Parkinson Disease
Conditions
Interventions
This is an open pharmacovigilance clinical study with a duration of 24 months, following a previous clinical trial. There will be a single, non-randomized experimental group consisting of 68 male or f
Sponsors
Universidade Federal de Santa Catarina
Universidade Federal de Santa Catarina
Eligibility
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: Having completed the double-blind phase of the study without interruptions; having not presented serious adverse effects in the double-blind phase; signing the informed consent form; age 50 or older; male or female
Exclusion criteria
Exclusion criteria: Medical decision that participation in the study is not in the best interest of the patient; presence of any condition that does not allow the protocol to be followed safely, such as serious adverse effects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The treatment with the cannabinoid solution is expected to demonstrate a significant long-term improvement (p<0.05) in the motor symptoms of Parkinson’s disease, as assessed by the Unified Parkinson’s Disease Rating Scale. Therefore, it may be recommended as a maintenance therapy for Parkinson's disease | — |
Secondary
| Measure | Time frame |
|---|---|
| The expected outcome is that, in the long term, the quality of life of patients with Parkinson’s disease will be maintained concerning non-motor symptoms in the following aspects: pain intensity, anxiety, depression, sleep quality, and laboratory parameters | — |
Countries
Brazil
Contacts
Public ContactAna Ruver Martins
Universidade Federal de Santa Catarina
Outcome results
None listed