EUCTR2009-017238-39-FR进行中（未招募）1 期
A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease
Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)0 个研究点目标入组 56 人开始时间: 2010年7月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 56
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 sign an ICF and Health Insurance Portability and Accountability Act (HIPAA) authorization or local equivalent, if applicable.
- •2. Diagnosed with idiopathic PD meeting United Kingdom Parkinson’s Disease Society Brain Bank Diagnostic Criteria (Appendix M), without any known cause for Parkinsonism.
- •3. At least 30 years old at the time of PD diagnosis.
- •4. Hoehn and Yahr Staging I-IV in the on” state (Appendix N).
- •5. Mini-Mental State Exam (MMSE, Appendix O) = 26 at Screening.
- •6. Currently being treated with CLE in a dosing regimen which includes an immediate release LD product (e.g., Stalevo® or standard Sinemet® 25 mg-100 mg plus entacapone). Subject must be on a stable regimen of CLE (or benserazide-levodopa-entacapone) for at least 4 weeks at:
- •a total daily levodopa dose of at least 400 mg
- •a minimum CLE dosing frequency of four times per day
- •individual CD-LD or CLE doses that contain an LD dose which is a multiple of 50 mg.
- •7. Able to differentiate on” state from off” state as defined by at least 75% concordance with an experienced rater in on/off” ratings for at least four ratings over the 4-hour training period. The concordance must include at least one on” and one off” rating and must be achieved within two 4-hour training sessions.
- •8. Have predictable off” periods defined by a yes” response to Question #36 on the UPDRS.
- •9. Prior to the Screening Visit, the subject should have an average of at least 2.5 cumulative hours per day of off” time during the waking hours for the last 2 weeks (by history). At Visit 1, the subject must have an average of at least 2.5 hours over 3 days and at least 1 hour each day of off” time based on the 3-day PD diaries recorded on the 3 consecutive days immediately prior to Visit 1.
- •10. At least 10% increase in finger tapping rate (number of taps over a 1-minute period) during the on” state when compared to the off” state at Screening.
- •11. Concomitant therapy with amantadine, anticholinergics, selective monoamine oxidase (MAO) type B inhibitors (e.g., selegiline, rasagiline) or dopamine agonists is allowed as long as the doses and regimens have been stable for at least 4 weeks prior to Screening and the therapy is intended to be constant throughout the course of the study.
- •12. 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, oralcontraception, NuvaRing® or transdermal systems, diaphragm with vaginal spermicide, intrauterine device, condom and partner using vaginal spermicide, surgical sterilization (6 months), progestin implant or injection, postmenopausal female (no menstrual period for > 2 years) or vasectomy (> 6 months).
- •13. Able and willing to comply with the protocol, including availability for all scheduled clinic visits, diary data and blood sample collections, 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. 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 (e.g., progressive supranuclear palsy, corticobasal degeneration, multiple-system atrophy).
- •2. Nonresponsive to LD therapy.
- •3. Combined total score of = 5 on Questions #32, #33, and #34 of the UPDRS or a score of = 3 on Question #33 of the UPDRS.
- •4. Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation), or such procedures are anticipated during study participation.
- •5. Received within 4 weeks of Screening or planning to take during participation in the clinical study: any controlled-release LD product, tolcapone, apomorphine, nonselective MAO inhibitors, or antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder.
- •6. Planning to take during participation in the clinical study: Any CD or LD products not provided by the study, e.g., Lodosyn®, benserazide (Serazide®), Sinemet® CR or any controlled-release LD products, Parcopa® or any fast-dissolving LD-containing products, or any entacapone not provided by the study.
- •7. Allergy or hypersensitivity to CD, LD, entacapone, riboflavin, Yellow Dye #5 (tartrazine), citrus fruit or grape juice.
- •8. Active or history of psychosis.
- •9. Active or history of medical conditions such as peptic ulcers or prior surgery (e.g., bowel procedures) that would interfere with LD absorption.
- •10. Active or history of narrow-angle glaucoma.
- •11. History of malignant melanoma or a suspicious undiagnosed skin lesion which, in the opinion of the Investigator, could be melanoma.
- •12. History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, neuroleptic malignant syndrome or nontraumatic rhabdomyolysis.
- •13. Abnormal kidney function (e.g., serum creatinine level = 1.5 times the upper limit of normal) at Screening or requires dialysis.
- •14. Severe hepatic impairment.
- •15. Received any investigational medications during the 4 weeks prior to Screening.
- •16. Donated blood or plasma within 28 days prior to Visit 1 or planning to donate blood or plasma during the study or within 4 weeks after completing the study.
- •17. Unable to swallow large pills (e.g., large vitamin pills).
- •18. Previously enrolled in IPX066 studies.
- •19. Pregnant or breastfeeding.
- •20. Employees or family members of the Investigator, study site, or sponsor.
- •21. Unable to complete the PD diary.
- •22. In the opinion of the clinical Investigator, the subject should not participate in the study.
研究者
相似试验
进行中（未招募）
1 期
A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson’s DiseaseEUCTR2009-017238-39-DEImpax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)96
进行中（未招募）
1 期
A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s DiseaseIdiopathic Parkinson’s Disease (paralysis agitans)MedDRA version: 12.1Level: LLTClassification code 10061536Term: Parkinson's diseaseEUCTR2009-017238-39-BEImpax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)56
进行中（未招募）
不适用
A Study to Compare IPX066 and Carbidopa / Levodopa / Entacapone (CLE) in Advanced Parkinson’s Disease - NDEUCTR2009-017238-39-ITIMPAX LABORATORIES, INC.56
已完成
3 期
A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066Parkinson's DiseaseNCT01130493Impax Laboratories, LLC110
招募中
不适用
Study of bioequivalence of Levodopa/Carbidopa/Entecapone tablet 200/50/200mg Fanda Pharma (Staparkin 200/50/200mg) and foreign samples on 24 healthy Iranian volunteers.In this study the bioequivalence of test and brand of Staperkin will be evaluated..IRCT20200105046010N9Tabriz University of Medical Sciences24