EUCTR2006-003732-30-IT进行中（未招募）不适用
Transdermal Use of Lisuride in Early ParkinsonŽs Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - Tulep I
EUROBIOTEC GMBH0 个研究点目标入组 350 人开始时间: 2008年2月13日最近更新:
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
- •a)Patient is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent
- •b)Patient is willing and able to comply with all trial requirements
- •c)Male or female outpatients
- •d)Age > 30 years
- •e)Patients with newly diagnosed early-stage of idiopathic Parkinson?s disease for longest 1 year (diagnosis based on the UK Parkinson Brain Bank Diagnostic Criteria for PD, see Appendix 16.3.8) who have not yet received Levodopa therapy (except Levodopa test)
- •f)Minimum UPDRS motor score of > 12 points at Baseline Visit BL
- •g)Mini Mental State Examination (MMSE) score of ≥ 27
- •h)Concomitant diseases are stable and well controlled by medication
- •i)Female patients must have a negative pregnancy test within 7 days prior to or at Baseline and are required to practice an effective method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility. Effective method of birth control is defined as those which result in a low failure rate (i.e. Pearl Index less than 1% per year) when used consistently and correctly such as:
- •A hormonal oral, transdermal, or injectable contraceptive agent with a double-barrier method
- •An implantable contraceptive device with a failure rate less than 1% for at least 3 months prior to screening
- •Tubal Ligation,
- •Vasoectomized partner
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a)Patient has non-idiopathic PD due to drugs (e.g. flunarizine, metoclopramide), metabolic neurogenetic disoders (e.g., Wilson?s disease), encephalitis, cerebrovascular disease or other forms of secondary or atypical Parkinsonism such as multisystem atrophy (MSA) or progressive supranuclear palsy)
- •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)Patient has a 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 hallucinations, 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 (pargyline, phenelzine, tranylcypromine), reserpine, budipine, alpha-methyldopa
- •i)Current treatment with CNS active therapy (e.g., sedatives, hypnotics, anti-depressants, anxiolytics, antipsychotics) unless the dose has been stable for at least 28 days prior to the baseline visit (BL) and is likely to remain stable for the duration of Part A of the study.
- •j)Current treatment with medications which will be eliminated through the renal tubulus system or which inhibit the active renal tubulus secretion (e.g., cimetidine, amantadine)
- •k)History or presence of dementia demonstrated by the Mini-mental status examination or clinically
- •l)Presence of major depression according to DSM IV criteria
- •m)Any evidence or suspicion of any cardiac valvulopathy or any other cardiac disorder which in the opinion of the investigator would put the patient at risk of clinically relevant arrhythmia and/or myocardial infarction, within the last 12 months
- •n)Clinically relevant hepatic dysfunction as defined as total bilirubin > 2.0 mg/dl or ALT and/or AST greater than two times the upper limit of normal range
- •o)Clinically relevant renal dysfunction as defined as creatinine > 2.0 mg/dl (> 178 μmol/l)
- •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 appropriate 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 contraception
- •u)Patient has previously participated in this trial or patient has previously been assigned 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)
研究者
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