EUCTR2005-000428-18-DE进行中（未招募）不适用
A mulit-center, randomized, double-blind, placebo-controlled, four-arm parallel group trial to investigate the efficacy and safety of three different transdermal doses of rotigotine in subjects with idiopathic restless legs syndrome
Schwarz Biosciences GmbH0 个研究点目标入组 450 人开始时间: 2005年4月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subject is informed and given ample time and opportunity to think about her/his
- •participation and has given her/his written informed consent.
- •2. Subject understands the investigational nature of the trial and is willing and able
- •to comply with the trial requirements. Subject is willing to accept that he/she
- •might be treated with placebo during the treatment period.
- •3. Subject is able to apply/remove the trial patches correctly and consistently.
- •4. Subject is male or female, and is =18 and =75 years of age.
- •5. Subject meets the diagnosis of idiopathic RLS based on the 4 cardinal clinical
- •features according to the IRLSSG:
- •a. An urge to move legs, usually accompanied or caused by uncomfortable and
- •unpleasant sensations in the legs (The urge to move can be present without
- •uncomfortable sensations. Arms or other body parts can also be affected.).
- •b. The urge to move or unpleasant sensations begin or worsen during periods
- •of rest or inactivity such as lying or sitting.
- •c. The urge to move or unpleasant sensations are partially or totally relieved by
- •movement, such as walking or stretching, at least as long as the activity
- •d. The urge to move or unpleasant sensations are worse in the evening or night
- •than during the day or only occur in the evening or night (When symptoms
- •are very severe, the worsening at night may not be noticeable but must have
- •been previously present.).
- •6. Subject has had an initial response to previous dopaminergic treatment for RLS or
- •has had no previous dopaminergic treatment (ie, de novo).
- •7. The subject’s body mass index is =18kg/m2 and =35kg/m2.
- •8. At Baseline (Visit 2), subject has a score of =15 on the IRLS (indicating moderate
- •to severe RLS).
- •9. At Baseline (Visit 2), subject scores =4 points on the CGI Item 1 assessment
- •(indicating at least moderately ill).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subject has secondary RLS (eg, due to renal insufficiency [uremia], iron
- •anemia, or rheumatoid arthritis).
- •2. Subject has secondary RLS associated with previous or concomitant therapy with
- •dopamine D2 receptor antagonists, butyrophenones, metoclopramide, atypical
- •antipsychotics (eg, olanzapine), tri- and tetra-cyclic antidepressants, mianserine,
- •lithium, or due to withdrawal from drugs such as anticonvulsants,
- •benzodiazepines, barbiturates, and other hypnotics.
- •3. Subject has a current history of sleep disturbances like sleep apnea syndrome,
- •narcolepsy, sleep attacks/sudden onset of sleep, or myoclonus epilepsy either
- •observed during polysomnography or evidenced by subject history.
- •4. Subject has additional clinically relevant concomitant diseases such as
- •polyneuropathy, akathisia, claudication, varicosis, muscle fasciculation, painful
- •legs and moving toes, or radiculopathy.
- •5. Subject has other central nervous system diseases such as Parkinson’s disease,
- •dementia, progressive supranuclear paresis, multisystem atrophy, Huntington’s
- •Chorea, amyotrophic lateral sclerosis, or Alzheimer’s disease.
- •6. Subject has a prior history of psychotic episodes.
- •7. Subject has a history of chronic alcohol or drug abuse within the last 12 months.
- •8. Subject has 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.
- •9. Subject has clinically relevant cardiac dysfunction and/or arrhythmias (eg,
- •suspected conduction system dysregulations, second or third degree AV block,
- •complete left or right bundle branch block, sick-sinus-syndrome, New York Heart
- •Association Class III or IV congestive heart failure, or has had a myocardial
- •infarction within 12 months prior to Screening [Visit 1]).
- •10. Subject has clinically relevant venous or arterial peripheral vascular disease.
- •11. Subject has clinically relevant renal dysfunction (serum creatinine >2.0mg/dL)
- •12. Subject has clinically relevant hepatic dysfunction (total bilirubin >2.0mg/dL or
- •alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater
- •than 2 times the upper limit of the reference range).
- •13. Subject has a malignant neoplastic disease requiring therapy within 12 months
- •prior to Screening (Visit 1).
- •14. Subject is currently receiving treatment with any of the following drug classes:
- •neuroleptics, hypnotics, antidepressants, anxiolytic drugs, anticonvulsive
- •therapy, opioids, benzodiazepines, monoamine oxidase (MAO) inhibitors,
- •catechol-O-methyl-transferase (COMT) inhibitors, sedative antihistamines,
- •psychostimulates, or amphetamines. If subject has received such therapy, a
- •washout period of at least 7 days prior to Baseline (Visit 2) is required before
- •starting treatment in this trial.
- •15. Subject is pregnant, nursing, or is a woman of child-bearing potential who is not
- •surgically sterile, 2 years postmenopausal, or does not consistently use 2
- •combined effective methods of contraception (including at least 1 barrier
- •method), unless sexually abstinent.
- •16. Subject pursues shift work or performs other continuous non-disease-related life
- •conditions which do not allow regular sleep at night.
- •17. Subject has a QTc interval of =500ms a
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