EMERALD TRIAL Open Label Extension Study

NCT04997954 | Unknown Phase 4 DMC

• 1 other identifier: GCMR0001-OLE
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis; Cannabis; CBD; Motor Neuron Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment related adverse events [safety and tolerability].

  AE collection

  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)

  6 months

Study Arms (1)

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.

Drug: MediCabilis CBD oil

Interventions

MediCabilis CBD oil DRUG

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

MediCabilis CBD Oil

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gold Coast Hospital and Health Service: lead
• Bod Australia: collaborator

Study Sites (1)

Gold Coast Hospital and Health Service

Gold Coast, Queensland, 4215, Australia

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Marijuana Abuse; Motor Neuron Disease

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 10, 2021
• Study Start: May 17, 2021
• Primary Completion: June 1, 2023
• Study Completion: January 1, 2024
• Last Updated: April 3, 2023

Record last verified: 2023-03

Locations

AU (1)