A Randomized Double Blind Study of Cannabis on Dystonia and Spasticity in Pediatric Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changing in Spasticity and Dystonia grades using Modified Ashworth Scale, Barry Albright Dystonia Scale and Patient's subjective report
研究概览
简要总结
A clinical trial is planned to study the effects of cannabis on dystonia and spasticity in children with neurological diseases. The clinical trial will include 40 children divided into two groups: children with spasticity and dystonia due to cerebral palsy, and children with spasticity and dystonia due to genetic neurodegenerative diseases. Each group will be randomly divided into two arms and will receive Avidekel cannabis oil 6-to-1 ratio of CBD to THC or enriched Avidekel cannabis oil 20-to-1 ratio of CBD to THC. During the study, various variables will be collected including: medication intake, spasticity, dystonia score, pain scale, restlessness scale, quality of life measures, safety tests, side effects, and an addiction test. The investigators hypothesize that cannabis consumption will reduce dystonia and spasticity in children with motor disability related to genetic neurodegenerative diseases and cerebral palsy and as a result improve motor function, non-motor functions and quality of life.
详细描述
The purpose of this study is to examine the effect of two cannabis oils containing the main cannabinoid Δ9 -THC and CBD ratio of 1 to 6 and 1 to 20 (respectively), on spastic movement disorder and dystonia.
40 children will be enrolled in this study and will be divided into 2 groups:
- Children with spasticity and dystonia due to cerebral palsy
- Children with spasticity and dystonia due to genetic neurodegenerative diseases
Each group will be randomly divided into two groups:
I. Active comparator: 6-to-1 ratio of CBD to THC oil II. Active comparator: 20-to-1 ratio of CBD to THC oil
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ages one to 18 years old with a diagnosis of cerebral palsy or motor disability; spastic in light of neurodegenerative disease
- •Standard ECG test results and stable health condition
排除标准
- •Participants that have been diagnosed with psychosis.
- •Abnormal ECG test results
研究组 & 干预措施
1 Avidekel
Patients with spasticity and dystonia related to genetic neurodegenerative disease will consume Avidekel oil (6-to-1 ratio of CBD to THC)
干预措施: Avidekel oil (Drug)
2 Enriched Avidekel
Patients with spasticity and dystonia related to genetic neurodegenerative disease will consume Enriched Avidekel oil (20-to-1 ratio of CBD to THC)
干预措施: Enriched Avidekel oil (Drug)
3 Avidekel
Patients with spasticity and dystonia due to cerebral palsy will consume Avidekel oil (6-to-1 ratio of CBD to THC)
干预措施: Avidekel oil (Drug)
4 Enriched Avidekel
Patients with spasticity and dystonia due to cerebral palsy will consume Enriched Avidekel oil (20-to-1 ratio of CBD to THC)
干预措施: Enriched Avidekel oil (Drug)
结局指标
主要结局
Changing in Spasticity and Dystonia grades using Modified Ashworth Scale, Barry Albright Dystonia Scale and Patient's subjective report
时间窗: Approximately 2 years
次要结局
- Quality Of Life Scores on the Visual Analog Scale and CPCHILD questionnaire(Approximately 2 years)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Approximately 2 years)
- Comparing the scores receive from the different scales in both groups to determine the most effective cannabis oil - a ratio of 1 to 6 or 1 to 20 of Δ9 -THC to CBD.(Approximately 2 years)
研究者
Luba Blumkin
Dr. Luba Blumkin
Wolfson Medical Center