NCT04997954

EMERALD TRIAL Open Label Extension Study

EMERALD TRIAL Open-Label Extension Study (EMERALD OLE)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Gold Coast Hospital and Health Service · Other Government
• Sex: All
• Age: 25 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-05-17
• Primary completion: 2023-06-01
• Completion: 2024-01-01
• First posted: 2021-08-10
• Last updated: 2023-04-03

Locations

1 site across 1 country: Australia