EUCTR2004-002609-66-DE进行中（未招募）不适用
A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson's disease
Schwarz Biosciences GmbH0 个研究点目标入组 60 人开始时间: 2005年4月22日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
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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.
- •- Subject has idiopathic early-stage Parkinson's disease (Hoehn & Yahr Stage I-III;
- •see Section 15.9) =5 years in duration, with at least two (2) or more of the
- •following cardinal signs being present: bradykinesia, resting tremor, rigidity,
- •postural instability; and without any other known or suspected cause of
- •Parkinsonism.
- •- Subject has a UPDRS motor score (part III) of =10 at baseline (Visit 2)
- •- Subject has unsatisfactory control of early morning motor impairment as
- •determined by the investigator.
- •- 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 trial.
- •Are the trial subjects under 18?
- •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 levodopa within 28 days prior to baseline or is
- •receiving therapy with entacapone or tolcapone; subject has received levodopa for
- •more than 6 months since diagnosis.
- •- Subject is receiving therapy with one of the following drugs either concurrently or
- •within 28 days prior to Visit 2: dopamine agonists, alpha-methyl dopa,
- •metoclopramide, reserpine, budipine, neuroleptics (including atypical), MAO-A
- •inhibitors, methylphenidate, amphetamine, or central dopamine antagonists.
- •- 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.
- •- Subject has 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 12 months prior to enrollment, or
- •has had a TIA within 12 months prior to enrollment, or has a history of myocardial
- •infarction within the last 6 months prior to enrollment.
- •- Subject has malignant neoplastic disease requiring therapy within 12 months prior
- •to enrollment.
- •- Subject has clinically relevant hepatic dysfunction.
- •- Subject has clinically relevant renal dysfunction.
- •- Subject has 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 relevant 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 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) subject is not at least 2 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 history of significant skin hypersensitivity to adhesive or other
- •transdermals or recent unresolved contact dermatitis or has a known allergy or
- •hypersensitivity to ropinirole.
- •- Subject has a previous diagnosis of narcolepsy, sleep apnea syndrome, rapid eye
- •movement (REM) behavior disorder, restless legs syndrome, or periodic limb
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