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 ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Enrolling

Phase:

Phase III

Study Chair(s)/Principal Investigator(s):

Clinicaltrials.gov ID (11 digit #):

NCT03690791

Neals Affiliated?

Coordinating Center Contact Information

Gold Coast Hospital and Health Service
Arman 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

Full Study Summary:

Study Sponsor:

Gold Coast Hospital and Health Service

Participant Duration:

Estimated Enrollment:

Estimated Study Start Date:

01/09/2019

Estimated Study Completion Date:

01/31/2022

Posting Last Modified Date:

07/22/2020

Date Study Added to alsconsortium.org:

05/15/2019

Eligibility Criteria

Gender:
Female, Male
Minimum Age:
25
Maximum Age:
75
Min Vital Capacity (% predicted normal):
70

Time since Symptom Onset:
<24 months
Time since Diagnosis:

Can participants use Riluzole?
Yes

Inclusion Criteria:

Affected by ALS/MND, either of definite or probable according to the El Escorial revised criteria
Can provide written informed consent
Able and willing to comply with all study requirement
Male or female, ages 25-75 years old
Onset of first symptom within the last 2 years
Forced Vital Capacity (FVC) of at least 70% on baseline

Exclusion Criteria:

Participants who are bedridden
Have used or taken cannabis or cannabinoid-based medications within 30 days of study entry
History of any psychiatric disorder other than depression associated with their underlying condition including immediate family history of schizophrenia
Heavy consumption of alcohol or use of illicit drug
Hypersensitivity to cannabinoids or any of the excipients
Any of the following: eGFR <30 mL/min/1.73m2, ejection fraction <35%, or ASL and ALT >5 X ULN
Unwillingness of a female participant of child bearing potential, or their partner, to use effective contraception during the study and 30 days thereafter
Pregnant, lactating mother or female participant planning pregnancy during the course of the study and for 30 days thereafter
Received any investigational drug or medical device within 30 days prior randomisation
Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
Inability to cooperate with the study procedures
Unwilling to stop driving vehicle or operating dangerous machinery whilst on study drug.
Close affiliation with the study team, e.g. close relative of the investigator
Site Contact Information

Gold Coast Hospital and Health Service
Arman Sabet, MD / .(JavaScript must be enabled to view this email address) / +61 1300 744 284
Gold Coast, Queensland
Australia