The efficacy and safety of rotigotine in the treatment of patients with early stage of primary Parkinson's disease
To evaluate the efficacy and safety of rotigotine sustained release microspheres therapy by injection in the treatment of patients with early stage of primary Parkinson's disease
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
294
LY03003 (Continuous Dopamine Stimulation) sustained release microspheres / injection once a week 4 weeks followed by 24 weeks until 28 weeks.
Null sustained release microspheres placebo / injection once a week 4 weeks followed by 24 weeks until 28 weeks.
Peking University Third Hospital
Beijing, China
Changes in the total Unified Parkinson Disease Rating Scale (UPDRS) (II +III) score
Changes in the total Unified Parkinson Disease Rating Scale (UPDRS) (II +III) score relative to baseline from baseline to the end of the double-blind dose maintenance period, The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Some sections of the UPDRS scale require multiple grades assigned to each extremity with a possible maximum of 199 points. A score of 199 on the UPDRS scale represents the worst (total disability) with a score of zero representing (no disability).
Time frame: 32 weeks after treatment
Unified Parkinson Disease Rating Scale (UPDRS) maximum table (II +III) total score
Unified Parkinson Disease Rating Scale (UPDRS) maximum table (II +III) total score relative to baseline from baseline to the end of the double-blind dose maintenance period, The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Some sections of the UPDRS scale require multiple grades assigned to each extremity with a possible maximum of 199 points. A score of 199 on the UPDRS scale represents the worst (total disability) with a score of zero representing (no disability).
Time frame: 32 weeks after treatment
changes in part II of the Unified Parkinson Disease Rating Scale relative to baseline
Changes from baseline to the end of the double-blind dose maintenance period in part III of the Unified Parkinson Disease Rating Scale relative to baseline; The Unified Parkinson Disease Rating Scale scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Some sections of the Unified Parkinson Disease Rating Scale scale require multiple grades assigned to each extremity with a possible maximum of 199 points. A score of 199 on the Unified Parkinson Disease Rating scale represents the worst (total disability) with a score of zero representing (no disability).
Time frame: 32 weeks after treatment
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changes in the severity (SI) score;
From baseline to the end of the double-blind dose maintenance period, changes in the severity (SI) score of Item 1 ;The Severity Score (ISS) scores ranges from 0 to 75 (i.e. Abbreviated Scale (AIS) scores of 6 for each injury in every body region according to its relative severity). If an injury is assigned an Abbreviated Injury Scale (AIS) of 6 (identified currently as untreatable injury or unsurvivable injury), the ISS score is automatically assigned 75. Since a score of 6 ("unsurvivable") indicates the futility of further medical care in preserving life, this may mean a cessation of further care in triage for a patient with a score of 6 in any category.
Time frame: 32 weeks after treatment
Changes in pd Questionnaire (PDQ-8) scores
Changes in pd Questionnaire (PDQ-8) scores relative to baseline from baseline to the end of the double-blind dose maintenance period; the higher the score, the worse of life quality
Time frame: 32 weeks after treatment
Changes in pd sleep Disorders Scale (PDSS) score
Changes in pd sleep Disorders Scale (PDSS) score from baseline to the end of the double-blind dose maintenance period. The overall PDSS is the summary score of the single PDSS items. If the single items have values between 0 (= worst case) to 10 (= best case) the total score can range between 0 and 150. Score 150 means the best case.
Time frame: 32 weeks after treatment
Changes in Beck Depression Inventory II (BDI-II) scores
Changes in Beck Depression Inventory II (BDI-II) scores relative to baseline from baseline to the end of the double-blind dose maintenance period. Each item of the BDI-II is rated along a 4-point Likert scale from 0 to 3; Items are summed to produce a total score(0-63) with higher scores representing more depressive symptoms.
Time frame: 32 weeks after treatment