An Open-label Long-term Extension Trial From Phase II/III of SPM962 (243-07-001) in Early Parkinson's Disease Patients With Non-concomitant Treatment of L-dopa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 143
- 主要终点
- Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters
研究概览
简要总结
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.
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 243-07-001 (NCT00537485)
排除标准
- •Subject discontinued from the preceding trial 243-07-
- •Subject had a serious adverse event which association with the investigational drug was not ruled out during trial 243-07-
- •Subject has a persistent serious adverse event at the baseline, which was observed and association with the investigational drug was ruled out during trial 243-07-
- •Subject had persistent hallucination or delusion during trial 243-07-
- •Subject has psychiatric conditions such as confusion, excitation, delirium, abnormal behaviour at the baseline.
- •Subject has orthostatic hypotension or a systolic blood pressure (SBP) <= 100 mmHg and has a decrease of SBP from spine to standing position >= 30 mmHg at baseline.
- •Subject has a history of epilepsy, convulsion etc. during trial 243-07-
- •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 243-07-001 and has a QTc-interval > 470 msec in female or > 450 msec in male at the baseline.
- •Subject has a serum potassium level < 3.5 mEq/L at the end of the taper period in trial 243-07-
- •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 243-07-
- •Subject has BUN >= 30 mg/dL or serum creatinine >= 2.0 mg/dl at the end of the taper period in trial 243-07-
- •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
SPM 962 transdermal patch
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 up to 54 weeks 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
- Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score(Baseline, Up to 54 weeks after dosing)