A Randomized, Double Blind, Placebo-controlled Parallel Study of Tolerability and Efficacy of Cannabidiol (CBD) on Motor Symptoms in Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Change in Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) Scores
研究概览
简要总结
The major purpose of this study is to assess the efficacy of CBD on motor symptoms of Parkinson's Disease (PD), and secondarily to study the safety and tolerability of CBD and other efficacy, particularly regarding tremor in PD. The study has been powered to detect a clinically significant reduction in Movement Disorder Society (MDS) Unified Parkinson's Disease Rating Scale (UPDRS) Part III motor scores. This is a 1:1 parallel, double-blind, randomized controlled trial (RCT) with 60 participants. The investigators will be recruiting up to 75 participants; the goal is to have 60 participants (30 in CBD group and 30 in placebo group) complete the study. The study drug is obtained from the National Institute on Drug Abuse (NIDA).
详细描述
Persons with PD have progressive disabling tremor, slowness, stiffness, balance impairment, cognitive deficits, psychiatric symptoms, autonomic dysfunction, fatigue and insomnia. Tremor may interfere with necessary daily and work functions. The disorder affects approximately seven million people globally. The total economic cost in the US is around 23 billion dollars. In addition to economic costs, PD reduces quality of life of those affected and their caregivers.
Cognitive impairment is a common feature and ranges from delayed recall in early stages to global dementia in up to 80% at end stage. PD with dementia has been associated with reduced quality of life, shortened survival, and increased caregiver distress. Community-based studies have estimated the point prevalence for dementia in PD to be 28% and 44%.
Depression, anxiety and psychosis are also common and are particularly disabling in PD, even at the earliest stages. These symptoms have important consequences for quality of life and daily functioning, are associated with increased carer burden and risk for nursing home admission. Anxiety affects up to 40% of patients with PD, and may predate motor symptoms by several years. The most common anxiety disorders in PD are panic attacks (often during off-periods), generalized anxiety disorder, and simple and social phobias. Psychotic symptoms vary in frequency according to the definition used. If mild forms are included, these affect up to 50% of patients. Visual hallucinations are the most common type. However, hallucinations occur in all sensory domains and delusions of various types are also relatively common. The impact of psychosis is substantial in that it is associated with dementia, depression, earlier mortality, greater caregiver strain, and nursing home placement. Thus, it is crucial to treat these symptoms in order to optimize the management of PD patients.
Generally, however, current therapies are inadequate. Medications have improved the prognosis of PD, but also have problematic adverse effects.
Since treatment of PD is often unsatisfactory and since cannabis has recently become legal and readily available in Colorado, persons with PD have been trying it. Patients have heard from the internet, support groups and other sources that marijuana is helpful. Most are doing so on their own, without the supervision or even knowledge of their neurologist. In a survey conducted in the spring of 2014 in University of Colorado Hospital Movement Disorders clinic about 5% of 207 PD patients, average age 69, reported using cannabis. In another study reported that 25% of PD patients had taken cannabis in the General University Hospital in Prague. In the investigators clinics, about 30% of the PD patients have asked doctors during their clinic visits over the past 6 months about cannabis. In an anonymous web-based survey, 72% PD patients reported current or past using medical cannabis, and 48% reducing prescription medication since beginning cannabis use.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CBD Cannabis extract oral solution
Cannabidiol (CBD) Cannabis extract oral solution
干预措施: Cannabidiol (Drug)
placebo
Placebo oral solution
干预措施: Placebo (Other)
结局指标
主要结局
Change in Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) Scores
时间窗: From baseline to the end of 2.5 mg/kg/day of CBD, through 3 weeks
Movement Disorders Society-Unified Parkinson's disease rating scale(MDS UPDRS) Part III assesses the motor signs of PD. There are 33 scores based on 18 items, several with right, left or other body distribution scores.Each question is anchored with five responses that are linked to commonly accepted clinical terms: 0=normal, 1=slight, 2=mild, 3=moderate, and 4=severe. The possible change may be the scores of the total 33 scores. Scores ranges 0 -132. Higher values represent a worse outcome.
