* To demonstrate the non-inferiority of SPM 962 to ropinirole in terms of efficacy in order to confirm clinical value of SPM 962. * To demonstrate the superiority of SPM 962 to placebo in terms of efficacy. * To investigate the tolerability and safety of SPM 962 up to 36.0 mg/day.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
420
SPM 962 transdermal patch once a daily up to 36.0 mg/day
Ropinirole oral administration TID up to 15.0 mg/day
SPM962-placebo patch and Ropinirole-placebo tab
Unnamed facility
Chubu Region, Japan
Unnamed facility
Chugoku Region, Japan
Unnamed facility
Hokkaido Region, Japan
Unnamed facility
Kanto Region, Japan
Unnamed facility
Unified Parkinson's Disease Rating Score (UPDRS) Part 3 Sum Score
Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 16 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, 16 weeks after dosing
UPDRS Part 3 Sum Score
Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 8 and 10 weeks after dosing. UPDRS 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, 8 and 10 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) at 16 weeks after dosing. UPDRS 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, 16 weeks after dosing
Off Time
Mean change (LOCF) from baseline in off time at 16 weeks after dosing. Off-time is a state where L-Dopa becomes ineffective. Off-time was measured by patient diary in hours/day.
Time frame: Baseline, 16 weeks after dosing
Parkinson's Disease Sleep Scale-2 (PDSS-2)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Kinki Region, Japan
Unnamed facility
Kyushu Region, Japan
Unnamed facility
Shikoku Region, Japan
Unnamed facility
Tohoku Region, Japan
Mean change (LOCF) from baseline in PDSS-2 sum score at 16 weeks after dosing. PDSS-2 is a scale for assessing sleep disorders in Parkinson's disease. PDSS consists of 15 questions about sleep and nocturnal disturbances. The score of each question ranges from 0 (never) to 4 (very frequent). The sum of each question serves as the scale score. Thus a decrease in the scores means improvement.
Time frame: Baseline, 16 weeks after dosing
On Time
Mean change (LOCF) from baseline in on time at 16 weeks after dosing. On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day.
Time frame: Baseline, 16 weeks after dosing
On Time Without Dyskinesia Disturbing Daily Activities
Mean change (LOCF) from baseline in on time without dyskinesia disturbing daily activities at 16 weeks after dosing. On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day.
Time frame: Baseline, 16 weeks after dosing
On Time With Dyskinesia Disturbing Daily Activities
Mean change (LOCF) from baseline in on time with dyskinesia disturbing daily activities at 16 weeks after dosing (rate against on time).
Time frame: Baseline, 16 weeks after dosing
Effective Rate in UPDRS Part 3 Sum Score
Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 3 sum score (on state) at 16 weeks after dosing.
Time frame: Baseline, 16 weeks after dosing
Effective Rate in UPDRS Part 2 Sum Score
Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score (average scores of on state and off state) at 16 weeks after dosing.
Time frame: Baseline, 16 weeks after dosing
Effective Rate in Off Time
Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in off time at 16 weeks after dosing. On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day.
Time frame: Baseline, 16 weeks after dosing
Clinical Global Impression (CGI)
Change (LOCF) from baseline in CGI score. CGI improvement is a clinician-reported scale for assessing how much the patient's illness has improved or worsened from baseline. The scale scoring criteria are 1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse, 7: very much worse. A decrease in the scores means improvement.
Time frame: Baseline, 16 weeks after dosing
Dystonia (at an Early Hour)
Change (LOCF) from baseline in occurrence of Dystonia (at an early hour).
Time frame: Baseline, 16 weeks after dosing
Dystonia (in the Daytime)
Change (LOCF) from baseline in occurrence of Dystonia (in the daytime).
Time frame: Baseline, 16 weeks after dosing