EUCTR2006-006752-35-IT进行中（未招募）不适用
PHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON S DISEASE - RECOVER
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 336
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 his/her participation and has given his/her written informed consent. 2. Subject is willing and able to comply with all trial requirements. 3. Subject is male or female, 8805; 18 years of age. 4. Subjects with idiopathic Parkinson s disease Hoehn and Yahr Stage I-IV as defined by the cardinal sign, bradykinesia, and at least one of the following resting tremor, rigidity, or impairment of postural reflexes. 5. Subject has unsatisfactory control of early morning motor impairment as determined by the investigator. 6. If subject is taking levodopa, he/she must be on a stable dose of levodopa in combination with benserazide or carbidopa for at least 28 days prior to the Baseline visit. 7. If the subject is receiving an anticholinergic agent eg, benztropine, trihexyphenidyl, parsitan, procyclidine, biperiden , a monoamine oxidase B 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 trial. 8. Subject must understand the investigational nature of the trial and be willing and able to comply with the trial requirements.
- •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 previously participated in a trial with rotigotine or has experienced treatment failure with commercially available rotigotine. 2. Subject has participated in another trial of an investigational drug within the last 28 days or is currently participating in another trial of an investigational drug. 3. Subject discontinued from previous therapy with a dopamine agonist after an adequate length of treatment at an adequate dose due to lack of efficacy as assessed by the investigator. 4. Subject has had prior therapy with a dopamine agonist within 28 days prior to Baseline. 5. Subject is receiving therapy with controlled-release levodopa within 28 days prior to baseline or is receiving therapy with tolcapone. 6. Subject is receiving therapy with one of the following drugs either concurrently or within 28 days prior to Visit 2 alpha-methyl dopa, metoclopramide, reserpine, neuroleptics except specific atypical neuroloeptics , monoamine oxidase A MAO-A inhibitors, methylphenidate, or amphetamine. 7. Subject has a history of symptomatic not asymptomatic orthostatic hypotension in the 6 months prior to baseline. 8. Subject has atypical Parkinsonian syndromes including drug-induced Parkinsonian syndromes . 9. Subject has a history of atopic eczema and/or active skin disease, such as atopic eczema. 10. Presence of dementia, active psychosis, or hallucinations not due to antiparkinsonian medication . 11. Subject is receiving CNS therapy eg, sedatives, hypnotics, selective serotonin reuptake inhibitors SSRIs , anxiolytics, other sleep-modifying medication unless dose has been stable daily for at least 28 days prior to baseline and is likely to remain stable for the duration of the trial. 12. Subject has a history of seizures or stroke within 1 year, or a history of myocardial infarction within the last 6 months prior to enrollment. 13. Subject has neoplastic disease requiring therapy within 12 months prior to enrollment. 14. Presence of clinically relevant hepatic dysfunction. 15. Presence of clinically relevant renal dysfunction. 16. Evidence of clinically relevant cardiovascular disorders. 17. Subject has a QTcB interval of 61619;500msec at Screening or Baseline Visit 1 or 2; repeated measurements within 1 hour . 18. Subject has a history of chronic alcohol or drug abuse within the last 6 months. 19. Subject has clinically significant laboratory results that, in the opinion of the investigator, would make the subject unsuitable for entry into the trial. 20. Subject is pregnant or nursing, or is of child bearing potential but i not surgically sterile, or, ii not using adequate birth control methods or, iii not sexually abstinent, or iv subject is not at least two years post menopausal. 21. Subject has any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject s ability to participate in this trial. 22. Subject has a known hypersensitivity to any components of the trial medication stated in this protocol. 23. Subject has a previous diagnosis of narcolepsy, sleep apnea syndrome, rapid eye movement REM behavior disorder, restless legs syndrome, or periodic limb movement disorder.
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