Brief Summary:
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.
Condition or disease
Intervention/treatment
Phase
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Drug: CannTrust CBD Oil (capsule)
Drug: Placebo (capsule)
Phase 3
Study Type :
Interventional
(Clinical Trial)
Estimated
Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Estimated Study Start Date :
December 2018
Estimated Primary Completion Date :
December 2020
Estimated Study Completion Date :
January 2021
