EUCTR2004-002650-59-GB进行中（未招募）1 期
A phase 3b, open-label, multicentre, multinational trial to assess the tolerability of switching subjects from ropinerole, pramipexole or cabergoline to the rotigotine transdermal system and its effect on symptoms with idiopathic Parkinson's disease - n/a
SCHWARZ BIOSCIENCES0 个研究点目标入组 130 人开始时间: 2005年6月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 130
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, aged greater than or equal to 18 years
- •4. Subjects with idiopathic Parkinson's disease (Hoehn and Yahr stage I-IV), as defined by cardinal sign, bradykinesia and at least one of the following: resting tremor, rigidity or impairment of postural reflexes
- •5. Subject is not satisfactorily controlled on a total daily dose of ropinirole up to 9.0mg, pramipexole up to 2.0mg or cabergoline up to 3.0mg
- •6. If the subject is receiving levodopa, either short-acting or sustained-release (in combination with benzserazide or carbidopa), the total daily dose must be stable for 28 days prior to the baseline visit and must remain stable for the duration of the trial
- •7. If the subject is receiving an anticholinergic agent (e.g. benztropine, trihexypheniyl, parsitan, procyclidine, biperiden), a monoamine oxidase B (MAO-B) inhibitor (e.g. selegiline), or an N-methyl-d-aspartate (NMDA) antagonist (e.g. 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
- •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
- •2. Subject has previously participated in another trial of an investigational drug
- •3. Subject has atypical Parkinson's syndrome(s), including drug-induced Parkinsonian syndrome
- •4. Subject has dementia, active psychosis or hallucinations (not due to antiparkinsonian medication)
- •5. Subject is receiving therapy with one of the following drugs either concurrently or within 28 days prior to the baseline visit: alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (including atypical), MAO-A inhibitors, methylphenidate or amphetamine
- •6. Subject is currently receiving CNS active therapy (e.g. sedatives, hypnotics, anti-depressants, antiolytics)
- •7. Subject has a history of seizures or stroke within 1 year, has had a TIA within 12 months prior to enrolment, or a history of myocardial infarction within the last 6 months prior to enrolment
- •8. Presence of clinically relevant hepatic dysfunction
- •9. Presence of clinically relevant renal dysfunction
- •10. Evidence of clinically relevant cardiovascular disorders
- •11. Subject has QTcB interval of greater than or equal to 500msec at pretreatment or baseline (repeated measurements within 1 hour)
- •12. Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension in the 6 months prior to baseline
- •13. Subject has a history of significant skin hypersensitivity to adhesive or other transdermals or recent unresolved contact dermatitis
- •14. Subject has malignant neoplastic disease requiring therapy within 12 months prior to enrolment
- •15. Subject has a history of chronic alcohol or drug abuse within the last 6 months
- •16. Subject has clinically significant laboratory results that, in the judgement of the investigator, would make the subject unsuitable for entry into the trial
- •17. Subject is pregnant or nursing, or is of childbearing potential but (i) not surgically sterile or (ii) not using adequate birth control methods (including at least one barrier method), or (iii) not sexually abstinent or (iv) not at least 2 years postmenopausal
- •18. Subject has any other clinically significant medical or psychiatric condition that would, in the opinion of the investigator, interfere with the subject's ability to participate in the trial
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