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EMERALD TRIAL Open Label Extension Study

NCT04997954 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-04-03

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Bod Australia

    collaborator INDUSTRY

  • Gold Coast Hospital and Health Service

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-17
Primary Completion
2023-06-30
Completion
2024-01-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04997954 on ClinicalTrials.gov