Amyotrophic Lateral SclerosisPhase 4EMERALD-OLENCT04997954
EMERALD TRIAL Open Label Extension Study
A Phase 4 study testing MediCabilis CBD oil in people with Amyotrophic Lateral Sclerosis and Cannabis, run by Gold Coast Hospital and Health Service at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Cannabis, CBD
- What is being tested?
- MediCabilis CBD oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteAustralia
- Study dates
- 17 May 2021to Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Gold Coast Hospital and Health Service
Gold Coast, Queensland, 4215
About this study
Official title: EMERALD TRIAL Open-Label Extension Study (EMERALD OLE)
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.
- Conditions
- Amyotrophic Lateral Sclerosis, Cannabis, CBD, Motor Neuron Disease
- Being tested
- MediCabilis CBD oil
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Marijuana Abuse, Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MediCabilis CBD oilDrug
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
| Study group | Role | What they receive |
|---|---|---|
| MediCabilis CBD Oil | Experimental | 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. Receives: Drug: MediCabilis CBD oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment related adverse events [safety and tolerability].
AE collection
Measured: 6 months
Secondary outcomes (1)
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)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start17 May 2021
- Primary completionJun 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gold Coast Hospital and Health Service
- Sponsor type
- Other government
- Collaborators
- Bod Australia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997954
- Sponsor's protocol ID
- GCMR0001-OLE
- Acronym
- EMERALD-OLE
- Status last verified
- Mar 2023
- First submitted
- 26 Jul 2021
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMERALD TRIAL Open-Label Extension Study (EMERALD OLE)
- ClinicalTrials.gov ID
- NCT04997954
- Acronym / sponsor ID
- EMERALD-OLE / GCMR0001-OLE
- Conditions
- Amyotrophic Lateral Sclerosis, Cannabis, CBD, Motor Neuron Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Gold Coast Hospital and Health ServiceOther government
- Collaborators
- Bod Australia
- Study start
- 17 May 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MediCabilis CBD Oil | Experimental | Drug: MediCabilis CBD oilMediCabilis 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. |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MediCabilis CBD oilThe 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 | Drug | MediCabilis CBD Oil |
Primary outcome
Incidence of treatment related adverse events [safety and tolerability].
Time frame: 6 months
AE collection
1 secondary outcome
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)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MediCabilis CBD oil in people with Amyotrophic Lateral Sclerosis and Cannabis, run by Gold Coast Hospital and Health Service at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment related adverse events [safety and tolerability]. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.