Clinical Trial Details

An Open Label Observational Study of Safety and Efficacy of a Pharmaceutical grade Cannabis Medicine (MediCabilis™-CBD extract Oil) in Patients undergoing Medicinal Cannabis Therapy for Different Indications

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Trial Information

Broad Health Condition Anaesthesiology
Neurological
Mental Health
Neurological
Neurological
Neurological
Neurological
Oral and Gastrointestinal

Specific Health ConditionPain management
Epilepsy
Other mental health disorders
Other neurological disorders
Parkinson's disease
Dementias
Multiple sclerosis
Inflammatory bowel disease

Trial Focus

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Anticipated date of first participant enrolment20/07/2020

Anticipated date of last participant enrolment20/07/2020

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Trial summary

This study is a multicenter, open label, longitudinal observational study aiming to assess the safety, tolerability and efficacy of MediCabilis™ when used at the prescribed dose by physicians for different indications using data reported by patients during treatment. 
Eligibility

Key inclusion criteria

Participants will be any patient who has been prescribed MediCabilis through the Special Access Scheme B or by an authorised prescriber. 
Participants may be taking MediCabilis in any dose, form, duration and free
quency, and for any condition. 
Patients of any gender who is equal or greater than 18 years may participate.
Prospective patients that understand the informed consent process and to give informed consent to participate in the study. 
Diagnosis of their condition/disease confirmed by patient’s GP or specialist.

Prospective participants agree to abstain from using illicit cannabis products for the duration of their participation in the study.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Any severe cognitive, intellectual disability, medical or psychiatric condition that impairs the participant’s ability to provide informed consent.
Patients who are using illicit forms of cannabis.
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Bod Australia
Primary Sponsor Address: Level 1, 377 New South Head Road DOUBLE BAY NSW 2028
Primary Sponsor Country: Australia

Trial IDACTRN12620000741987

Contact person for information and recruitmentDr
Adele Hosseini
Bod Australia Level 1, 377 New South Head Road Double Bay NSW 2038 NSW
+61 2 9199 5080

Further information iconadele.hosseini@bodaustralia.com
Australia