Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial to Evaluate Safety and Tolerability of Cannabidiol (Kanbis®) for the Treatment of Parkinson&#39;s Disease Symptoms

Laboratorio Elea Phoenix S.A.1 个研究点分布在 1 个国家目标入组 88 人开始时间: 2024年11月28日最近更新: 2024年12月5日

适应症

干预措施

试验速览

阶段: 2 期
状态: 招募中
发起方: Laboratorio Elea Phoenix S.A.
入组人数: 88
试验地点: 1
主要终点: Number of patients with advers events related to treatment acording to CTCAE v5.0

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Parkinson disease (PD) is a chronic, progressive neurodegenerative disorder characterized by clinical motor and non-motor symptoms. Knowing the potential benefits has led to the use of cannabis as an alternative therapy.

详细描述

To evaluate safety and tolerability of CBD-based drug product at different doses

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 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Participants between 40 and 80 years old.
•Participants diagnosed with PD according to Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease (72), and to the Brain Bank Criteria for Parkinson's disease, with mild to moderate disease as measured by the modified Hoehn and Yahr scale. (Both clinical criteria are included since many of the study participants were diagnosed with previous criteria and others with current criteria, both of which are very similar and do not change or raise any doubt about the diagnosis of the disease).
•Participants who have not changed their anti-Parkinson's drugs (or dose) at least one month prior to study entry.
•Acceptance by the participant by signing the ICF.
•Subjects capable of giving consent to participate in the study

排除标准

•Evidence of dementia, Mini-Mental State Exam score less than 24 or with previous diagnosis by cognitive assessment .
•Severe psychiatric pathology: severe depression, treatment-refractory psychosis. Evaluation by psychiatrist who confirms the pathology. History of hospitalization in a psychiatric center or mental health center is an exclusion criterion regardless of the time spent since hospitalization or the reason for which the patient was hospitalized.
•Known or suspected allergy to cannabinoids or inactive ingredients used in the formulation of the study drug.
•History of drug or alcohol dependence.
•Use of dopamine blockers within 180 days prior to study entry.
•Use of amphetamine inhibitors, cocaine and MAO-A inhibitors within 90 days prior to study entry.
•Patients who have received within 90 days prior to study entry the following drugs due to drug interactions: valproic acid, felbamate, niacin (nicotinic acid) at doses ≥2000mg/day or nicotinamide (nicotinic acid amide or nicotinamide) at doses ≥3000mg/day, isoniazid, ketoconazole and/or clobazam.
•Unstable medical condition detected by the following laboratory alterations: Hemoglobin<10g/dL, Leukocytes<4000 u/ml, Neutrophils<1500 u/ml, Lymphocytes<500u/ml, Platelets<100000 u/ml, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)> 3 times the upper limit of normal.
•Moderate-severe liver disease. (Child Pugh B-C)
•Pregnant or breastfeeding.
•Women of reproductive age who do not agree to use at least one contraceptive method of proven efficacy (diaphragm or partner using condom, oral or implanted hormonal contraceptive; intrauterine device, stable partner with vasectomy), until at least four weeks after completion of study treatment. Pregnancy blood test will be performed before starting the study.
•Participants who have had a surgical procedure for PD, either deep brain stimulation or surgery for lesion.
•Patients de novo or with recent diagnosis of PD (less than 5 years).