EUCTR2013-002254-70-IT进行中（未招募）1 期
A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 613
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
- •Each subject who meet all of the following inclusion criteris to qualify for entrance into the study:
- •1) Male or female >/= 30 years of age at enrollment;
- •2) Subjects diagnosed with idiopathic PD based on the UK Parkinson's Disease Society (UKPDS) Brain Bank Diagnostic Criteria;
- •3) Subjects with a minimum Modified Hoehn and Yahr Scale stage classification of 2, but no more than 4 when in the ON state;
- •4) Subjects who have been treated with levodopa therapy for at least 1 year and who continue to have a beneficial clinical response at Baseline visit;
- •5) Subjects who are currently taking levodopa combinations (carbidopa/levodopa or benserazide/levodopa) with a total daily levodopa dosage of at least 400 mg plus a recommended, clinically effective dose of at least one adjunctive medication approved to treat Parkinson's disease such as a dopamine agonist, MAO-B inhibitor, or COMT inhibitor taken at the recommended dosages listed in the country-approved label for at least 2 weeks prior to randomization. (Note that subjects treated with anticholinergic medications or amantadine alone are not considered adequately treated with adjunctive antiparkinsonian medications and cannot be enrolled);
- •6) Subjects treated with stable dopaminergic regimen for at least 4 weeks immediately prior to randomization;
- •7) Subjects who have documented end-of-dose wearing-off and levodopa -induced dyskinesia;
- •8) Subjects who have successfully completed diary training and a practice diary prior to Week-1 and be confirmed as having passed the training at Week-1;
- •9) Subjects and site staff who have completed diary concordance testing and have achieved concordance of 80% with respect to both ON and OFF periods at the Week-1 visit;
- •10) Subjects who have successfully completed 3 valid ON/OFF patient diaries on the 3 consecutive days immediately prior to the Baseline visit;
- •11) Subjects who are experiencing significant motor fluctuations while receiving levodopa plus adjuvant medication(s) as defined by an average of at least 2 hours OFF time on the three 24-hour ON/OFF patient diaries prior to the Baseline visit;
- •12) Women of child-bearing potential (WOCBP) must use a reliable method of contraception (e.g., oral contraceptive or long-term injectable or implantable hormonal contraceptive, double barrier methods [such as condom plus diaphragm, condom plus spermicide foam, condom plus sponge], or intra-uterine devices), and must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline
- •a)WOCBP includes any female who has experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea >/= 24 consecutive months or a serum follicle-stimulating hormone [FSH] > 30 IU/L in the absence of hormone replacement therapy [HRT];
- •13) Subjects who have given written informed consent.
- •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 335
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 274
排除标准
- •A subject who meets any of the following exclusion criteria will NOT qualify for the study:
- •1) Subjects currently treated with apomorphine and/or dopamine receptor antagonists or direct gastroinestinal levodopa infusion;
- •2) Subjects treated with anticholinergic medications or amantadine alone (not considered adequately treated with adjunctive antiparkinsonian medications);
- •3) Subjects who have been treated within 30 days before Baseline (or 5 half-lives of the compound, if longer) with any investigational agents;
- •4) Subjects who have a history of psychotic illness;
- •5) Subjects who are experiencing sleep attacks that would interfere with the integrity of the trial or pose a risk to the subjects in participating in the trial;
- •6) Subjects who have undergone a neurosurgical operation for PD (e.g., pallidotomy, thalamotomy, or deep brain stimulation);
- •7) Subjects who have been previously treated with istradefylline;
- •8) Subjects who are currently receiving another A2a antagonist;
- •9) Subjects who are taking potent CYP34A inhibitors (systematic antifungals such as ketoconazole);
- •10) Subjects who are taking potent CYP34A inducers (such as St John's Wort and rifampin);
- •11) Subjects who have atypical parkinsonism;
- •12) Subjects who have secondary parkinsonism variants;
- •13) Subjects who have had a diagnosis of cancer or evidence of continued malignancy within 3 years of study enrollment (with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ prostate cancer with a normal prostate-specific antigen [PSA] post resection);
- •14) Subjects, who, for any reason, are judged by the Investigator to be inappropriate for this study, including a subject who is unable to communicate or to cooperate with the Investigator or who has/had a clinically significant illness or abnormal physical examination that may compromise the safety of the subject during the trial or affect the ability of the subject to adhere to study procedures;
- •15) Subjects who have clinical laboratory test results that are clinically unaccepatable by the Investigator, or who have an alanine aminotransferase (ALT) and/or an aspartate aminotranserfase (AST) level > 3 times the upper limit of normal (ULN), and serum total bilirubin >2 times the ULN at Screening;
- •16) Subjects judged to have mild, moderate, or severe hepatic impairment based upon Child-Pugh categorization A, B, or C;
- •17) Subjects with a MoCA score of 18) Subjects with a BDI score of > 20;
- •19) Subjects with suicidal behavior within the previous month;
- •20) Subjects who smoke > 5 cigarettes per day;
- •21) Subjects who have a history of drug abuse or dependence within the last year by the Diagnostic and Statistical Manual of Mental disorders, Revised (DMS-IVR);
- •22) Subjects must have not known or suspected sensitivity to the investigational study drug or its excipients;
- •23) Subjects who have untreated major depressive disorder;
- •24) Subjects who have a history of seizures or seizure disorders;
- •25) Subjects who have a history of neuroleptic malignant syndrome;
- •26) Subjects who are pregnant (confirmed by beta human chorionic gonadotrophin [B-HCG]) or breastfeeding.
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