EMERALD TRIAL Open-Label Extension Study (EMERALD OLE)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Incidence of treatment related adverse events [safety and tolerability].
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Participants who are bedridden
- •History of any psychiatric disorder other than depression associated with their underlying condition including immediate family history of schizophrenia
- •Heavy consumption of alcohol or use of illicit drug
- •Hypersensitivity to cannabinoids or any of the excipients
- •Any of the following: eGFR <30 mL/min/1.73m2, ejection fraction <35%, or AST and ALT >5 X ULN
- •Unwillingness of a female participant of child-bearing potential, or their partner, to use effective contraception during the study and 30 days thereafter
- •Pregnant, lactating mother or female participant planning pregnancy during the course of the study and for 30 days thereafter
- •Received any investigational drug or medical device within 30 days prior randomisation except MediCabilis CBD Oil
- •Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
- •Inability to cooperate with the study procedures
- •Unwilling to stop driving vehicle or operating dangerous machinery whilst on study drug.
- •Close affiliation with the study team, e.g. close relative of the investigator
研究组 & 干预措施
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.
干预措施: MediCabilis CBD oil (Drug)
结局指标
主要结局
Incidence of treatment related adverse events [safety and tolerability].
时间窗: 6 months
AE collection
次要结局
- 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)(6 months)