A Randomised, Double-blind, Single-centre Study on the Safety, Tolerability and Efficacy of Cannabis Based Medicine Extract (CannTrust CBD Oil) in Slowing the Disease Progression in Amyotrophic Lateral Sclerosis or Motor Neurone Disease Patients
Study Purpose:
This is a randomised, double-blind, placebo controlled study on a cannabis-based medicine extract (CannTrust CBD Oil), in patients with Amyotrophic Lateral Sclerosis or Motor Neurone Disease. Participants will be randomised in a 1:1 ratio to receive CannTrust CBD Oil or placebo (both in capsules). 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.
Disease:
Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALSStudy Type:
Interventional TrialStudy Category:
Drug TrialStudy Status:
EnrollingPhase:
Phase IIIStudy Chair(s)/Principal Investigator(s):
Clinicaltrials.gov ID (11 digit #):
NCT03690791Neals Affiliated?
NoCoordinating Center Contact Information
Gold Coast Hospital and Health ServiceArman Sabet, MD / .(JavaScript must be enabled to view this email address) / +61 1300 744 284
Berzenn Urbi, RN / .(JavaScript must be enabled to view this email address) / +61 1300 744 284
Gold Coast, Queensland Australia