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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04997954




Registration number
NCT04997954
Ethics application status
Date submitted
26/07/2021
Date registered
10/08/2021
Date last updated
3/04/2023

Titles & IDs
Public title
EMERALD TRIAL Open Label Extension Study
Scientific title
EMERALD TRIAL Open-Label Extension Study (EMERALD OLE)
Secondary ID [1] 0 0
GCMR0001-OLE
Universal Trial Number (UTN)
Trial acronym
EMERALD-OLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Amyotrophic Lateral Sclerosis 0 0
Cannabis 0 0
CBD 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

Experimental: MediCabilis CBD Oil - MediCabilis CBD Oil to be taken no more than 7ml/day orally based from participants' individual 14 day titration period completed at the beginning of the trial. The frequency of the drug intake can range between once and three times a day depending on the outcome of the 14 day titration period. Titration period allows participants to gradually increase study drug intake in order to find appropriate dose for participants without or with minimal undesired side effects. The treatment will last no more than 6 months.


Treatment: Drugs: MediCabilis CBD oil
The investigational product (MediCabilis 5% (50mg/ml) CBD Oil) will be supplied by BOD Australia, an Australian licensed manufacturer of medical grade cannabis.
The main components of MediCabilis 5% (50 mg/mL) CBD extract in MCT Oil are:
Cannabis sativa L. dry extract
Medium chain triglycerides (Ph Eur 0868) which are added in order to adjust the active constituent (cannabidiol) to the target content.
Each mL of MediCabilis provides:
50 mg of Cannabidiol (CBD+CBDA)
Less than 2 mg tetrahydrocannabinol (THC)
Non-active ingredient: Medium Chain Triglycerides (MCT) oil sourced from coconut
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment related adverse events [safety and tolerability].
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
To evaluate the long-term effects of MediCabilis CBD Oil on the functional status of MND patients using Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
- Diagnosed with ALS/MND, either 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, 25-80 years old

- Randomised into the EMERALD trial
Minimum age
25 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants who are bedridden

- 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 AST 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
except MediCabilis CBD Oil

- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
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
17/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2024
Actual
Sample size
Target
Accrual to date
Final
7
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
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
EMERALD OLE trial is an open-label extension of the EMERALD trial. Long term tolerability and
safety of the MediCabilis CBD oil has not been extensively studied. EMERALD OLE aims to
establish data on the prolonged used of the study drug product.

All participants who completed the EMERALD trial will be offered to enter EMERALD OLE.
Participants will be taking the active drug MediCabilis CBD oil for 6 months.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04997954
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries