EUCTR2006-005186-18-PT进行中（未招募）不适用
An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications”
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 320
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. Diagnosis of idiopathic PD according to the United Kingdom Parkinson’s Disease Society (UKPDS) Brain Bank Criteria;
- •2. The subjects’ advanced PD must be the levodopa-responsive type as
- •judged by the Investigator. Additionally, subjects will need to demonstrate severe
- •persistent motor fluctuations in spite of individually optimized available treatment, and where other therapy options are indicated;
- •3. Subjects have had optimal treatment with available PD medication as defined by local standards of care and, based upon the judgment of the Investigator, and their symptoms are judged inadequately controlled on this optimized treatment. Optimized treatment is defined as the maximum therapeutic effect obtained with pharmcological antiparkinsonian therapies when no further improvement is expected regardless of any additional manipulations of levodopa and/or other antiparkinsonian medication; this will be based on the Investigator’s best clinical judgment;
- •4. Presence of a recognizable off” and on” state (motor fluctuations) as confirmed by the symptom diary at baseline (diaries are collected for the threedays preceding the baseline visit);
- •5. Subjects (or subject’s proxy) must be able to keep a subject diary of off” time and
- •dyskinesia;
- •6. Subjects must be experiencing a minimum of three hours per day of off” time, as estimated by the Investigator and supported by the UPDRS and the diaries. The off” time must occur during a continuous 16-hour interval, including the portion of the day which the subject is awake the majority of the time (e.g. 5 AM to 9 PM, 7 AM to 11 PM;
- •7. The subject must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study procedures (including any changes occurring in the subject’s current therapeutic regimen);
- •8. Subjects must be able to speak, read, understand and possess the ability to respond to and follow simple instructions. For a subject to be eligible all required documents, including the informed consent, must be available in a language which is understandable to the subject;
- •9. Male or female subjects aged at least 30 years;
- •10. Females who are not breast-feeding or are of non-childbearing potential. All females of child bearing potential must have a negative serum beta-human chorionic gonadotropin (ß-HCG) test prior to study entry.
- •Non-childbearing is defined as:
- •- last natural menstruation at least 24 months prior to baseline or
- •- surgically sterilized (i.e. tubal sterilization) at least three months prior to baseline or
- •- total hysterectomy at least three months prior to baseline.
- •11. A female subject of child-bearing potential may be enrolled provided that she is
- •maintained on one of the following medically acceptable methods of birth control (a stable dose of contraceptive drug for at least three months or barrier methods: intra-uterine device, diaphragm, combination of a condom and spermicide)
- •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
- •Subjects meeting any of the exclusion criteria listed below either at screening and/or baseline must be excluded from participation in the study.
- •1. PD Diagnosis is unclear or a suspicion of other Parkinsonian syndromes exists, such as secondary Parkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson-plus syndromes (e.g., multiple system atrophy, progressive supranuclear palsy) or the other neurodegenerative diseases;
- •2. Subjects who have undergone surgery for the treatment of PD (e.g., pallidotomy, deep brain stimulation, fetal tissue transplantation);
- •3. Subjects with any neurological deficit that might interfere with the study assessments (e.g. hemiparesis); and/or any subjects diagnosed with an acute stroke within the six months prior to Baseline;
- •5. Known hypersensitivity to levodopa, carbidopa or radiopaque material;
- •6. Contraindications to levodopa, such as narrow angle glaucoma, hyperthyroidism, pheochromocytoma, Cushing’s syndrome and history of malignant melanoma;
- •7. Subjects who are experiencing sleep attacks (Section 8.1.1.1); or who exhibit clinically
- •significant impulsive behavior (e.g. pathological gambling, hypersexuality) during the
- •three months prior to the screening evaluation;
- •8. Current diagnosis or history of drug or alcohol abuse (Diagnostic and Statistical Manual
- •of Mental Disorders [DSM]-IV-TR criteria) within 12 months prior to the screening visit;
- •9. Current primary psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses, such as bipolar disorder or major depressive disorder (DSM-IV-TR criteria);
- •10. Psychiatric, neurological or behavioral disorders that may interfere with the ability of subjects to give informed consent, or interfere with the conduct or interpretation of the study; troublesome hallucinations would also be included under this category;
- •11. Alzheimer’s disease; or other significant cognitive impairment or dementia (defined as Mini-Mental State Examination [MMSE] <24);
- •12. Clinically significant abnormal laboratory data (e.g., aspartate aminotransferase [AST] or alanine aminotransferase [ALT] 3 x ULN) or any other abnormal laboratory value that could interfere with the assessment of safety in the judgment of the Investigator;
- •13. Current evidence of clinically significant hematological, autoimmune, endocrine, cardiovascular, renal or gastrointestinal disorder that would possibly interfere with the subject’s participation in the study (e.g., treated, controlled and thus stable hypertension is not considered an exclusion criterion);
- •14. A history of, or a known current gastrointestinal, liver, kidney or other known condition, which may interfere with the absorption, distribution, metabolism or excretion of the study medication and/or assessments, or interfere with the insertion of the tubing system (e.g., subjects who have undergone gastric or intestinal surgery other than, for instance, appendectomy or cholecystectomy);
- •15. Any malignant disease or a history of neoplasms, other than carcinoma in situ of the cervix or basal cell carcinoma of the skin, within the past five years prior to screening; Additionally, subjects with prostate cancer may be considered for enrollment in the study following a comprehensive assessment and a discussion between the Investigator and the Medical Monitor regarding the appropriateness of the subject for the study;
- •16. Medical, laboratory or surgical issues deemed by the
研究者
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