Parkinson's Disease
Conditions
Interventions
This study wil recruit 130 individuals with Parkinson's Disease and Parkinson's Disease-related pain. They will be randomized into two groups: 65 subjects in group A (experimental) and the other 65 in
Sponsors
Hospital da Clínicas da Faculdade de Medicina da Universidade de São Paulo
Hospital da Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
25 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find better pain control, verified using the Parkinson Disease Pain Classification System scale, from the identification of a variation in the mean score between the first and last evaluation. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find the proportion of research subjects who present a reduction in the mean intensity of pain in the last 24 hours, using item 5 of the Brief Pain Inventory questionnaire, based on the observation of a reduction = 30% between the first and last evaluation .;Identify the frequency of adverse events during the entire follow-up period. Each adverse event will be described in detail during study assessments.;Identify the frequency of serious adverse events during the entire follow-up period.;Identify the frequency of patients who are withdrawn from the study due to adverse reactions throughout the follow-up period.;Identify the frequency of patients who show signs of dependence on the use of medication, through the analysis of the Severity of Dependence Scale, based on the finding of a score = 4 at any time during follow-up.; Identify motor and gait improvement, through the Timed Up and Go test, based on the observation of the variation in the average time between the first and last evaluation.;Evaluate the improvement of non-motor symptoms of Parkinson's Disease, verified using the Non-motor symptoms assessment scale for Parkinson's Disease, based on the observation of a variation in the mean score between the first and last evaluation.;Evaluate the reduction in anxiety and depression symptoms, verified using the Hospital Anxiety and Depression Scale, based on the observation of a variation in the mean score between the first and last evaluation.;Evaluate the improvement in the quality of life of patients with Parkinson's Disease, verified through item 8 of the Parkinson's Disease Questionnaire, based on the observation of a variation in the average score between the first and last evaluation.;Evaluate the improvement of motor symptoms in Parkinson's Disease, verified using the Movement Disorders Society Unified Parkinson's Disease Rating Scale part 3, based on the observation of a variation in the average score between the first and last evaluation | — |
Countries
Brazil
Contacts
Public ContactMateus Deltreggia
Hospital da Clínicas da Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed