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| Outcome measures | Description |
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| Primary efficacy endpoint |
| Parkinson’s disease Sleep Scale 2nd version (PDSS-2) | The 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). There are three sub-scales from the three-factor solution, one comprising nocturnal movement-related problems (factor 1: “motor problems at night”), a second describing the disease specific symptoms (factor 2: “PD symptoms at night”) and the third representing sleep specific disturbances (factor 3: “Disturbed sleep”). A total score of ≥18 defines clinically relevant PD-specific sleep disturbances. According to previous study, any improvements in PDSS-2 less than −3.44 points could represent clinically important changes for the patients. That was to say, a minimal clinically important difference (MCID) of PDSS-2 [horvath et al. 2015] was -3.44 points. |
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| Secondary efficacy endpoints |
| Nocturnal Hypokinesia Questionnaire (NHQ) | The Nocturnal Hypokinesia Questionnaire is designed to assess hypokinesia symptoms in night in PD patients, composed of two sections. Section 1 is assessed by PD patients. There are four domains in section 1 to assess “turning over in bed,” “getting out of bed,” “Parkinsonian motor symptoms,” and “others” separately. The domains in Section 2 are the same with it in Section 1. Section 2 is assessed by spouses or caregivers who are with the patients during the night. |
| Scales for Outcomes in Parkinson’s Disease (SCOPA)-Sleep | The SCOPA-Sleep is a short, self-rating scale designed to evaluate nocturnal sleep quality and day-time sleepiness in patients with PD. It is composed of three parts: a night-time scale (NS), a single item about perceived quality of nocturnal sleep, and a day-time sleepiness scale (DS) that includes an item about unexpected onset of sleep. |
| | The NS is a five-item scale with four response options (0-not at all to 3-very much) that addresses nighttime disturbances that “occurred in the previous month.” The five items include sleep initiation, sleep fragmentation, sleep efficiency, sleep duration, and early wakening. Total NS score runs from 0 to 15, with higher scores reflecting more severe problems. The additional “quality of sleep” question assesses the overall night-time sleep quality on a seven-point scale (ranging from slept very well to slept very badly). This item is not included in the total NS score. The DS subscale evaluates day-time sleepiness, also in the past month, and includes six items with four response options, from 0 (never) to 3 (often), and a maximum total score of 18. These DS items were addressed as to how often the patient had fallen asleep unexpectedly, but in particular situations (while sitting quietly, watching TV or reading, and talking to someone) had had difficulty to remain awake and self-perception of day-time sleepiness as a problem. |
| Early Morning Off (EMO) | 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”). EMO score had to be rated before the first anti-PD drug taking in early morning, and within half an hour after waking up. The responder of EMO was the patient improved at least 1 comparing to his/her baseline condition. |
| Epworth Sleepiness Scale (ESS) | The ESS is a patient-rated scale about how likely one is to fall asleep during situations as passive and inconsequential as “watching TV” to as active as “sitting and talking to someone” and as consequential as “in a car, while stopped for a few minutes in traffic.” “Chance of dozing” is rated as an integer from 0 (no chance) to 3 (high). |
| Parkinson’s disease Questionnaire (PDQ) -8 | The PDQ-39 is a self-administered, disease specific measure of health status which covers eight dimensions of ill health and contains 39 questions. The 8 domains include mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. |
| | The PDQ-8 is an 8-item self-report questionnaire derived from PDQ-39. Each item selected is the one most highly correlated with the overall domain score to which it contributes. The items are summed together and transformed onto a score from 0 to 100. The PDQ-8 has been shown to exhibit appropriate levels of reliability, validity, and responsiveness. |
| Clinical Global Impression of Improvement (CGI-I) | The CGI was developed by the Early Clinical Drug Evaluation Unit (ECDEU) of the National Institute of Mental Health as an independent, simple way for clinicians to make overall evaluations of a patient’s central nervous system (CNS) disease status. The ratings were used initially in outpatients with various psychiatric disorders. 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, after interviewing the patient about the various aspects of the PD and after evaluating AE and concomitant treatments. The evaluator completed the scale by comparing the patients’ status during the past week to their baseline condition. |
| | The responder of CGI-I was the clinician rated of any improvement (1 = very much better, 2 = much better, or 3 = a little better). |
| Patient Global Impression of Improvement (PGI-I) | The PGI-I scale is a patient-rated instrument which was used to measure the improvement (from 1: Very much better, to 7: Very much worse) of the patient’s Parkinson disease symptoms throughout the study. Patients completed the scale by comparing their status during the past week to their baseline condition. The responder of PGI-I was the patient rated of any improvement (1 = very much better, 2 = much better, or 3 = a little better). |
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