Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gold Coast Hospital and Health Service
With
Bod Australia
Age
25–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosed with ALS/MND, either definite or probable according to the El Escorial revised criteria
Can provide written informed consent
Able and willing to comply with all study requirement
Male or female, 25-80 years old
Randomised into the EMERALD trial
You may not be if
Participants who are bedridden
History of any psychiatric disorder other than depression associated with their underlying condition including immediate family history of schizophrenia
Heavy consumption of alcohol or use of illicit drug
Hypersensitivity to cannabinoids or any of the excipients
Any of the following: eGFR \<30 mL/min/1.73m2, ejection fraction \<35%, or AST and ALT \>5 X ULN
Unwillingness of a female participant of child-bearing potential, or their partner, to use effective contraception during the study and 30 days thereafter
Pregnant, lactating mother or female participant planning pregnancy during the course of the study and for 30 days thereafter
Received any investigational drug or medical device within 30 days prior randomisation except MediCabilis CBD Oil
Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
Inability to cooperate with the study procedures
Unwilling to stop driving vehicle or operating dangerous machinery whilst on study drug.
Close affiliation with the study team, e.g. close relative of the investigator
