EMERALD TRIAL Open-Label Extension Study (EMERALD OLE)
Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Australia
Gold Coast Hospital and Health Service
Gold Coast
Time Frame
Start Date: 2021-05-17
Completion Date: 2024-01
Participants
Target number of participants: 7
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Bod Australia
Leads: Gold Coast Hospital and Health Service