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EMERALD TRIAL Open Label Extension Study (EMERALD-OLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04997954
Recruitment Status : Not yet recruiting
First Posted : August 10, 2021
Last Update Posted : August 10, 2021
Sponsor:
Collaborator:
Bod Australia
Information provided by (Responsible Party):
Gold Coast Hospital and Health Service

Study Description
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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.


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Cannabis CBD Motor Neuron Disease Drug: MediCabilis CBD oil Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EMERALD TRIAL Open-Label Extension Study (EMERALD OLE)
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: 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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of treatment related adverse events [safety and tolerability]. [ Time Frame: 6 months ]
    AE collection


Secondary Outcome Measures :
  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) [ Time Frame: 6 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04997954


Contacts
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Contact: Berzenn Urbi, RN +61756876476 berzenn.urbi@health.qld.gov.au
Contact: Arman Sabet, MD Arman.Sabet@health.qld.gov.au

Sponsors and Collaborators
Gold Coast Hospital and Health Service
Bod Australia
More Information
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Responsible Party: Gold Coast Hospital and Health Service
ClinicalTrials.gov Identifier: NCT04997954    
Other Study ID Numbers: GCMR0001-OLE
First Posted: August 10, 2021    Key Record Dates
Last Update Posted: August 10, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
 Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases