Title
Efficacy of Cannabinoids in Amyotrophic Lateral Sclerosis or Motor Neurone Disease
A Randomised, Double-blind, Single-centre Study on the Safety, Tolerability and Efficacy of Cannabis Based Medicine Extract (MediCabilis CBD Oil) in Slowing the Disease Progression in Amyotrophic Lateral Sclerosis or Motor Neurone Disease Patients
Phase
Phase 3Lead Sponsor
Griffith UniversityStudy Type
InterventionalStatus
Active, not recruitingIndication/Condition
Motor Neuron Disease Amyotrophic Lateral SclerosisIntervention/Treatment
cannabidiol ...Study Participants
17This is a randomised, double-blind, placebo controlled study on a cannabis-based medicine extract (MediCabilis CBD Oil), in patients with Amyotrophic Lateral Sclerosis or Motor Neurone Disease. Participants will be randomised in a 1:1 ratio to receive MediCabilis CBD Oil or placebo oil. The treatment duration is 6 months with one-month safety follow up. Participants will be checked every month either face to face or via telephone and will be assessed to collect data for study objectives such as ALSFRS-R, Forced Vital Capacity, pain and spasticity score, and quality of life. Thirty (30) participants will be randomised.
50 mg of CBD: <2mg of THC in one ml. The cannabis oil consists of CBD extract in MCT oil.
Placebo will contain only hemp seed oil.
Inclusion Criteria: Affected by ALS/MND, either of 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, ages 25-80 years old Onset of first symptom within the last 2 years Forced Vital Capacity (FVC) of at least 60% on baseline Exclusion Criteria: Participants who are bedridden Have used or taken cannabis or cannabinoid-based medications within 30 days of study entry 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 ASL 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 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
