Observational Study of two low dose medicinal cannabis oral oils to treat Autism associated behaviours.
- Conditions
- Autism Spectrum Disorder (ASD)Mental Health - Autistic spectrum disorders
- Registration Number
- ACTRN12621000370808
- Lead Sponsor
- Zelira Therapeutics Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 150
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
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method