A Long-Term Extension Trial From Late Phase II of SPM 962 in Advanced Parkinson's Disease Patients
|ClinicalTrials.gov Identifier: NCT01631812|
Recruitment Status : Completed
First Posted : June 29, 2012
Results First Posted : March 19, 2014
Last Update Posted : March 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Drug: SPM 962||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Long-term Extension Trial From Late Phase II of SPM962 (243-05-001) in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
|Experimental: SPM 962||
Drug: SPM 962
SPM 962 transdermal patch once a daily up to 36.0 mg/day
- Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters. [ Time Frame: Up to 55 weeks after dosing ]
Incidence and severity of adverse events, vital signs, and laboratory parameters after dosing.
*decrease in difference between supine and standing systolic blood pressure
- Skin Irritation Score of the Application Site [ Time Frame: Up to 55 weeks after dosing ]
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
- Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score [ Time Frame: Baseline, Up to 54 weeks after dosing ]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.
- UPDRS Part 2 Sum Score [ Time Frame: Baseline, Up to 54 weeks after dosing ]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.
- Absolute Time Spent "Off" [ Time Frame: Up to 54 weeks after dosing ]Mean number of hours in "off state" during a 24-hour period.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631812
|Chubu Region, Japan|
|Hokkaido Region, Japan|
|Kanto Region, Japan|
|Kinki Region, Japan|
|Kyushu Region, Japan|
|Shikoku Region, Japan|
|Tohoku Region, Japan|
|Study Director:||Kyoji Imaoka, Mr||Otsuka Pharmaceutical Co., Ltd.|