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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03690791
Ethics application status
Date submitted
13/09/2018
Date registered
1/10/2018
Date last updated
3/04/2023

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 (MediCabilis 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 - MediCabilis CBD Oil
Treatment: Drugs - Placebo Oil

Active comparator: MediCabilis CBD Oil -

Placebo comparator: Placebo Oil -


Treatment: Drugs: MediCabilis CBD Oil
50 mg of CBD: \<2mg of THC in one ml. The cannabis oil consists of CBD extract in MCT oil.

Treatment: Drugs: Placebo Oil
Placebo will contain only hemp seed 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]
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]
Timepoint [2] 0 0
Baseline to Day 180
Secondary outcome [1] 0 0
Nature and number of adverse events [safety and tolerability]
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)
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)
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)
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)
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 25-80 years old
5. Onset of first symptom within the last 2 years
6. Forced Vital Capacity (FVC) of at least 60% on baseline
Minimum age
25 Years
Maximum age
80 Years
Sex
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/01/2024
Actual
Sample size
Target
Accrual to date
Final
17
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
Government body
Name
Gold Coast Hospital and Health Service
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bod Australia
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 (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.
Trial website
https://clinicaltrials.gov/study/NCT03690791
Trial related presentations / publications
Urbi B, Broadley S, Bedlack R, Russo E, Sabet A. Study protocol for a randomised, double-blind, placebo-controlled study evaluating the Efficacy of cannabis-based Medicine Extract in slowing the disease pRogression of Amyotrophic Lateral sclerosis or motor neurone Disease: the EMERALD trial. BMJ Open. 2019 Nov 11;9(11):e029449. doi: 10.1136/bmjopen-2019-029449.
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

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