EUCTR2006-003732-30-PL进行中（未招募）不适用
Transdermal Use of Lisuride in Early Parkinson´s Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - TULEP 1
euroBiotec Pharma AG0 个研究点目标入组 350 人开始时间: 2008年1月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 350
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
- •Male or female outpatients
- •Age of > 30 years
- •Newly diagnosed early-stage of idiopathic Parkinson’s disease for longest 1 year (diagnosis based on the UK Brain Bank Criteria)
- •No previous Levodopa therapy (except challenge of diagnosis).
- •Minimum UPDRS motor score of > 12 points.
- •Mini Mental State Examination (MMSE) score of = 27.
- •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
- •a) Patient has non-idiopathic PD
- •b) Significant neurological symptoms not accounted for by Parkinson’s disease
- •c) Current diagnosis of epilepsy, history of seizures as an adult, history of stroke, or transitory ischemic attacks (TIA) within one year prior to the screening visit (visit VS)
- •d) history of pallidotomy, thalamotomy, deep brain stimulation or fetal tissue transplantation or other neurosurgery for Parkinson’s disease
- •e) History of or active hallucinations or delusions including drug-induced hallucina-tions, e.g. by dopaminergic therapy
- •f) Treatment with dopamine agonists within 28 days of the baseline visit (BL)
- •g) Pre-treatment with Levodopa (except for diagnostic challenge)
- •h) Pre-treatment during the last 3 months prior to baseline visit 2 or current treatment with MAO-A inhibitors, reserpine, budip-ine, alpha-methyldopa
- •i) Current treatment with CNS active therapy unless the dose has been stable for at least 28 days prior to the baseline visit (BL)
- •j) Current treatment with medications eliminated through the renal tubulus system or which inhibit the active renal tubulus secretion
- •k) History or presence of dementia
- •l) Presence of major depression
- •m) evidence or suspicion of any cardiac valvulopathy or any other cardiac disor-der which would put the patient at risk of clinically relevant arrhythmia and/or myocardial infarction, within the last 12 months
- •n) Clinically relevant hepatic dysfunction
- •o) Clinically relevant renal dysfunction
- •p) History of syncope and/or severe otherwise symptomatic orthostatic hypotension within the last year or a systolic blood pressure less than 105 mmHg at Screening Visit VS
- •q) History of significant skin hypersensitivity to adhesive or other transdermal applications, or recent unresolved contact dermatitis
- •r) Any medical or psychiatric condition or any other clinically significant laboratory abnormalities that, in the opinion of the investigator, would interfere with the ap-propriate conduct of the study
- •s) Alcohol or drug abuse in the past three years
- •t) Females of childbearing potential who are planning to become pregnant, who are pregnant or lactating and/or who are unwilling to use effective means of contracep-tion
- •u) Patient has previously participated in this trial or patient has previously been as-signed to treatment in a trial with Lisuride TTS
- •v) Participation in other clinical studies in the previous four weeks
- •w) Pregnancy or lactation
- •x) QTc > 470 ms at Visit 1 (Bazett correction must be used)
- •y) Known hypersensitivity to Pramipexole and/or Lisuride
- •z) Creatinine clearance estimated according to Cockroft and Gault < 30 ml/min
研究者
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