NCT01631825已完成3 期
An Open-label Long-term Extension Trial From Phase III of SPM962 (243-08-002) in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 321
- 主要终点
- Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
研究概览
简要总结
- To investigate the safety of once-daily repeated transdermal administration of SPM 962 within a dose range of 4.5 to 36.0 mg/day (54-week treatment period) in Parkinson's disease (PD) patients treated concomitantly with L-dopa in a multi-center, open-label uncontrolled study.
- To investigate efficacy of SPM 962 in an exploratory manner.
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 243-08-001.
排除标准
- •Subject discontinued from the preceding trial 243-08-
- •Subject had a serious adverse event which association with the investigational drug was not ruled out during trial 243-08-
- •Subject has a persistent serious adverse event at the baseline, which was observed and association with the investigational drug was ruled out during trial 243-08-
- •Subject had persistent confusion, hallucination, delusion or excitation during trial 243-08-
- •Subject has abnormal behavior such as obsessive-compulsive disorder and delusion in 243-08-001 study.
- •Subject showed serious or extensive application site reactions beyond the application site in the 243-08-001 study.
- •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 243-08-
- •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 243-08-001 and has a QTc-interval > 470 msec in female or > 450 msec in male at the baseline.
- •Subject had a serum potassium level < 3.5 mEq/L at the end of the taper period in trial 243-08-
- •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 243-08-
- •Subject had BUN >= 30 mg/dL or serum creatinine >= 2.0 mg/dl at the end of the taper period in trial 243-08-
- •Subject who plans pregnancy during the trial.
- •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
Experimental
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 (AEs), Vital Signs, and Laboratory Parameters
时间窗: Up to 55 weeks after dosing
The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of AEs, vital signs, and laboratory parameters. AEs of special interest (1-3) are defined as below: 1. sudden onset of sleep 2. obsessive-compulsive disorder or impulse-control disorder 3. hallucination, delusion Application site reaction is scored as -, ±, +, ++, +++, or ++++. More + indicates a greater severity of symptoms. The worst score obtained throughout the evaluation period was to be assessed.
次要结局
- Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score(Baseline, Up to 54 weeks after dosing)
- UPDRS Part 2 Sum Score (Average of on State and Off State)(Baseline, up to 54 weeks after dosing)
- Absolute Time Spent "Off"(Baseline, up to 54 weeks after dosing)
- UPDRS Part 1 Sum Score(Baseline, up to 54 weeks after dosing)
- UPDRS Part 2 Sum Score (On State)(Baseline, up to 54 weeks after dosing)
- UPDRS Part 2 Sum Score (Off State)(Baseline, up to 54 weeks after dosing)
- UPDRS Part 4 Sum Score(Baseline, up to 54 weeks after dosing)
- Total of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average of on State and Off State), UPDRS Part 3 Sum Score (on State), and UPDRS Part 4 Sum Score(Baseline, up to 54 weeks after dosing)
- The Modified Hoehn & Yahr Severity of Illness(Baseline, up to 54 weeks after dosing.)
- Each Item of UPDRS Part 1(Baseline, up to 54 weeks after dosing.)
- Each Item of UPDRS Part 2 (on State)(Baseline, up to 54 weeks after dosing.)
- Each Item of UPDRS Part 2 (Off State)(Baseline, up to 54 weeks after dosing.)
- Each Item of UPDRS Part 2 (Average of on State and Off State)(Baseline, up to 54 weeks after dosing.)
- Total of UPDRS Part 2 Sum Score (Average of on State and Off State) and UPDRS Part 3 Sum Score (on State)(Baseline, up to 54 weeks after dosing)
- Each Item of UPDRS Part 3 (on State)(Baseline, up to 54 weeks after dosing.)
- Each Item of UPDRS Part 4(Baseline, up to 54 weeks after dosing.)
研究者
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