A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson’s Disease

Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)0 个研究点目标入组 96 人开始时间: 2010年7月28日最近更新: 2022年1月4日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 96

研究概览入排标准研究者记录与标识符相似试验

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. For subjects participating in Cohort 1 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.
•Each subject must meet the following inclusion criteria in order to be enrolled in Part 2 of the study:
•1. Successful completion of Part 1 of IPX066-B09-06 as of June 30, 2011.
•2. In the opinion of the Investigator, the Parkinson's disease diagnosis is still valid and the subject remains eligible for LD therapy.
•Are the trial subjects under 18? no
•Number of subjects for this age

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 peptic ulcer or surgical procedure of the stomach, the small intestine or the large intestine.
•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.
•Each subject must be free of the following exclusion criteria in order to be enrolled in the study:
•1. Received any investigational medications other than IPX066 after enrollment in Part 1 of this study.
•2. Anticipates functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) during study participation.
•3. Received within 4 weeks prior to Baseline Visit or planning to take the following medications during study participation: nonselective monoamine oxidase (MAO) inhibitors (with the exception of rasagiline).
•4. In the opinion of the Investigator, should not participate in the study.

研究者

发起方

Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)

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