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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03690791
Date of registration: 13/09/2018
Prospective Registration: Yes
Primary sponsor: Gold Coast Hospital and Health Service
Public title: Efficacy of Cannabinoids in Amyotrophic Lateral Sclerosis or Motor Neurone Disease
Scientific title: A Randomised, Double-blind, Single-centre Study on the Safety, Tolerability and Efficacy of Cannabis Based Medicine Extract (MediCabilis CBD Oil) in Slowing the Disease Progression in Amyotrophic Lateral Sclerosis or Motor Neurone Disease Patients
Date of first enrolment: January 9, 2019
Target sample size: 30
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03690791
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
Australia
Contacts
Name:     Arman Sabet, MD
Address: 
Telephone: +61 1300 744 284
Email: Arman.Sabet@health.qld.gov.au
Affiliation: 
Name:     Arman Sabet, MD
Address: 
Telephone: +61 1300 744 284
Email: Arman.Sabet@health.qld.gov.au
Affiliation: 
Key inclusion & exclusion criteria

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



Age minimum: 25 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Intervention(s)
Drug: MediCabilis CBD Oil
Drug: Placebo Oil
Primary Outcome(s)
Difference in mean ALS Functional Rating Scale-Revised (ALSFRS-R) total score between groups at end of treatment (Total score: min 0- max 48) [efficacy] [Time Frame: Baseline to Day 180]
Difference in mean Forced Vital Capacity (FVC) volume between groups at end of treatment [efficacy] [Time Frame: Baseline to Day 180]
Secondary Outcome(s)
Difference in mean ALS Specific Quality of Life- Revised (ALSSQOL-R) total score between groups at end of treatment (Total score min:0- max:460) [Time Frame: Baseline to Day 180]
Difference in mean Numeric Rating Scale for pain total score between groups at end of treatment (Total score min:1-max:100) [Time Frame: Baseline to Day 180]
Difference in mean Numeric Rating Scale for spasticity total score between groups at end of treatment (Scores 0-100) [Time Frame: Baseline to Day 180]
Difference in mean Percentage of Total Weight Loss score between groups at end of treatment (Percentage score min: 0- max: 100) [Time Frame: Baseline to Day 180]
Nature and number of adverse events [safety and tolerability] [Time Frame: Baseline to Day 180]
Secondary ID(s)
GCMR0001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
BOD Australia
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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