A Double-Blind, Cross-Over, Placebo- Controlled Efficacy and Tolerability Study of Oral Cannabidiol (CBD) and Tetrahydrocannabinol (THC) for Essential Tremor (ET).
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Digital Spirography
研究概览
简要总结
This is a pilot trial to evaluate the safety and efficacy of a combined oral formulation of THC and CBD in patients with Essential Tremor.
详细描述
Essential tremor (ET) is the most common neurological movement disorder, affecting up to 1% of the population and up to 5% of individuals over the age of 65. ET is characterized by often disabling tremors that occur when an individual moves. The tremors most commonly affect the hands, head, voice, and legs in order of frequency, leading to impairment in activities of daily living and morbidity. No pharmacological agent has been developed for ET, though existing agents such as propranolol and primidone are used off-label to reduce tremor amplitude. Deep brain stimulation surgery is often reserved for only individuals with the most severe tremors. Patients with ET have long reported tremor benefits with the use of cannabis, though no controlled trials have been conducted. The investigators plan to conduct the first double-blind, placebo-control clinical trial of cannabis in an oral capsule. Various validated tremor rating methods will be used to quantify tremor severity, while looking at tolerability and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ET by a Movement Disorder Neurologist
- •Stable dose of tremor medication for a period of at least 6 weeks prior to screening
- •Tremor in the arms
- •Tremor(s) is/are moderately severe (amplitude of at least 1cm)
排除标准
- •Significant non-ET related abnormal findings on neurological exam
- •Tremor at rest, or other features suggestive of Parkinson disease
- •Diagnosis of dementia
- •Pregnant or nursing
- •Childbearing potential and unable or unwilling to use contraception during course of the trial
- •On medications known to interact with the study drug
- •Current or prior history of alcohol or substance abuse
- •Recent exposure to primidone (within the past 21 days) or benzodiazepines (such as Valium, Ativan or Klonopin), ketoconazole, ritonavir, clarithromycin, rifampin, carbamazepine, St. Johns Wort, digoxin or other medications known to affect your liver enzymes (within the past 7 days).
- •Unwilling to abstain from consuming grapefruits, grapefruit juice or grapefruit containing products.
- •Taking medications such as warfarin, cyclosporine, and amphotericin B that are highly protein-bound
- •Do not wish to take a cannabis-derived agent
- •Allergy or sensitivity to sorbitol, xylitol, stevia or other natural sweeteners
- •Allergy or sensitivity to cannabis
- •Used cannabis or a cannabis-derived product (such as CBD oil) within the past 4 weeks or plan to use it during this research study.
- •Diagnosis of a psychiatric disorder (e.g., mania, bipolar depressive disorder, schizophrenia, schizoaffective disorder, or other major psychiatric disorder)
- •Current or prior history of suicidal thoughts and/or behavior
- •Active medical problem affecting the immune system, liver, gastrointestinal tract, lungs, heart, endocrine system (such as diabetes and/or thyroid), and/or a blood clotting disorder
- •Current infection
- •Reduced kidney function (GFR <60)
研究组 & 干预措施
CBD/THC
Treatment arm consisting of Tetrahydrocannabinol (5mg/capsule) and Cannabidiol (100mg/capsule).
干预措施: CBD/THC (Drug)
Placebo
Matched placebo capsule with no active ingredients.
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Digital Spirography
时间窗: Day 22 (100 minutes post-dose)
The tremor mean amplitude calculated using computerized spirography to measure kinetic tremors.
次要结局
- Number of Participants at Risk for Suicide Based on Columbia-Suicide Severity Rating Scale (C-SSRS)(Day 22)
- Number of Participants With New Study-related Electrocardiogram (EKG) Abnormalities(Day 22)
- Change in Score on a Scale From Baseline of the Tremor Research Group Essential Tremor Rating Scale (TETRAS)(Baseline and Day 22)
- Number of Participants Reporting Adverse Events Based on Common Terminology Criteria(Days 1, 3, 6, 22)
- Global Impression of Change(Day 22)
- Accelerometry-based Assessment of Tremor Severity(Baseline and Day 22)
研究者
Fatta B Nahab
Associate Professor of Neurosciences
University of California, San Diego