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Clinical Trial Details

Observational Study of two low dose medicinal cannabis oral oils to treat Autism associated behaviours.

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Trial Information

Broad Health Condition Mental Health

Specific Health ConditionAutistic spectrum disorders

Trial Focus

Recruitment statusNot yet recruiting

Recruitment Details
Recruitment State
NSW,WA,VIC

Hospital
Emerald Clinics Ltd - West Leederville - West Leederville


Postcode
6007 - West Leederville

Anticipated date of first participant enrolment15/04/2021

Anticipated date of last participant enrolment15/04/2021

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Trial 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. 
Eligibility

Key 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

Minimum age6 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key 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.
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Zelira Therapeutics Ltd
Primary Sponsor Address: Level 26, 140 St Georges Terrace Perth WA 6000
Primary Sponsor Country: Australia

Trial IDACTRN12621000370808

Contact person for information and recruitmentDr
Alistair Vickery
Emerald Clinics Ltd Suite 9, Level 1 2 McCourt St West Leederville WA 6007
+61 08 6559 2829

Further information iconinfo@emeraldclinics.com.au
Australia