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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
Titles & IDs
Public title
Efficacy of Cannabinoids in Amyotrophic Lateral Sclerosis or Motor Neurone Disease
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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
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Secondary ID [1]
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GCMR0001
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Universal Trial Number (UTN)
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Trial acronym
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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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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
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.
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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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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]
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to Day 180
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Primary outcome [2]
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Difference in mean Forced Vital Capacity (FVC) volume between groups at end of treatment [efficacy]
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Assessment method [2]
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Change from baseline in Forced Vital Capacity volume on the Lung Function Test at 24 weeks
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Timepoint [2]
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Baseline to Day 180
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Secondary outcome [1]
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Nature and number of adverse events [safety and tolerability]
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Assessment method [1]
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Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 at 24 weeks
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Timepoint [1]
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Baseline to Day 180
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Secondary outcome [2]
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Difference in mean Numeric Rating Scale for spasticity total score between groups at end of treatment (Scores 0-100)
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline to Day 180
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Secondary outcome [3]
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Difference in mean Numeric Rating Scale for pain total score between groups at end of treatment (Total score min:1-max:100)
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline to Day 180
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Secondary outcome [4]
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Difference in mean Percentage of Total Weight Loss score between groups at end of treatment (Percentage score min: 0- max: 100)
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline to Day 180
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Secondary outcome [5]
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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)
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline to Day 180
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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
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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
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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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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
9/01/2019
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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
30/01/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
17
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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
Government body
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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
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.
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Trial website
https://clinicaltrials.gov/study/NCT03690791
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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.
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Public notes
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Contacts
Principal investigator
Name
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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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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
This study will comply with the Australian Government Data Sharing Policy, the NHMRC Open Access Policy and the Clinical Trials Registration and Results Information Submission rule.
Additional data can be requested from the authors. However, the decision to disclose data is solely based from authors' discretion and funding agency.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03690791