次要结局
- Change in Blood Pressure (Systolic)(Baseline; at the end of 2.5 mg/kg/day, through 3 weeks)
- Change in Liver Function Monitoring --Liver Function Test(Baseline; at the end of 2.5 mg/kg/day; and every 3-5 days at each dose level, through 3 weeks.)
- Change in Vital Signs-heart Rate(Baseline; at the end of 2.5 mg/kg/day, through 3 weeks)
- Change in Laboratory Values--hematology(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Laboratory Values--chemistry(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- The Number of Participants Wtih Treatment-related Adverse Events(Every 3-5 days at each dose level, assessed up to 3 weeks)
- Change in Vital Signs--weight(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Neurological Exam(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Wechsler Test for Adult Reading(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- The Number of Participants Wtih Liver Function Impairment Related Adverse Events(Baseline; at the end of 2.5 mg/kg/day; and every 3-5 days at each dose level, through 3 weeks.)
- Change in Physical Exam(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Electrocardiograms(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Grooved Pegboard Test(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Symbol Digit Modalities Test(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Vital Signs--temperature (Fahrenheit Degree)(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Montreal Cognitive Assessment (MoCA)(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change From Baseline for the Delayed Recall Trials Score of HVLT-R(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Bradykinesia Sub Scores in MDS UPDRS(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Paced Auditory Serial Addition Test(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Controlled Oral Word Association Test(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Anxiety Short Form Response(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Scales of Outcomes in Parkinson's Disease (SCOPA) Sleep-daytime Sleepiness(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Hopkins Verbal Learning Test-total Learning(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change From Baseline in Hopkins Verbal Learning Test-Delayed Recognition Trial(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Judgment of Line Orientation(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Semantic Verbal Fluency(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Neuropsychiatric Inventory (NPI)(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Pain Intensity 3a Short Form(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Movement Disorder Society Unified Parkinson Disease Rating Scale(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in EuroQol-5 Dimension-5 Level(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Difference in Proportion of Participants That Discontinue the Study Due to Study Drug Intolerance(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Stanford Sleepiness Scale(Pre- and 3 hours post- dose at baseline visit)
- Change in Rigidity Sub Scores in MDS UPDRS(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Axial Sub Scores in MDS UPDRS(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Bulbar Sub Scores in MDS UPDRS(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Dermatology Quality of Life Index(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Fatigue Severity Scale(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in IRLS(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Rapid Eye Movement Sleep Behavior Disorder Screening Questionnaire (RBDSQ)(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Item 2.10 in MDS UPDRS(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Depression Short Form(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Pain Interference 4a Short Form(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Unified Dyskinesia Rating Scale(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Overactive Bladder Symptom Score(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Total Scores on Items 3.17 and 3.18 in MDS-UPDRS(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Item 3.15 and 3.16 in MDS UPDRS(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Insomnia Severity Index(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in the Number of Participants With Presence of Seborrheic Dermatitis From Baseline to Final Visit.(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Difference of Plasma Interleukin 6 Level Between PD and Healthy Control Population(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Emotional and Behavioral Dyscontrol Short Form(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in the Timed UP&GO (TUG)(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Parkinson's Disease Questionnaire (PDQ-39)(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Pittsburgh Sleep Quality Index(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Non-motor Symptoms Scale for Parkinson's Disease (NMSS)(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Scales of Outcomes in Parkinson's Disease (SCOPA) - Daytime Sleep (DS) Problems.(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Modified Dysfunctional Beliefs and Attitudes About Sleep Questionnaire (DBAS-16)(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in The Columbia-Suicide Severity Rating Scale (C-SSRS)(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Scales of Outcomes in Parkinson's Disease (SCOPA) - Nighttime Sleep (NS) Problems.(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Wake After Sleep Onset(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)
- Change in Impulsive-Compulsive Disorders in Parkinson's Disease Rating Scale (QUIP-RS) - Total Scores(From baseline to the end of 2.5 mg/kg/day, assessed up to 3 weeks)