Treatment of non-motor symptoms of Parkinson's disease with purified extract of Cannabis sativa

Hospital da Clínicas da Faculdade de Medicina da Universidade de São Paulo0 个研究点开始时间: 2023年1月25日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Over 25 years of age; Diagnosis of Parkinson's Disease according to Movement Disorder Society criteria; Present pain related to Parkinson's disease according to the criteria of the Parkinson Disease Pain Classification System Questionnaire; Suffer from chronic pain according to the definition of chronic pain recommended by the 11th edition of the International Classification of Diseases; Able to provide informed consent; Have easy access to a telephone

•Allergy any component of the studied test solutions;Patients using medications with a narrow therapeutic index, and clinically relevant risk due to significant pharmacological interactions with medication studied; Clinically relevant current liver disease, at the discretion of the investigators, and/or hepatitis C; Concomitant use of valproic acid and/or its derivatives;
•Personal history of schizophrenia and/or bipolar affective disorder; History of psychotic symptoms not justified by Parkinson's Disease; History of suicidal ideation, planning and/or attempt; Research subjects who will not be able to attend to the trial's follow-up assessments; Subjects who do not understand Portuguese; Women of childbearing age, unless they are using an Intrauterine Device or had been previously submitted to tubal ligation; Severe non-compensated psychiatric comorbidities, at the discretion of the researchers; Severe non-compensated clinical comorbidities, at the discretion of the researchers; Pregnant or breastfeeding women; Use in the past 2 years of Cannabis sp. and/or its derivatives for recreational or therapeutic purposes; Personal history of cannabis use disorder and/or other illicit drugs; Personal history of alcohol, tobacco, opioid, benzodiazepine, barbiturate and/or other substance use disorder

发起方

Hospital da Clínicas da Faculdade de Medicina da Universidade de São Paulo