Study Purpose:
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 Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis , Motor Neuron Disease
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
MediCabilis CBD Oil, Placebo Oil
Placebo:
Yes
Phase:
Phase 3
Study Chair(s)/Principal Investigator(s):
N/A
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Gold Coast Hospital and Health Service
Gold Coast, Queensland, Australia
Study Sponsor:
Gold Coast Hospital and Health Service
Estimated Enrollment:
17
Estimated Study Start Date:
01 / 09 / 2019
Estimated Study Completion Date:
01 / 30 / 2024
Posting Last Modified Date:
04 / 03 / 2023
Date Study Added to neals.org:
10 / 01 / 2018
Minimum Age:
25 Years
Maximum Age:
80 Years
Can participants use Riluzole?
Yes
Inclusion Criteria:1. Affected by ALS/MND, either of definite or probable according to the El Escorial revised criteria
2. Can provide written informed consent
3. Able and willing to comply with all study requirement
4. Male or female, ages 25-80 years old
5. Onset of first symptom within the last 2 years
6. Forced Vital Capacity (FVC) of at least 60% on baseline
Exclusion Criteria:
1. Participants who are bedridden
2. Have used or taken cannabis or cannabinoid-based medications within 30 days of study entry
3. History of any psychiatric disorder other than depression associated with their underlying condition including immediate family history of schizophrenia
4. Heavy consumption of alcohol or use of illicit drug
5. Hypersensitivity to cannabinoids or any of the excipients
6. Any of the following: eGFR <30 mL/min/1.73m2, ejection fraction <35%, or ASL and ALT >5 X ULN
7. Unwillingness of a female participant of child bearing potential, or their partner, to use effective contraception during the study and 30 days thereafter
8. Pregnant, lactating mother or female participant planning pregnancy during the course of the study and for 30 days thereafter
9. Received any investigational drug or medical device within 30 days prior randomisation
10. 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
11. Inability to cooperate with the study procedures
12. Unwilling to stop driving vehicle or operating dangerous machinery whilst on study drug.
13. Close affiliation with the study team, e.g. close relative of the investigator
Gold Coast Hospital and Health Service
Gold Coast, Queensland
4215
Australia