EMERALD TRIAL Open Label Extension Study

NCT ID: NCT04997954

Last Updated: 2023-04-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-17
• Study Completion Date: 2024-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MediCabilis CBD oil

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bod Australia

INDUSTRY

Sponsor Role: collaborator

Gold Coast Hospital and Health Service

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gold Coast Hospital and Health Service

Gold Coast, Queensland, Australia

Countries

Australia

Other Identifiers

GCMR0001-OLE

Identifier Type: -

Identifier Source: org_study_id