This 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
17
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.
Gold Coast Hospital and Health Service
Gold Coast, Queensland, Australia
Difference in mean ALS Functional Rating Scale-Revised (ALSFRS-R) total score between groups at end of treatment (Total score: min 0- max 48) [efficacy]
Change from baseline in ALS functional rating total scores on the ALSFRS-R at 24 weeks. Total score ranges from 0 to 48. Higher value represents better outcome.
Time frame: Baseline to Day 180
Difference in mean Forced Vital Capacity (FVC) volume between groups at end of treatment [efficacy]
Change from baseline in Forced Vital Capacity volume on the Lung Function Test at 24 weeks
Time frame: Baseline to Day 180
Nature and number of adverse events [safety and tolerability]
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 at 24 weeks
Time frame: Baseline to Day 180
Difference in mean Numeric Rating Scale for spasticity total score between groups at end of treatment (Scores 0-100)
Change from baseline in spasticity total score on the Numeric Rating Scale for spasticity at 24 weeks. Total score ranges from 0 to 100. Higher values represent better outcome.
Time frame: Baseline to Day 180
Difference in mean Numeric Rating Scale for pain total score between groups at end of treatment (Total score min:1-max:100)
Change from baseline in pain total score on the Numeric Rating Scale for pain at 24 weeks. Total score ranges from 0 to 100. Higher value represents better outcome.
Time frame: Baseline to Day 180
Difference in mean Percentage of Total Weight Loss score between groups at end of treatment (Percentage score min: 0- max: 100)
Change from baseline in weight loss on the Percentage of Total Weight Loss at 24 weeks. Percentage ranges from 0 to 100. Higher value represents better outcome.
Time frame: Baseline to Day 180
Difference in mean ALS Specific Quality of Life- Revised (ALSSQOL-R) total score between groups at end of treatment (Total score min:0- max:460)
Change from baseline in quality of life total score on the ALS Specific Quality of Life- Revised (ALSSQOL-R) score at 24 weeks. Total score ranges from 0 to 460. Higher score represent better outcome.
Time frame: Baseline to Day 180
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