EUCTR2006-001793-24-AT进行中（未招募）不适用
A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available
BIAL - Portela & Cª, SA0 个研究点目标入组 250 人开始时间: 2006年7月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
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
- •Criteria for Inclusion:
- •At visit 1 (screening), patients must be/have:
- •ability to comprehend and willingness to sign an informed consent form; aged 30 to 80 years, inclusive; diagnosis of idiopathic Parkinson’s disease according to the UK Parkinson’s Disease Society Brain Bank Clinical Diagnosis Criteria (UKPDSBBCDC); disease severity less than Stage 5 (modified Hoehn &Yahr staging) while during the off” time; treated with levodopa plus DDCI for at least one year with clear clinical improvement; treated with four to eight (inclusive) daily doses of standard levodopa plus DDCI (bedtime dose of a slow-release formulation is permitted); stable regimen of levodopa plus DDCI and other anti-PD drugs for at least four weeks before screening; signs of end-of-dose wearing-off” phenomenon (end-of-dose deterioration) with average total daily off time while awake of at least 1.5h excluding the early morning pre-first dose off” despite optimal anti-PD therapy, determined subjectively and objectively (observations of the investigator) for a minimum of two months before screening; ability to keep reliable diaries of motor fluctuations (alone or with family/caregiver assistance); patient must be amenorrhoeic for at least one year or surgically sterile for at least six months before screening, in case of women of childbearing potential, patient must be using a double-barrier contraceptive method.
- •At visit 2 (entry to Period 1), patients must be/have:
- •results of laboratory tests acceptable by the investigator (not clinically significant for the well-being of the patient or for the purpose of the study); At visit 3 (randomisation), patients must be/have: at least 80% treatment medication (levodopa/DDCI + investigational product) compliance with the recommended dosage regimen of single-blind placebo during Period 1; self-rating diary charts filled-in in accordance with the diary chart instructions (less than three errors per day are allowed); average of at least 1.5 off” hours per day (excluding the early morning pre-first dose off” period) on the three-day diaries, filled in at the three days preceding visit V3, according to the self-rating diary charts completed during Period 1.
- •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
- •Criteria for Exclusion:
- •At visit 1 (screening), patients must not be/have:
- •non-idiopathic PD (atypical parkinsonism, symptomatic parkinsonism, Parkinson-plus syndrome); dyskinesia disability score more than 3 in UPDRS IV.A item 33; DSM IV criterion for dementia; major depressive episode within the six months before screening; treatment with entacapone, tolcapone, neuroleptics, antidepressants [except serotonin specific reuptake inhibitors (SSRI) or imipraminics (desipramine, imipramine, clomipramine and amitriptyline)], monoamine oxidase inhibitors (except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation or rasagiline up to 1 mg/day), or antiemetics (except domperidone) within the three months before screening; treatment with apomorphine within the previous month before screening; dosage change of concomitant anti-PD medication within 4 weeks of screening; any investigational product within the three months (or within five half-lives, whichever is longer) before screening; a psychiatric or any medical condition that might place the subject at increased risk or interfere with assessment; a clinically relevant ECG abnormality; a history or current evidence of heart disease, including but not limited to myocardial infarction, angina, congestive heart failure and cardiac arrhythmia; pheochromocytoma; known hypersensitivity to the ingredients of products used; unstable concomitant disease being treated with changing doses of medication; history or current evidence of any relevant disease in the context of this study, i.e., with respect to the safety of the subject or related to the study conditions, e.g., which may influence the absorption or metabolism (e.g., hepatic impairment) of the investigational drug; any abnormality in the liver enzymes above two times the upper limit of the normal range.
研究者
相似试验
进行中（未招募）
不适用
A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not availableEUCTR2006-001793-24-PTBIAL - Portela & Cª, SA250
招募中
不适用
A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF LIGELIZUMAB (QGE031) IN THE TREATMENT OF CHRONICSPONTANEOUS URTICARIA (CSU) IN ADOLESCENTS AND ADULTS INADEQUATELY CONTROLLED WITH H1-ANTIHISTAMINES-L508 Other urticariaOther urticariaL508PER-035-18OVARTIS BIOSCIENSES PERU S.A.,16
进行中（未招募）
1 期
A Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients 1 to <12 Years of Age with Influenza-Like SymptomsMedDRA version: 20.0 Level: LLT Classification code 10022001 Term: Influenza (epidemic) System Organ Class: 100000004862MedDRA version: 20.1 Level: LLT Classification code 10022003 Term: Influenza B virus infection System Organ Class: 100000004862MedDRA version: 20.1 Level: LLT Classification code 10022002 Term: Influenza A virus infection System Organ Class: 100000004862MedDRA version: 20.0 Level: LLT Classification code 10016790 Term: Flu System Organ Class: 100000004862InfluenzaEUCTR2018-002169-21-ESRoche Farma SA que realiza un el ensayo en España y que actúa como representante de F. Hoffmann-La Roche Ltd173
进行中（未招募）
1 期
A Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients 1 to <12 Years of Age with Influenza-Like SymptomsInfluenzaEUCTR2018-002169-21-PLF. Hoffmann-La Roche Ltd173
招募中
不适用
PARADISE-MI: PROSPECTIVE ARNI VERSUS ACE INHIBITOR TRIAL TO DETERMINE SUPERIORITY IN REDUCING HEART FAILURE EVENTS AFTER MYOCARDIAL INFARCTIO-I50I50PER-047-16OVARTIS BIOSCIENSES PERU S.A.,28