EUCTR2005-004290-19-DE进行中（未招募）不适用
A double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's disease
Schwarz Biosciences GmbH0 个研究点目标入组 100 人开始时间: 2005年12月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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 has been 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 aged =30 years.
- •4. Subject has idiopathic Parkinson disease, of more than 3 years in duration, as
- •defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the
- •following: resting tremor, rigidity, impairment of postural reflexes, and without
- •any known or suspected cause of Parkinsonism.
- •5. The investigator must observe the subject in both the on” and off” state and
- •determines that the subject is Hoehn and Yahr stage II -IV in both the on”
- •and off” state.
- •6. Subject has a Mini Mental State Examination (MMSE) score of = 25.
- •7. Subject is expected to be on a stable dose of levodopa, either short-acting or
- •sustained release (in combination with benserazide or carbidopa) for at least 28
- •days prior to baseline (Visit 2) of at least 300mg/day, administered in at least 3
- •8. Subject experiences end-of-dose off” episodes despite attempts to optimize
- •levodopa regimen.
- •9. Subject has a UPDRS Part III in off” state of at least 25 points.
- •10. If the subject is receiving a dopamine agonist, entacapone, an anticholinergic
- •agent (eg, benztropine, trihexyphenidyl, parsitan, procyclidine, biperiden), a
- •monoamine oxidase (MAO) - B inhibitor (eg, selegiline, rasagiline), or a N-methyl-
- •D-aspartate (NMDA) -antagonist (eg, amantadine), he/she is expected to be on
- •a stable dose for at least 28 days prior to baseline (Visit 2).
- •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 this trial or was assigned to treatment with
- •rotigotine in a previous trial.
- •2. Subject has participated in another trial of an investigational drug (or a medical
- •device) within the last 30 days or is currently participating in another trial of an
- •investigational drug (or a medical device).
- •3. Subject has atypical Parkinson syndrome(s), symptomatic Parkinson syndrome(s)
- •due to drugs (eg metoclopramide, flunarizine), metabolic neurogenetic disorders
- •(eg, Wilson disease), encephalitis, cerebrovascular disease or neurodegenerative
- •disease (eg progressive supranuclear palsy).
- •4. Subject has a history of pallidotomy, thalamotomy, deep brain stimulation or fetal
- •tissue transplant.
- •5. Subject has dementia, active hallucinations or active or treated psychosis. If
- •subjects has hallucinations, he/she may participate if hallucinations are treated,
- •and no symptoms occurred during the last 28 days.
- •6. Subject is receiving therapy with any of the following drugs currently or has done
- •so within 3 months prior to the hospital admission visit (Visit 2): MAO-A inhibitors
- •(pargyline, phenelzine and tranylcypromine), tolcapone, budipine, reserpine or
- •alpha-methyldopa.
- •7. Subject is currently receiving CNS active therapy (eg, sedatives, hypnotics, anti-
- •depressants, anxiolytics, atypical neuroleptics), unless the dose has been stable
- •for at least 28 days prior to Visit 2 and is likely to remain stable until end of Visit 3.
- •8. Subject has a current diagnosis of epilepsy, a history of seizures as an adult, a
- •history of stroke or had a TIA within 1 year prior to Visit 1.
- •9. Subject has clinically relevant hepatic dysfunction (as defined as a total bilirubin
- •> 2.0mg/dL or ALT and/or AST greater than 2 times the upper limit of the
- •reference range at Visit 1).
- •10. Subject has clinically relevant renal dysfunction (serum creatinine > 2.0mg/dL
- •[>178µmol/L] at Visit 1).
- •11. Subject has clinically relevant cardiac dysfunction (any cardiac disorder which in
- •the opinion of the investigator would put the subject at risk of clinically relevant
- •arrhythmia) and/or myocardial infarction within 1 year prior to Visit 1.
- •12. Subject has a QTc interval of = 500ms at Visit 1 (the Bazett's correction must be
- •used for the correction of the QT interval).
- •13. Subject has symptoms of rhinitis or local disease or irritation of the nasal mucosa
- •at Visit 2 or Visit 3.
- •14. Subject has had intra-nasal treatment within 14 days prior to Visit 3.
- •15. Subject has a history of symptomatic orthostatic hypotension, or systolic blood
- •pressure less than 105mmHg at trial entry.
- •16. Subject has a history of chronic alcohol or drug abuse within the last 6 months.
- •17. Subject has a known or suspected hypersensitivity to any component of the
- •investigational product or other nasal spray products.
- •18. Subject is pregnant or nursing, or is of child bearing potential but (i) not
- •surgically sterile or (ii) not using adequate birth control methods (including a
- •highly effective method of birth control and at least 1 barrier method) or (iii) not
- •sexually abstinent or (iv) subject is not at least 2 years post-menopausal
- •19. Subject has any medical condition, psychiatric condition or laboratory abnormality
- •that, in the opinion of the investigator, could jeopardize or would compromise
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