Effects of cannabis components (THC and CBD) on motor and non-motor symptoms of Parkinson's disease: a placebo-controlled clinical study

Phase 2

• Conditions: Parkinson Disease; C10.574

• Registration Number: RBR-10n7gx74
• Lead Sponsor: niversidade Federal da Integração Latino-Americana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-03-21
• Last Update Posted: 2 April 2024
• Study Completion: 2024-11-20

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.