EUCTR2009-014688-37-FR进行中（未招募）1 期
A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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 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 (Appendix D), 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 C).
- •5.Mini-Mental State Exam (MMSE, Appendix F) = 26 at Screening.
- •6.Currently being treated with IR LD (CD-LD or benserazide-LD) and on a stable regimen of IR LD for at least 4 weeks and:
- •Requiring a total daily IR LD dose of at least 400 mg
- •Having a minimum dosing frequency of four times per day.
- •7.Able to differentiate on” state from off” state as defined by at least 75% concordance with a trained 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 (Appendix E).
- •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.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.
- •11.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).
- •12.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.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.Subjects who score a combined total 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 if such procedures are anticipated during study participation.
- •5.Received within 4 weeks of Screening Visit or planning to take during participation in the clinical study: any controlled-release LD product, additional CD (e.g., Lodosyn®) or benserazide (e.g. Serazide®), catechol-O-methyl transferase inhibitors (e.g., entacapone and tolcapone), nonselective MAO inhibitors, apomorphine, and antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder.
- •6.Allergic to the excipients of IPX066 (Appendix O).
- •7.Allergic to Yellow Dye #5 (tartrazine).
- •8.History of or currently active psychosis.
- •9.Active or prior medical conditions such as peptic ulcers or prior surgical (e.g., bowel) procedures that would interfere with LD absorption.
- •10.Active or history of narrow-angle glaucoma.
- •11.Subjects with a 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, or neuroleptic malignant syndrome and/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.Unable to swallow large pills (e.g., large vitamin pills).
- •17.Subjects who have been previously enrolled in IPX066 studies.
- •18.Subjects who, in the opinion of the clinical investigator, should not participate in the study.
- •19.Pregnant or breastfeeding.
- •20.Employees or family members of the investigator, study site or the sponsor.
- •21.Subjects who are unable to complete the diary.
- •22.Positive screen on the m-MIDI as defined in Appendix M.
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