Parkinson Disease
Conditions
Interventions
It will be administered in patients with Parkinson's disease and REM sleep behavior disorder the drug called canabidiol(CBD) in progressive doses of 75 until 300mg for 12 weeks in 20 patients (group 1
Drug
C10.886.659.633.700
C10.886.659.633
Sponsors
Universidade de Sao Paulo
Universidade de Sao Paulo
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis of PD according to criteria of the London Brain Bank in stage 1-3 of the Hoehn and Yahr scale;Over 18 years of age;Diagnosis of RBD according to the criteria of the 3rd edition of the International Classification of Sleep Disorders (CIDS-3);With sufficient severity and frequency to indicate a symptomatic treatment, ie with a frequency of 2 or more episodes per week;That they agree to participate in the study.
Exclusion criteria
Exclusion criteria: In adjustment of antiparkinsonian medications; With diagnosis of dementia; Presenting significant hallucinations (score> 2 in the MDS-UPDRS psychosis item); Introducing delusions; With depression; Without a partner with whom you share your bedroom;With severe or decompensated systemic diseases;With probable mild TCSREM, with sporadic episodes and not clinically significant;Alcoholism or use of illicit drugs;Patients in stage 4-5 of the Hoehn and Yahr scale.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-A reduction of at least 50% in the frequency of motor symptoms measured by the sleep diary after 12 weeks of intervention. ;A sleep diary will be used to report on the frequency of nocturnal movements. This questionnaire will be completed by the patient or caregivers daily during the baseline period and during the intervention phase that will have 12 consecutive weeks. A reduction of at least 50 percent of the violent nighttime movements is expected in comparison to the baseline period in those who used Canabidiol compared to the placebo group. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-Improvement of the general quality of sleep through Pittsburgh sleep questionnaire; 2-Improvement of the Parkinson's Sleep Scale (PDSS).;The Pittsburgh Sleep Quality Scale will be used to report on subjective sleep quality of patients. The Pittsburgh questionnaire is used worldwide in sleep quality research, it consists of 19 items grouped into 7 major groups that assess duration, latency, sleep efficiency, and daytime complaints. Each group receives a score of 0-3 that is summed to compose a final score or PSQI-Pittsburgh Scale Questionnaire Index, which ranges from 0-21 points. Higher scores indicate poor sleep quality. The choice of such questionnaire was made because it is widely used and easy to apply. With a 5-point cutoff level, it reaches a sensitivity of 89.6% and specificity of 86.5% differentiating healthy individuals from patients with sleep complaints ("good sleeper / bad sleeper"). It will be applied at baseline and after 12 weeks of intervention. An improvement in sleep quality is expected in the cannabidiol group. Patients will also be evaluated through a sleep scale specially developed for PD and called PDSS (Parkinson's Disease Sleep Scale). It is a self-applicable scale consisting of fifteen items, each scoring from zero to four points. The total score ranges from zero (no sleep disturbance) to 60 points. It will be applied at baseline and after 12 weeks of intervention. An improvement in sleep quality in the PDSS group is expected in the cannabidiol group. | — |
Countries
Brazil
Contacts
Public ContactCarlos Almeida
Universidade de Sao Paulo
Outcome results
None listed