EMERALD TRIAL Open Label Extension Study (EMERALD-OLE)
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|ClinicalTrials.gov Identifier: NCT04997954|
Recruitment Status : Not yet recruiting
First Posted : August 10, 2021
Last Update Posted : August 10, 2021
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|
|Amyotrophic Lateral Sclerosis Cannabis CBD Motor Neuron Disease||Drug: MediCabilis CBD oil||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||EMERALD TRIAL Open-Label Extension Study (EMERALD OLE)|
|Estimated Study Start Date :||October 2021|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||July 2023|
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:
Each mL of MediCabilis provides:
- Incidence of treatment related adverse events [safety and tolerability]. [ Time Frame: 6 months ]AE collection
- 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) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04997954
|Contact: Berzenn Urbi, RNfirstname.lastname@example.org|
|Contact: Arman Sabet, MD||Arman.Sabet@health.qld.gov.au|