EMERALD TRIAL Open Label Extension Study (EMERALD-OLE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Cannabis; CBD
• Intervention / Treatment: Drug: MediCabilis CBD oil

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Gold Coast, Queensland, Australia, 4215
      • Gold Coast Hospital and Health Service

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment related adverse events [safety and tolerability].	AE collection	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Collaborators and Investigators

• Sponsor: Gold Coast Hospital and Health Service
• Collaborators: Bod Australia

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: August 1, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: GCMR0001-OLE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No