Last reviewed · How we verify
EMERALD TRIAL Open-Label Extension Study (EMERALD OLE) (EMERALD-OLE)
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.
Details
| Lead sponsor | Gold Coast Hospital and Health Service |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 7 |
| Start date | 2021-05-17 |
| Completion | 2024-01 |
Conditions
- Amyotrophic Lateral Sclerosis
- Cannabis
- CBD
- Motor Neuron Disease
Interventions
- MediCabilis CBD oil
Primary outcomes
- Incidence of treatment related adverse events [safety and tolerability]. — 6 months
AE collection
Countries
Australia