EUCTR2004-002598-21-GB进行中（未招募）1 期
A phase 3b, open-label. multicenter, multinational trial to evaluate the effects of rotigotine transdermal patch on early morning motor impairment and sleep disorders in patients with idiopathic Parkinson's disease
Schwarz Biosciences GmbH0 个研究点目标入组 50 人开始时间: 2005年7月7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
- 50
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
- •- Subject is informed and given ample time and opportunity to think about his/her
- •participation and has given his/her written informed consent.
- •- Subject is willing and able to comply with all trial requirements.
- •- Subject is male or female, =18 years of age and - Subjects with idiopathic Parkinson's disease (Hoehn and Yahr Stage I-IV; see
- •Section 15.9) as defined by the cardinal sign, bradykinesia, and at least one of the
- •following: resting tremor, rigidity, or impairment of postural reflexes.
- •- Subject has unsatisfactory control of early morning motor impairment as
- •determined by the investigator.
- •- 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.
- •- 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
- •- 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
- •- Subject has previously participated in a trial with rotigotine.
- •- 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.
- •- 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.
- •- Subject has had prior therapy with a dopamine agonist within 28 days prior to
- •- Subject is receiving therapy with controlled-release levodopa within 28 days prior
- •to baseline or is receiving therapy with tolcapone.
- •- 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 (including atypical), monoamine oxidase A (MAO-A) inhibitors,
- •methylphenidate, or amphetamine.
- •- Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension in
- •the 6 months prior to baseline.
- •- Subject has atypical Parkinsonian syndromes (including drug-induced Parkinsonian
- •syndromes).
- •- Subject has a history of atopic eczema and/or active skin disease, such as atopic
- •- Presence of dementia, active psychosis, or hallucinations (not due to
- •antiparkinsonian medication).
- •- 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.
- •- 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.
- •- Subject has neoplastic disease requiring therapy within 12 months prior to
- •enrollment.
- •- Presence of clinically relevant hepatic dysfunction.
- •- Presence of clinically relevant renal dysfunction.
- •- Evidence of clinically relevant cardiovascular disorders.
- •- Subject has a QTcB interval of =500msec at Screening or Baseline (Visit 1 or 2;
- •repeated measurements within 1 hour).
- •- Subject has a history of chronic alcohol or drug abuse within the last 6 months.
- •- Subject has clinically significant laboratory results that, in the opinion of the
- •investigator, would make the subject unsuitable for entry into the trial.
- •- 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 at least one
- •barrier method) or, (iii) not sexually abstinent, or (iv) subject is not at least two
- •years post menopausal.
- •- 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.
- •- Subject has a known hypersensitivity to any components of the trial medication
- •stated in this protocol.
- •- 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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