An Open-label Long-term Extension Trial From Late Phase II of SPM 962 (243-07-003) in Patients With Restless Legs Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 185
- 主要终点
- The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
研究概览
简要总结
The aims of the trial are to assess the safety and the efficacy of SPM 962 following once-a-daily transdermal administration within a range of 2.25 to 6.75 mg/day in Japanese patients with restless legs syndrome (RLS) in a multi-center, open-label trial. The maximum treatment period is 53 weeks. The trial is an extension trial from the precedent 6-week, double-blind, randomized, placebo-controlled, parallel-group comparative trial(243-07-003). The trial is also for an exploratory investigation of incidence of augmentation, the most problematic complications in dopaminergic treatment.
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
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject completed the preceding trial 243-07-003 (NCT00666965)
排除标准
- •Subject discontinued from the preceding trial 243-07-003 (NCT00666965)
- •Subject had a serious adverse event which association with the investigational drug is not ruled out during trial 243-07-003
- •Subject had a persistent serious adverse event at the baseline, which was observed and association with the investigational drug is ruled out during trial 243-07-
- •Subject had persistent hallucination or delusion during trial 243-07-
- •Subject had psychiatric conditions such as confusion, excitation, delirium, abnormal behaviour at the baseline.
- •Subject had orthostatic hypotension or a systolic blood pressure (SBP) ≤ 100 mmHg and had a decrease of SBP from spine to standing position ≥ 30 mmHg at baseline.
- •Subject had a history of epilepsy, convulsion etc. during trial 243-07-
- •Subject developed serious ECG abnormality at the baseline.
- •Subject had QTc-interval ≥ 500 msec at the baseline or subject had an increase of QTc-interval ≥ 60 msec from the baseline in the trial 243-07-003 and had 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 243-07-
- •Subject had 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 had BUN ≥ 30 mg/dL or serum creatinine ≥ 2.0 mg/dl at the end of the taper period in trial 243-07-
- •Subject who planned pregnancy during the trial.
- •Subject was 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
Rotigotine transdermal patch
干预措施: SPM 962 (Drug)
结局指标
主要结局
The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
时间窗: Up to 54 weeks
The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of adverse events, 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
Augmentation
时间窗: Up to 53 weeks
Augmentation is the main complication during long-term dopaminergic treatment of restless legs syndrome (RLS) and reflects an overall increase in RLS severity. Augmentation is clinically significant when at least one of the following occurs: 1. Change in daily activities and/or behavior (e.g., the patient stops riding in cars in the afternoon) due to augmentation; 2. Negative impact on the patient's quality of life (sleep, mood, etc.) due to augmentation; 3. Need to change the treatment dose or the patienｔ needs to take the dose earlier in the day (e.g., dividing the dose); 4. Adjustments in concomitant medication are made to compensate for augmented RLS symptoms (e.g., an increased intake of analgesics or hypnotics to cover an increase in symptom intensity); 5. Any other aspect as judged by the evaluator (should be specified).
Change of the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Each Visit
时间窗: Baseline, Up to 53 weeks
PSQI is a scale for assessing severity of sleep disorders. The score ranges from 0 to 21. 0 indicates "no difficulty" and 21 indicates "severe difficulty". A decrease in the scores means improvement.
次要结局
- Change of IRLS Sum Score From the Baseline to Each Visit(Baseline, Up to 53 weeks)
- Efficacy Rate in IRLS Sum Score(Baseline, Up to 53 weeks)
- Change of Augmentation Severity Rating Scale (ASRS) Sum Score From Baseline to Each Visit(Baseline, Up to 52 weeks)
- Change of Short-Form 36-Item Health Survey (SF-36) From Baseline to Each Visit(Baseline, Up to 53 weeks)