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EMERALD-OLE: EMERALD TRIAL Open Label Extension Study

Sponsor
Gold Coast Hospital and Health Service (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04997954
Collaborator
Bod Australia (Industry)
25
Enrollment
1
Arm
21
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: MediCabilis CBD oil
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
EMERALD TRIAL Open-Label Extension Study (EMERALD OLE)
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Incidence of treatment related adverse events [safety and tolerability]. [6 months]

    AE collection

Secondary Outcome Measures

  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]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Gold Coast Hospital and Health Service
  • Bod Australia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gold Coast Hospital and Health Service
ClinicalTrials.gov Identifier:
NCT04997954
Other Study ID Numbers:
  • GCMR0001-OLE
First Posted:
Aug 10, 2021
Last Update Posted:
Aug 10, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis

Study Results

No Results Posted as of Aug 10, 2021