Open-Label Study of Sleep Disturbances in Patients with Parkinson's Disease Treated with Rasagiline.
BACKGROUND
The prevalence of sleep disturbances among patients with Parkinson's disease (PD) is estimated to occur in 37% to 98% of patients. Sleep disturbances have been associated with a reduced quality of life for patients with PD. The objective of this study was to assess the impact of rasagiline treatment on the severity of sleep disturbances among patients with idiopathic PD.


METHODS
In this open-label, multicentre study, 110 adult patients with idiopathic PD were treated with rasagiline either as monotherapy or as adjunct therapy. The primary endpoint was the change in severity of sleep disturbances, assessed with the PD Sleep Scale from baseline to month 2. Exploratory endpoints included change in daytime sleepiness, assessed with the Epworth Sleep Scale, treatment satisfaction measured with the Treatment Satisfaction Questionnaire for Medication, patient's overall improvement or deterioration over time measured with the Clinical Global Impression of Improvement, tolerability, and safety.


RESULTS
Patients treated with rasagiline as mono- or adjunct therapy showed a statistically significant improvement in sleep quality after 2 months. There was no change in daytime sleepiness. Overall, patients were satisfied with rasagiline treatment with a mean Treatment Satisfaction Questionnaire for Medication [standard deviation] total score at month 2 of 68% [16.1]. At the end of study, 64 patients (65.9%) were judged, by the investigator, as being at least minimally improved from baseline on the Clinical Global Impression of Improvement. Rasagiline was safe and well-tolerated.


CONCLUSIONS
Rasagiline as mono- or adjunct-therapy may improve sleep experience in patients with PD in the short term.
1Centre Hospitalier de l'Université de Montréal (University of Montreal Hospital Center) and Centre de recherche du Centre Hospitalier de l'Université de Montréal (University of Montreal Hospital Center Research Center) Hôpital Notre-Dame,Département de médecine (Neurologie) Université de Montréal,Montréal,Québec.
Michel
M
Panisset
2former employees of TEVA Canada Innovation,Montréal,Québec.
Jean-Louis
JL
Stril
2former employees of TEVA Canada Innovation,Montréal,Québec.
Manon
M
Bélanger
2former employees of TEVA Canada Innovation,Montréal,Québec.
Geneviève
G
Lehoux
3Boolean Research Consulting Services,Montreal,Québec.
Donna
D
Coffin
1Centre Hospitalier de l'Université de Montréal (University of Montreal Hospital Center) and Centre de recherche du Centre Hospitalier de l'Université de Montréal (University of Montreal Hospital Center Research Center) Hôpital Notre-Dame,Département de médecine (Neurologie) Université de Montréal,Montréal,Québec.
Sylvain
S
Chouinard
D000368:Aged; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007189:Indans / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000627:therapeutic use*; D010300:Parkinson Disease / Q000150:complications*; D011569:Psychiatric Status Rating Scales; D012189:Retrospective Studies; D012720:Severity of Illness Index; D012893:Sleep Wake Disorders / Q000188:drug therapy* / Q000209:etiology*; D016896:Treatment Outcome
D007189:Indans; D018696:Neuroprotective Agents; C031967:rasagiline
Parkinson disease; Rasagiline; Sleep