This is a randomised double-blind, single-centre phase 3 study to assess the safety, tolerability and efficacy of Cannabis Based Medicine Extract (MediCabilis CBD by BOD Au) in slowing the progression of disease in motor neurone disease patients. The study team will treat 30 patients over a period of six months to evaluate the protective mechanisms of cannabis that could help to delay disease progression.
People with MND can participate in this trial at the Gold Coast University Hospital, QLD. The study will include comprehensive neurological and diagnostic assessments at no cost to the participant. Participants will be assigned by chance (a process called randomisation) to receive either medicinal cannabis or placebo. Treatment will continue for 180 days, with a commitment to taking the medication every day for this period. Participants will be seen every 3 months in the research clinic, located at the Gold Coast University Hospital. Monthly telephone calls will occur between these visits. This study will not interfere with any other medication you are taking at the time and you will remain under the care of your physicians.
To be considered for inclusion in the study you need to have a probable or definite MND diagnosis, be between the ages of 25 and 80 and have symptom onset within two years. Exclusion criteria are listed here.
A possible treatment resulting from this study is years away. This research will provide preliminary data on whether medicinal cannabis has an effect on the progression of motor neurone disease. Research is ongoing and there are currently no completed studies that have looked at cannabis as a treatment to delay MND progression and prolong survival in humans.