NCT00498186已完成2 期
An Open-label Extension Trial to Determine Safety and Tolerability of Long-term Transdermal Application of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 295
- 主要终点
- Number of Subjects With at Least One Adverse Event, as Reported Spontaneously by the Subject or Observed by the Investigator, During the 5-year Open-label Extension.
研究概览
简要总结
This is a multi-center, open-label extension trial conducted at the same European sites that participated in trial SP 709 (NCT00243217). The trial is designed to collect long-term safety and tolerability, efficacy correlates, and quality of life data in subjects with idiopathic Restless Leg Syndrome (RLS). The duration of treatment is approximately 5 years. Subject will be up-titrated to their optimal dose (administration of 1 patch per day, 5 different doses and patch sizes).
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has completed the preceding trial SP709 (NCT00243217)
排除标准
- •Subject did suffer from a serious adverse event during trial SP709 (NCT00243217) which is ongoing at the end of that trial and is assessed to be related to the study medication by the investigator and/or the Sponsor
- •Sleep disturbances
- •Further clinically relevant concomitant diseases such as polyneuropathy, akathisia, claudication, varicosis, muscle fasciculation, painful legs and moving toes, or radiculopathy
- •Other central nervous diseases
- •One psychotic episode since start of study SP709
- •Any medical or psychiatric condition, which in the opinion of the investigator can jeopardize or would compromise the subject's ability to participate in this trial
- •Clinically relevant cardiac dysfunction and arrhythmias
- •The subject has at entry in study SP710, a QTc interval ≥ 500 msec and/or a QTc interval which has increased by ≥ 60 msec as compared to the average baseline (Visit 2) QTc interval of study SP709
- •Subject has clinically relevant renal dysfunction (serum creatine ≥ 2.0 mg/dl)
- •Subject has clinically relevant hepatic dysfunction (total bilirubin > 2.0 mg/dl or ALT and/or AST greater than two times the upper limit of the reference range
- •Subject has a newly diagnosed or relapsing neoplastic disease since the start of study SP709
- •Subject has a known hypersensitivity to any components of the trial medication or comparative drugs as stated in this protocol
- •Subject needs drugs prohibited in the course of this trial: neuroleptics, bupidine, hypnotics, antidepressants, anxiolytic drugs, anticonvulsive therapy, psychostimulatory drugs, other L-Dopa or dopamine agonist therapy, opioids, benzodiazepines, MAO inhibitors, sedative antihistamines, amphetamines
- •Subject is abusing alcohol or drug since start of SP709
- •Subject is pregnant or nursing or woman of child-bearing potential who is not surgically sterile, two years postmenopausal, or does not practice two combined methods of contraception, unless sexually abstinent
- •Subject pursues shift work or is subject to other continuous non-disease-related life conditions which do not allow regular sleep at night
- •Subject has clinically relevant vasculopathies (eg, varix or arteriosclerosis)
- •Subject has significant skin hypersensitivity to adhesive or other transdermals or recent unresolved contact dermatitis
- •Subject has symptomatic orthostatic hypotension, or a systolic blood pressure (SBP) less tham 105mmHg and/or a drop in SBP of > 20mmHg or a drop of > 10mmHg in diastolic BP (DBP) on standing at baseline visit (Visit 1)
研究组 & 干预措施
Rotigotine
Experimental
Rotigotine trans-dermal patch
干预措施: Rotigotine (Drug)
结局指标
主要结局
Number of Subjects With at Least One Adverse Event, as Reported Spontaneously by the Subject or Observed by the Investigator, During the 5-year Open-label Extension.
时间窗: Up to five years
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
次要结局
- Number of Subjects Who Withdrew From the Trial Due to an Adverse Event During the 5-year Open Label Extension(Up to five years)
研究者
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