Safety of SPM 962 in a once-daily repeated long-term treatment in Parkinson's disease patients who are not concomitantly treated with L-dopa will be investigated with a doses.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
143
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 up to 54 weeks 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
Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score
Mean change (LOCF) from baseline in Total of UPDRS Part 2 sum score and Part 3 sum up to 54 weeks after dosingUPDRS 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 2 assesses 13 items and 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
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Unnamed facility
Shikoku Region, Japan
Unnamed facility
Tohoku Region, Japan