EUCTR2007-007853-30-SE进行中（未招募）不适用
A randomized, double-blind, placebo controlled, safety and tolerability study of intracerebroventricular administration of sNN0031 to patients with idiopathic Parkinson's disease (PD) of moderate severity, using an implanted catheter and a SynchroMed® II pump.
euroNova AB0 个研究点开始时间: 2007年12月21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
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
- •- Male or female. Females should either be post-menopausal (at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with FSH levels >40 mIU/mL), be surgically sterilized (bilateral oophorectomy w/o hysterectomy), or use adequate contraception (oral contraceptives, intrauterine device or double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam.) during the duration of the study.
- •- Diagnosis of idiopathic Parkinson's disease (PD) of moderate severity (modified Hoehn & Yahr Stage IIb-III).
- •- Effect duration of oral L-dopa dose intake =4 hours
- •- Score =30 on motor part (part III) of UPDRS at defined off (>12 hours after last dose intake)
- •- Dopaminergic responsiveness with at least 33% decrease in the UPDRS part III score after administration of L-dopa
- •- Disease duration at least 5 years
- •- Age 30 to 75 years
- •- Stable anti-Parkinson treatment for at least 3 months
- •- Ophthalmologic examination with normal findings regarding vascular structure and function
- •- MRI examination of the brain and cervical spinal cord within 3 months before anticipated implantation of the device with no findings of tumors or potential sources of pathological bleedings, or abnormality that may interfere with the assessments of safety or efficacy or would, in the judgment of the investigator, represent a surgical risk to the subject.
- •- Values of coagulation parameters including platelet count, normalized prothrombin complex (PK-INR), activated partial thromboplastin time (APTT) within normal ranges.
- •- The subject is medically able to undergo the surgery required for stereotactic implantation of the catheter and infusion pump.
- •- Has been given written and verbal information, has had opportunity
- •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
- •- Atypical form of PD including repeated head trauma, drug- or toxin-induced PD, and other neurological conditions including Shy-Drager syndrome (multiple system atrophy), progressive supranuclear palsy, Wilson's disease, Huntington's disease, Hallervorden-Spatz syndrome, Alzheimer's disease, Creutzfeldt-Jakob disease, olivopontocerebellar atrophy, and post-traumatic encephalopathy
- •- Concurrent dementia with a score of 20 or lower on the MMT rating scale
- •- Concurrent clinically significant depression with a score of 16 or higher on the MADRS rating scale, equivalent to moderate or severe depression.
- •- Exposure to neuroleptic drugs blocking dopamine receptors within 6 months
- •- History of structural brain disease including tumors and hyperplasia
- •- History of increased intracranial pressure
- •- Prior surgical procedures or implantation of device for the treatment of PD
- •- Prior exposure to any formulation of PDGF-BB (including topical)
- •- Uncontrolled hypertension with blood pressure >160 mmHg systolic or >90 mmHg diastolic.
- •- Any disorder that precludes a surgical procedure (eg, signs of sepsis or inadequately treated infection), alters wound healing (e.g. including bleeding disorders), or renders chronic ICV delivery or device implants medically unsuitable.
- •- Presence of risk for increased or uncontrolled bleeding and/or risk of bleeding that is not managed optimally. Physicians should specifically investigate anatomical factors at or near the implant site (e.g., vascular abnormalities, neoplasms, or other abnormalities), underlying disorders of the coagulation cascade, platelet function, or platelet count (e.g., hemophilia, Von Willebrand's disease, liver disease, or other medical conditions), and the administration of any antiplatelet or anticoagulant medication (e.g., aspirin, Plavix, NSAIDs) in the pre- or perioperative period. Any of those conditions or drugs could place a patient at an increased risk for intraoperative or postoperative bleeding.
- •- Presence of an implanted shunt for the drainage of cerebrospinal fluid (CSF) or an implanted central nervous system (CNS) catheter.
- •- Presence of cardiac pacemakers, spinal cord stimulators, implantable programmable intraspinal drug pumps, or any other device that may interfere or interact with the programmer, without prior approval by Medtronic.
- •- Clinically significant abnormalities in hematology or clinical chemistry parameters as assessed by the investigator
- •- Ongoing medical condition that according to the investigator would interfere with the conduct and assessments in the study. Examples are medical disability (eg, severe degenerative arthritis, compromised nutritional state, peripheral neuropathy) that would interfere with the assessment of safety and efficacy of investigational product or device performance, or would compromise the ability of the subject to undergo study procedures (eg, MRI, PET), or to give informed consent.
- •- Participation in another clinical trial with an investigational drug or device within 3 months prior to Screening visit.
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