EUCTR2011-000056-42-GB进行中（未招募）不适用
A MULTI-CENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFECTS OF ROTIGOTINE ON SLEEP EFFICIENCY IN PATIENTS WITH ADVANCED PARKINSON’S DISEASE - sleep efficiency assessed by polysomnography in advanced Parkinson's Disease
CB Celltech, UK - Registered Branch of UCB Pharma SA0 个研究点开始时间: 2011年8月11日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written Informed Consent form (ICF) is signed and dated by the subject.
- •2. Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication application according to the judgment of the investigator.
- •3. Subject is male or female, =18 years of age.
- •4. Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence only is not an acceptable method. Subjects must agree to use adequate contraception during the study and for 4 weeks after their final dose of rotigotine (or longer, if required by local regulations).
- •5. Subject has advanced Parkinson’s disease (ie, takes levodopa [L-DOPA]) and has been on a stable dose of L-DOPA (in combination with either benserazide or carbidopa) for at least 28 days prior to the Baseline Visit.
- •6. Subject has a Hoehn and Yahr stage score of 2 to 4.
- •7. Subject has sleep-maintenance insomnia (PDSS2 item 3=often” or 4=very often”).
- •8. If the subject is receiving an anticholinergic agent (eg, benztropine, trihexyphenidyl, parsitan, procyclidine, biperiden), a monoamine oxidase (MAO)-B inhibitor (eg, selegiline), or an N-methyl-D-aspartate (NMDA) antagonist (eg, amantadine), he/she
- •must have been on a stable dose for at least 28 days prior to the Baseline Visit and must be maintained on that dose for the duration of the study.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Subject has previously participated in this study or subject has previously been assigned to treatment in a study of the medication under investigation in this study.
- •2. Subject has participated in another study of an IMP or a medical device within the previous 30 days, or is currently participating in another study of an IMP or a medical device.
- •3. Subject has a history of chronic alcohol or drug abuse within the previous year.
- •4. Subject has any medical or psychiatric condition (eg, severe hallucinations or psychosis) that, in the opinion of the investigator, could jeopardize or would compromise the subject’s well being or ability to participate in this study.
- •5. Subject has a known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol.
- •6. Subject has a significant skin disease that would make transdermal drug use inappropriate, including a history of skin sensitivity to adhesives or transdermal medications.
- •7. Subject received therapy with controlled-release L-DOPA, entacapone, or Stalevo® within 28 days prior to the Baseline Visit or has ever received therapy with tolcapone.
- •8. Subject discontinued from previous therapy with a DA after an adequate length of treatment, at an adequate dose, due to lack of efficacy as assessed by the investigator.
- •9. Subject has had prior therapy with a DA within 28 days prior to the Baseline Visit.
- •10. Subject is receiving therapy with 1 of the following drugs, either concurrently or within 28 days prior to the Baseline Visit: alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, and quetiapine), MAO-A inhibitors, methylphenidate, or amphetamine.
- •11. Subject is receiving central nervous system (CNS) therapy (eg, sedatives, hypnotics, selective serotonin reuptake inhibitors [SSRIs], anxiolytics, or other sleep-modifying medication [eg, modafinil]), unless dose has been stable daily for at least 28 days prior to the Baseline Visit and is likely to remain stable for the duration of the study.
- •12. Subject has atypical Parkinsonian syndromes (including drug-induced Parkinsonian syndromes).
- •13. Subject has a history of seizures or stroke within 1 year or a history of myocardial infarction within 6 months prior to enrollment (ie, the date of signing the ICF).
- •14. Subject has evidence of an impulse control disorder (ICD) according to a positive modified Minnesota Impulsive Disorders Interview (mMIDI), and a diagnosis of ICD confirmed by a structured interview at Screening (Visit 1). If the subject refuses the structured interview after a positive module on the mMIDI, the subject is excluded from study participation.
- •15. Subject has evidence of significant cognitive impairment with a Mini Mental State Examination (MMSE) score of less than 25 at Screening (Visit 1).
- •16. Subject’s condition has previously been diagnosed as narcolepsy, sleep apnoea syndrome, significant REM Sleep Behavior disorder (RBD), moderate to severe RLS as assessed by the International Restless Legs Scale (IRLS), or periodic limb movement disorder.
- •17. Subject is pregnant or lactating.
- •18. Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (‘yes’) to either Question 4 or Question 5 of the C
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