EUCTR2009-010193-38-EE进行中（未招募）不适用
A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 350
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. Able to understand and willing to voluntarily sign an informed consent form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) authorization or local equivalent if applicable.
- •2. Diagnosed with idiopathic PD as defined by meeting United Kingdom Parkinson’s Disease Society Brain Bank Diagnostic Criteria without any known cause for Parkinsonism.
- •3. Male or female at least 30 years old at the time of PD diagnosis.
- •4. Hoehn and Yahr Staging I, II, or III.
- •5. Mini-Mental State Exam (MMSE) = 26 at Screening.
- •6. LD-naïve: defined as subjects not exposed to LD or catechol-O-methyl transferase inhibitors for more than 30 days and the exposure is not within 4 weeks prior to study enrollment.
- •7. The sum of UPDRS Parts II and III scores = 18 at Screening and Baseline.
- •8. If currently taking anticholinergic therapy, amantadine, or a monoamine oxidase type B (MAO-B) inhibitor, maintains a stable regimen for at least 4 weeks prior to Baseline, and agrees to maintain the stable regimen throughout study participation.
- •9. Agrees to use a medically acceptable method of contraception throughout the study and for 1 month after completing the study. Medically acceptable methods of contraception that may be used by the subject and/or partner include, but are not limited to, abstinence, oral contraception, NuvaRing® or transdermal systems, diaphragm with vaginal spermicide, intra-uterine device, condom and partner using vaginal spermicide, surgical sterilization (>6 months), progestin implant or injection, or postmenopausal female (no menstrual period for > 2 years) or vasectomy (>6 months).
- •10. Able and willing to comply with the protocol, including availability for all scheduled clinic visits and telephone calls.
- •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
- •1. Pregnant or breastfeeding.
- •2. Diagnosed with atypical Parkinsonism or any known secondary parkinsonian syndrome (e.g., vascular, toxin or medication-induced, metabolic, or infectious) or other neurodegenerative disorder with Parkinsonism (i.e.,progressive supranuclear palsy, corticobasal degeneration, multiple-system atrophy).
- •3. Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) or if such procedures are anticipated during study participation.
- •4. Use of nonselective MAO inhibitors.
- •5. Use of dopamine agonists within 30 days prior to Screening.
- •6. Unable to tolerate a placebo regimen, in the Investigator’s opinion.
- •7. Sensitivity to CD-LD or to IPX066 or its excipients.
- •8. Treatment of psychosis with any antipsychotic, including atypical antipsychotics within the 2 years prior to Screening. Treatment for conditions other than psychosis, such as sleep aid, is allowed.
- •9. History of seizure or epilepsy, or currently taking an anticonvulsant for treatment of seizure disorder.
- •10. Active or prior medical conditions such as peptic ulcers or prior surgical (e.g., bowel) procedure that would interfere with LD absorption.
- •11. History of narrow-angle glaucoma.
- •12. Subjects with a history of malignant melanoma or a suspicious undiagnosed skin lesion, which in the opinion of the Investigator could be melanoma.
- •13. History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome.
- •14. Abnormal kidney function (i.e., serum creatinine level = 1.5 times the upper limit of normal (ULN) at Screening or requires dialysis.
- •15. Liver transaminase values = 2 times the ULN at Screening.
- •16. Received any investigational medications during the 30 days prior to Screening.
- •17. Subjects who, in the opinion of the clinical Investigator, should not participate in the study.
- •18. Employees or family members of the Investigator, study site or the sponsor.
研究者
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