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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03690791




Registration number
NCT03690791
Ethics application status
Date submitted
13/09/2018
Date registered
1/10/2018
Date last updated
4/02/2019

Titles & IDs
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 (CannTrust CBD Oil) in Slowing the Disease Progression in Amyotrophic Lateral Sclerosis or Motor Neurone Disease Patients
Secondary ID [1] 0 0
GCMR0001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Amyotrophic Lateral Sclerosis 0 0
Motor Neuron Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Neurodegenerative diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CannTrust CBD Oil (capsule)
Treatment: Drugs - Placebo (capsule)

Active Comparator: CannTrust CBD Oil (capsule) -

Placebo Comparator: Placebo -


Treatment: Drugs: CannTrust CBD Oil (capsule)
25 mg of CBD: <2mg of THC The cannabis oil will be extracted from a hybrid cannabis plant diluted into medium-chain-triglyceride (MCT) oil. It will be formulated in 25mg of CBD delayed release (DR) capsules.

Treatment: Drugs: Placebo (capsule)
Placebo will contain only MCT oil.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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] - Change from baseline in ALS functional rating total scores on the ALSFRS-R at 24 weeks. Total score ranges from 0 to 48. Higher value represents better outcome.
Timepoint [1] 0 0
Baseline to Day 180
Primary outcome [2] 0 0
Difference in mean Forced Vital Capacity (FVC) volume between groups at end of treatment [efficacy] - Change from baseline in Forced Vital Capacity volume on the Lung Function Test at 24 weeks
Timepoint [2] 0 0
Baseline to Day 180
Secondary outcome [1] 0 0
Nature and number of adverse events [safety and tolerability] - Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 at 24 weeks
Timepoint [1] 0 0
Baseline to Day 180
Secondary outcome [2] 0 0
Difference in mean Numeric Rating Scale for spasticity total score between groups at end of treatment (Scores 0-100) - Change from baseline in spasticity total score on the Numeric Rating Scale for spasticity at 24 weeks. Total score ranges from 0 to 100. Higher values represent better outcome.
Timepoint [2] 0 0
Baseline to Day 180
Secondary outcome [3] 0 0
Difference in mean Numeric Rating Scale for pain total score between groups at end of treatment (Total score min:1-max:100) - Change from baseline in pain total score on the Numeric Rating Scale for pain at 24 weeks. Total score ranges from 0 to 100. Higher value represents better outcome.
Timepoint [3] 0 0
Baseline to Day 180
Secondary outcome [4] 0 0
Difference in mean Percentage of Total Weight Loss score between groups at end of treatment (Percentage score min: 0- max: 100) - Change from baseline in weight loss on the Percentage of Total Weight Loss at 24 weeks. Percentage ranges from 0 to 100. Higher value represents better outcome.
Timepoint [4] 0 0
Baseline to Day 180
Secondary outcome [5] 0 0
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) - Change from baseline in quality of life total score on the ALS Specific Quality of Life- Revised (ALSSQOL-R) score at 24 weeks. Total score ranges from 0 to 460. Higher score represent better outcome.
Timepoint [5] 0 0
Baseline to Day 180

Eligibility
Key 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 25-75 years old

5. Onset of first symptom within the last 2 years

6. Forced Vital Capacity (FVC) of at least 70% on baseline
Minimum age
25 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Gold Coast Hospital and Health Service - Gold Coast
Recruitment postcode(s) [1] 0 0
4215 - Gold Coast

Funding & Sponsors
Primary sponsor type
Other
Name
Gold Coast Hospital and Health Service
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
CannTrust Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03690791
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Arman Sabet, MD
Address 0 0
Country 0 0
Phone 0 0
+61 1300 744 284
Fax 0 0
Email 0 0
Arman.Sabet@health.qld.gov.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03690791