The main objective of the study is to explore firstly, then further evaluate and confirm the efficacy between Pramipexole Sustained Release (SR) versus Pramipexole Immediate Release (IR) on nocturnal symptoms (as measured by the change from baseline to the end of the maintenance period in Parkinson's Disease Sleep Scale 2nd version (PDSS-2) score) in L-dopa+ treated patients with advanced Parkinson's disease (PD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
98
Tablets
Tablets
Peking Union Medical College Hospital
Beijing, China
Beijing Hospital
Beijing, China
West China Hospital
Chengdu, China
The First Afiliated Hospital, Sun Yet-sen University
Guangzhou, China
2nd Affiliated Hosp Zhejiang University College of Medical
Hangzhou, China
Brain Hospital Affiliated to Nanjing Med University
Nanjing, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
The First Hospital of Chinese Medical University
Shenyang, China
The Second Affiliated Hospital of Soochow University
Suzhou, China
Tianjin Medical University General Hospital
Tianjin, China
...and 2 more locations
Change From Baseline to Week 18 in Parkinson's Disease Sleep Scale 2nd Version (PDSS-2) Total Score
Parkinson's disease Sleep Scale 2nd version (PDSS-2) consists of 15 questions about various sleep and nocturnal disturbances which are to be rated by the patients using one of five categories, from 0 (never) to 4 (very often). Patients were asked to rate the severity of each question based on their experience during the past week (7 days) from 0 (Never) to 4 (Very often, that meant 6 to 7 days a week). PDSS-2 total score ranges from 0 (no disturbance) to 60 (maximum nocturnal disturbance).
Time frame: Baseline and Week 18
Nocturnal Hypokinesia Questionnaire (NHQ) Score (Change From Baseline)
The Nocturnal Hypokinesia Questionnaire (NHQ) is designed to assess hypokinesia symptoms in night in Parkinson's disease (PD) patients, composed of two sections. Section 1 is assessed by PD patients with 10 one-point items evaluating "turning over in bed", "getting out of bed", "parkinsonian motor symptoms", and "others". Section 2 is assessed by spouses or caregivers who are with the patients during the night with 10 one-point items evaluating the same aspects as Section 1. The score for each section is by summing up points from the items in the respective section. Score of each of the two Sections is from 0 to 10, with a higher score indicating worse symptoms. The score was reported by section: Section 1 by patients, Section 2 by caregivers.
Time frame: Baseline and Week 18
Scale for Outcomes in Parkinson's Disease (SCOPA)-Sleep Score (Change From Baseline)
SCOPA-Sleep score is composed of three parts: a night-time scale (5 item scale with 4 Response Options (0-not at all to 3-very much) addressing night time disturbances. Total night-time scale score runs from 0 to 15, with a higher score indicating more severe problems, a single-item about perceived quality of nocturnal sleep (7-point scale ranging from slept very well to slept very badly.), and a daytime sleepiness scale (6 items with 4 Response options, from 0 (never) to 3 (often), and a maximum total score of 18.).
Time frame: Baseline and Week 18
Early Morning Off (EMO) Score (Change From Baseline)
The EMO is measured by the question of "do you feel like your bodily movements are poor when you wake up?" Patients answered this question according to the frequency during the previous one week by scoring from 0 ("never") to 4 ("very often" or "6 to 7 days a week").
Time frame: Baseline and Week 18
Responder Rate for Parkinson's Disease Sleep Scale 2nd Version (PDSS-2) Total Score<18
Parkinson's disease Sleep Scale 2nd version (PDSS-2) consists of 15 questions about various sleep and nocturnal disturbances which are to be rated by the patients using one of five categories, from 0 (never) to 4 (very often) based on their experience during the past week. PDSS-2 total score ranges from 0 (no disturbance) to 60 (maximum nocturnal disturbance). The PDSS-2 total score less \< 18 were compared between groups.
Time frame: At Week 18
Responder Rate for Early Morning Off (EMO) Score
The responder of EMO is the patient with an improvement of at least 1 comparing to his/her baseline condition. The EMO is measured by the question of "do you feel like your bodily movements are poor when you wake up?" Patients answered this question according to the frequency during the previous one week by scoring from 0 ("never") to 4 ("very often" or "6 to 7 days a week").
Time frame: At Week 18
The Parkinson's Disease Questionnaire (PDQ)-8 Score (Change From Baseline)
The PDQ-8 is a self-reported questionnaire consisting of 8 questions regarding the subject's disease symptoms. The total score summed up the items together and transformed onto a score from 0 (never have problems/issues) to 100 (always have problems or cannot do at all).
Time frame: Baseline and Week 18
Responder Rate for Clinical Global Impression of Improvement (CGI-I)
The responder of CGI-I is the patient rated of any improvement (1 = Very much better, 2 = Much better, or 3 = A little better). The CGI-I was rated (from 1: very much improved, to 7: very much worse) by the same evaluator to assess the overall status of Parkinson's disease.
Time frame: At Week 18
Responder Rate for Patient Global Impression of Improvement (PGI-I)
The responder of PGI-I is the patient rated of any improvement (1 = Very much better, 2 = Much better, or 3 = A little better). The PGI-I scale is a patient-rated instrument (from 1: very much better, to 7: very much worse) which was used to measure the improvement of the patient's Parkinson disease symptoms throughout the study.
Time frame: At Week 18
Epworth Sleepiness Scale (ESS) Score (Change From Baseline)
The ESS is a patient-rated scale about how likely one is to fall asleep during situations of passive and inconsequential to active. The total score ranges from 0-24 where higher values indicate greater daytime sleepiness.
Time frame: Baseline and Week 18
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