EMERALD TRIAL Open Label Extension Study

Amyotrophic Lateral Sclerosis Clinical Trial

— EMERALD-OLE  

Official title:

EMERALD TRIAL Open-Label Extension Study (EMERALD OLE)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04997954
• Other study ID #: GCMR0001-OLE
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 17, 2021
• Est. completion date: January 2024

Study information

• Verified date: March 2023
• Source: Gold Coast Hospital and Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7
• Est. completion date: January 2024
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Cannabis
• CBD
• Motor Neuron Disease

Intervention

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

Locations

Country	Name	City	State
Australia	Gold Coast Hospital and Health Service	Gold Coast	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
Gold Coast Hospital and Health Service	Bod Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment related adverse events [safety and tolerability].	AE collection	6 months
Secondary	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