Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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Trial details imported from ClinicalTrials.gov

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

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
NA
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)

Funding & Sponsors
Primary sponsor type
Government body
Name
Gold Coast Hospital and Health Service
Address
Country

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/study/NCT04997954
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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/NCT04997954