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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
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Scientific title
EMERALD TRIAL Open-Label Extension Study (EMERALD OLE)
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Secondary ID [1]
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GCMR0001-OLE
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Universal Trial Number (UTN)
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Trial acronym
EMERALD-OLE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Amyotrophic Lateral Sclerosis
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Cannabis
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CBD
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Motor Neuron Disease
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Condition category
Condition code
Neurological
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Neurodegenerative diseases
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of treatment related adverse events [safety and tolerability].
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Assessment method [1]
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AE collection
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Timepoint [1]
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6 months
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Secondary outcome [1]
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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)
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Assessment method [1]
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Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) scale will be used to assess this outcome. Minimum score: 0, Maximum score: 48. Higher scores mean better outcomes.
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Timepoint [1]
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6 months
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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
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Minimum age
25
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/05/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
7
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Gold Coast Hospital and Health Service - Gold Coast
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Recruitment postcode(s) [1]
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4215 - Gold Coast
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Funding & Sponsors
Primary sponsor type
Other
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Name
Gold Coast Hospital and Health Service
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Bod Australia
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04997954
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04997954
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