EUCTR2010-021394-37-BG进行中（未招募）不适用
MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976
CB Pharma SA0 个研究点目标入组 345 人开始时间: 2011年6月2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
- 345
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. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
- •approved written informed consent form is signed and dated by the subject or
- •legal representative.
- •2. Subject/legal representative is considered reliable and capable of adhering to the
- •protocol, visit schedule, and medication application according to the judgment of
- •the investigator.
- •3. Subject is male or female, =18 years of age.
- •4. Subject has idiopathic Parkinson’s disease with at least 2 of the following cardinal
- •signs being present: bradykinesia, resting tremor, rigidity or postural instability,
- •and without any other known or suspected cause of Parkinsonism.
- •5. Subject has a Hoehn and Yahr stage score =4.
- •6. Subject has a total NMSS score =40.
- •7. If the subject is receiving anticholinergics, monoamine oxidase (MAO) B inhibitors, or
- •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
- •8. If the subject is taking levodopa (L-DOPA), he/she must be on a stable dose of L
- •DOPA (in combination with benserazide or carbidopa) for at least 28 days prior to
- •the Baseline Visit.
- •9. Female subjects of childbearing potential must agree to use 1 of the following
- •contraceptive methods throughout the course of the study and for 4 weeks after
- •the final removal of study medication:
- •? Oral contraceptives
- •? Intrauterine devices
- •? Double-barrier method
- •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 280
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 65
排除标准
- •1. Subject has previously participated in this study or subject has previously been
- •assigned to treatment in a study of the medication under investigation in this
- •2. Subject has participated in another study of an IMP within 30 days prior to the
- •Screening Period or is currently participating in another study of an IMP.
- •3. Subject has a history of chronic alcohol or drug abuse within the previous year.
- •4. Subject has any medical, psychiatric, or cognitive condition that, in the opinion of
- •the investigator, could jeopardize or would compromise the subject’s well being or
- •ability to participate in this study.
- •5. Subject has a known hypersensitivity to any components of the IMP, including
- •sodium metabisulfite.
- •6. Subject has a significant skin disease that would make transdermal drug use
- •inappropriate, including a history of skin sensitivity to adhesives or transdermal
- •medications.
- •7. 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.
- •8. Subject is receiving therapy with 1 of the following drugs, either concurrently or
- •within 28 days prior to the Baseline Visit: alpha-methyl dopa, metoclopramide,
- •reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine,
- •ziprasidone, aripiprazole, clozapine, and quetiapine), MAO-A inhibitors,
- •methylphenidate, amphetamine, or other dopamine agonists (DAs).
- •9. Subject is receiving central nervous system (CNS) therapy (eg, sedatives,
- •hypnotics, selective serotonin reuptake inhibitors [SSRIs], anxiolytics, or other
- •sleep-modifying medication) unless dose has been stable daily for at least 28
- •days prior to the Baseline Visit and is likely to remain stable for the duration of the
- •10. Subject has evidence of an ICD according to the mMIDI at the Screening Visit
- •(Visit 1), confirmed by a positive structured clinical interview.
- •11. Subject is pregnant or lactating.
- •12. Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening.
研究者
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