutics Ltd
Eligibility
Sex/Gender
All
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a. Signed consent (patients and/or carer) b. Have a documented history of Autism Spectrum Disorder (including diagnosis and severity of ASD) c. Patient and caregiver must be able to return to clinic on days specified in the protocol d. Patient and caregiver must be able to adhere to all assessments as described e. Have a valid assessment of severity using the Connors Parent and School assessment or similar tool within the previous 12 months f. Have exhausted conventional therapies listed on the ARTG for ASD g. For paediatric patients only: Have trialled or are being considered for treatment with antipsychotic medications h. For paediatric patients only: Have a letter of support or referral from their treating paediatrician to trial cannabinoid therapies or be managed by Emerald Clinics. i. Planned to be administered either HOPETM 1 and/or HOPETM 2 medicinal cannabis
Exclusion criteria
j. Patient is currently using recreational or medicinal cannabis, or synthetic cannabinoid-based medications within one month prior to study entry and is unwilling to abstain for the duration of the trial.
Outcome results
None listed