MediCabilis CBD Oil
50 mg of CBD: \<2mg of THC in one ml. The cannabis oil consists of CBD extract in MCT oil.
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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2023-04-03
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Research network
Interventions
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.
Eligibility
primary outcomes
Time frame: Baseline to Day 180
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
Change from baseline in Forced Vital Capacity volume on the Lung Function Test at 24 weeks
secondary outcomes
Time frame: Baseline to Day 180
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 at 24 weeks
Time frame: Baseline to Day 180
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
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
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
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.
other outcomes
Time frame: Baseline to Day 180
Change from baseline in quality of life total score on the ALS Specific Quality of Life- Revised (ALSSQOL-R) total score at 24 weeks. Total score ranges from 0 to 100. Higher score represent better outcome.
Publications