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EMERALD TRIAL Open Label Extension Study (EMERALD-OLE)

Primary Purpose

Amyotrophic Lateral Sclerosis, Cannabis, CBD

Status

Active

Phase

Phase 4

Locations

Australia

Study Type

Interventional

Intervention

MediCabilis CBD oil

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Gold Coast Hospital and Health Service

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MediCabilis CBD Oil

Arm Description

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.

Outcomes

Primary Outcome Measures

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

AE collection

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04997954

First Posted

July 26, 2021

Last Updated

March 30, 2023

Sponsor

Gold Coast Hospital and Health Service

Collaborators

Bod Australia

1. Study Identification

Unique Protocol Identification Number

NCT04997954

Brief Title

EMERALD TRIAL Open Label Extension Study

Acronym

EMERALD-OLE

Official Title

EMERALD TRIAL Open-Label Extension Study (EMERALD OLE)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 17, 2021 (Actual)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gold Coast Hospital and Health Service

Collaborators

Bod Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis, Cannabis, CBD, Motor Neuron Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MediCabilis CBD Oil

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

MediCabilis CBD oil

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

AE collection

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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)

Description

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.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Gold Coast Hospital and Health Service

City

Gold Coast

State/Province

Queensland

ZIP/Postal Code

4215

Country

Australia

12. IPD Sharing Statement

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EMERALD TRIAL Open Label Extension Study

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