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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 主要终点
- Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject completed the preceding trial 243-05-001.
排除标准
- •Subject discontinued from the preceding trial 243-05-
- •Subject had a serious adverse event which association with the investigational drug was not ruled out during trial 243-05-
- •Subject has a persistent serious adverse event at the baseline, which was observed and association with the investigational drug was ruled out during trial 243-05-
- •Subject had persistent hallucination or delusion during trial 243-05-
- •Subject has psychiatric conditions such as confusion, excitation, delirium, abnormal behaviour at the baseline.
- •Subject has orthostatic hypotension at baseline.
- •Subject has a history of epilepsy, convulsion etc. during trial 243-05-
- •Subject has a complication of serious cardiac disorder.
- •Subject has arrhythmia and need to be treated with class 1a antiarrhythmic drugs (e.g. quinidine, procainamide etc.) or class 3 antiarrhythmic drugs (e.g. amiodarone, sotalol etc.).
- •Subject develops serious ECG abnormality at the baseline.
- •Subject has QTc-interval >= 500 msec at the baseline or subject has an increase of QTc-interval >= 60 msec from the baseline in the trial 243-05-001 and has a QTc-interval > 470 msec in female or > 450 msec in male at the baseline.
- •Subject had hypokalaemia in 243-05-001 study and not yet recovered.
- •Subject has a total bilirubin >= 3.0 mg/dL or AST(GOT) or ALT(GPT) greater than 2.5 times of the upper limit of the reference range (or >= 100 IU/L) at the end of the period in trial 243-05-
- •Subject has BUN >= 25 mg/dL or serum creatinine >= 2.0 mg/dl at the end of the taper period in trial 243-05-
- •Subject has a history of allergic reaction to topical agents such as transdermal patch. Subject showed serious or extensive application site reactions beyond the application site in the 243-05-001 study.
- •Subject who plans pregnancy during the trial.
- •Subject has dementia.
- •Subject is unable to give consent.
- •Subject is judged to be inappropriate for this trial by the investigator for the reasons other than above.
研究组 & 干预措施
SPM 962
干预措施: SPM 962 (Drug)
结局指标
主要结局
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters.
时间窗: 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
时间窗: 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
次要结局
- UPDRS Part 2 Sum Score(Baseline, Up to 54 weeks after dosing)
- Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score(Baseline, Up to 54 weeks after dosing)
- Absolute Time Spent "Off"(Up to 54 weeks after dosing)