The primary objective of this study is to investigate safety of SPM 962 in advanced PD patients in a multi-center, open-label, non-controlled study following once-daily multiple transdermal doses of SPM962 within a range of 4.5 to 36.0 mg (maximum treatment period: 54 weeks). Efficacy is also to be exploratory investigated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
130
SPM 962 transdermal patch once a daily up to 36.0 mg/day
Unnamed facility
Chubu Region, Japan
Unnamed facility
Hokkaido Region, Japan
Unnamed facility
Kanto Region, Japan
Unnamed facility
Kinki Region, Japan
Unnamed facility
Kyushu Region, Japan
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters.
Incidence and severity of adverse events, vital signs, and laboratory parameters after dosing. \*decrease in difference between supine and standing systolic blood pressure
Time frame: Up to 55 weeks after dosing
Skin Irritation Score of the Application Site
Skin irritation score of the application site were evaluated according to the criteria below. The worst score throughout the treatment period was used in the analysis. -: no reaction, ±: mild erythema, +: erythema, ++: erythema and Oedema, +++: erythema and oedema and rash papular, or serous papule, or vesicles, ++++: bullosum
Time frame: Up to 55 weeks after dosing
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score
Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) up to 54 weeks after dosing UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.
Time frame: Baseline, Up to 54 weeks after dosing
UPDRS Part 2 Sum Score
Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) up to 54 weeks after dosing UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.
Time frame: Baseline, Up to 54 weeks after dosing
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Unnamed facility
Shikoku Region, Japan
Unnamed facility
Tohoku Region, Japan
Absolute Time Spent "Off"
Mean number of hours in "off state" during a 24-hour period.
Time frame: Up to 54 weeks after dosing