A PHASE 3, DOUBLE-BLIND, PLACEBO-AND ACTIVE-CONTROLLED DOSE RANGE-FINDING EFFICACY AND SAFETY STUDY OF PRELADENANT IN SUBJECTS WITH EARLY PARKINSON´S DISEASE (PHASE 3 PROTOCOL N°. P05664)

SCHERING PLOUGH RESEARCH INSTITUTE,0 个研究点目标入组 0 人开始时间: 2010年11月18日最近更新: 2023年9月4日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方: SCHERING PLOUGH RESEARCH INSTITUTE,

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

入排标准

年龄范围: 30 至 85（—）

入选标准

•Has a diagnosis of idiopathic PD for < 5 years.
•If receiving amantadine and/or anticholinergics, must have been on a stable regimen of treatment for at least the 5 weeks immediately before Screening. (Note: Participants who are not taking any medications for PD are permitted to enroll in this trial.)
•Must have a UPDRS Part 3 score of =10, a Hoehn and Yahr Stage =3, be =30 to =85 years of age, and have results of Screening clinical laboratory tests drawn within 5 weeks prior to randomization, clinically acceptable to the investigator, and not within the parameters specified for exclusion.
•If sexually active or plan to be sexually active, must agree to use a highly effective method of birth control while the participant is in the study and for 2 weeks after the last dose of study drug. A male participant must also not donate sperm during the trial and within 2 weeks after the last dose of study drug.

排除标准

•Must not have a form of drug-induced or atypical Parkinsonism, cognitive impairment (ie, Montreal Cognitive Assessment [MoCA] score <22), bipolar disorder, untreated major depressive disorder, schizophrenia, or other psychotic disorder; history of exposure to a known neurotoxin, or any neurological features not consistent with the diagnosis of PD as assessed by the investigator.
•Must not have had surgery for PD.
•Must not have a history of repeated strokes with stepwise progression of Parkinsonism or head injuries, or a stroke within 6 months of screening; poorly controlled diabetes; abnormal renal function; or a severe or ongoing unstable medical condition.
•Must not have failed to show a therapeutic response if a diagnostic levodopa (L dopa) challenge had been done with a large test dose (>500 mg) of L dopa (if malabsorption excluded), or failed to respond to an adequate previous treatment with dopaminergic therapy.
•Must not have been treated with L dopa or dopamine agonists for 30 days or more. A participant who has been treated with L-dopa or dopamine agonists for <30 days will be allowed to enter the study. These participants must stop taking dopaminergic medication 30 days prior to Randomization.
•Must not be at imminent risk of self-harm or harm to others.
•Must not have elevated blood pressure (BP) (systolic BP =150 mm Hg or diastolic BP =95 mm Hg) that cannot be adequately controlled with antihypertensive medication, as demonstrated by 2 BP measurements meeting acceptable BP criterion at consecutive scheduled or unscheduled visits between Screening and Randomization (a 5-6 week period), one of which must be the Randomization visit.
•Must not have had any clinically significant cardiovascular event or procedure for 6 months prior to Randomization, including, but not limited to, myocardial infarction, angioplasty, unstable angina, or heart failure; and a participant must not have heart failure staged New York Heart Association Class III or IV.
•Must not have an alanine aminotransferase (ALT) or aspartate amino transferase (AST) = 3 x the upper limit of normal (ULN) or total bilirubin (T BIL) = 1.5 x ULN.
•Must not have active serologically-confirmed hepatic dysfunction (defined as viral infection [Hepatitis B, C, or E; Epstein-Barr virus (EBV)]; cytomegalovirus [CMV] or a history of diagnosis of drug- or alcohol-induced hepatic toxicity or frank hepatitis, or a history of diagnosis of drug- or alcohol-induced hepatic toxicity or frank hepatitis.)
•Must not have a history within the past 5 years of a primary or recurrent malignant disease 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.
•Must not have received certain prespecified medications or ingested high tyramine-containing aged cheeses (eg, Stilton) for a prespecified time window before the trial, during the trial, and for 2 weeks after the trial.
•Must not have an average daily consumption of more than three 4 ounce glasses (118 mL) of wine or the equivalent.
•Must not have a severe or ongoing unstable medical condition (eg, any form of clinically significant cardiac disease, symptomatic orthostatic hypotension, seizures, or alcohol/drug dependence.)
•Must not have allergy/sensitivity to investigational product(s) or its/their excipients.

研究者

发起方

SCHERING PLOUGH RESEARCH INSTITUTE,

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