Parkinson Disease
Conditions
Interventions
This is a double-blind, randomized, placebo-controlled clinical trial, using placebo and a solution containing the combination of the cannabinoids CBD and THC as therapeutic tools, which will be admin
Treatment II)Placebo: Maintaining the same organoleptic and visual characteristics as treatments I and II (n=30). Treatment time of six months followed by a three-month open-label extension period, in
Sponsors
Universidade Federal da Integração Latino-Americana
Universidade Federal de Santa Catarina
Eligibility
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: Previous diagnosis of idiopathic Parkinson disease; Parkinson disease stage 3 or lower according to the Hoen and Yahr scale; age over 50 years; male or female; clinical manifestation of Parkinson Disease; stable treatment for at least 30 days; sign the informed consent form ICF
Exclusion criteria
Exclusion criteria: Medical decision that participation in the study is not best for the patient; presence of any condition that does not allow the protocol to proceed safely; clinically significant renal, hepatic and cardiovascular disorders previously identified or verified in the selection exams; use cannabinoids through any route of administration; diagnosis of alcohol dependence; history or have first-degree relatives with a history of any level of psychosis; have participated in clinical research projects in the two months prior to the start of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a significant improvement (p<0.05) in motor symptoms assessed by part III of the Unified Parkinson's Disease Rating Scale (UPDRS) in the group treated with an oral solution containing a combination of CBD/THC cannabinoids (50/5mg/ day). | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected that there will be a significant improvement (p<0.05) in the non-motor symptoms of PD for the following aspects: Pain intensity assessed by the visual analogue scale and McGill pain questionnaire; Quality of life assessed by the Parkinson's Disease Questionnaire-39 (PDQ-39); Motor performance in the trunk and upper extremity motor strength dimension assessed by dynamometry; Motor dimension of speed and displacement assessed by the Timed Up and Go Test and shuttle run test; Flexibility assessed by wells bank and biochemical parameters. | — |
Countries
Brazil
Contacts
Public ContactAna Ruver Martins
Universidade Federal de Santa Catarina
Outcome results
None listed