NCT00247247已完成4 期
Efficacy and Tolerability of Comtess® Versus Cabaseril® as Add-on to Levodopa in the Treatment of Parkinsonian Patients Suffering From Wearing-Off Phenomenon
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Primary objective:
研究概览
简要总结
Multi-centre, randomised, parallel-group study, rater-blinded. Total duration of the study per subject is 12 weeks plus a one- to two-week screening period. There are 6 pre-planned visits per subject: screening visit followed by 5 visits. Approximately 300 patients altogether in up to 25 active German study centres and up to 3 active Lithuanian study centres will be randomised.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients suffering from idiopathic Parkinson's Disease (PD) with wearing-off phenomenon
- •OFF-time per day >= 60 min after the first ON-period in the morning
- •3-5 daily dosages of standard levodopa/DDC inhibitor
- •stable antiparkinsonian treatment 3 weeks prior to the randomisation
排除标准
- •symptomatic parkinsonism
- •concomitant treatment with non-selective MAO inhibitors or a selective MAO-A inhibitor while treated with a MAO-B inhibitor already
- •concomitant treatment with one of the following catechol-structured drugs: rimiterol, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine or apomorphine
- •concomitant treatment with alpha-methyldopa, reserpine, typical or atypical neuroleptics, neuroleptic antiemetics (such as metoclopramide) or other drugs with antidopaminergic action
- •treatment with COMT-inhibitors 4 weeks prior to the randomisation
- •treatment with dopamine agonists 4 weeks prior to the randomisation
- •known hypersensitivity to ergot derivatives and entacapone
- •dementia (MMSE <= 24)
- •depression (Beck Scale >= 17)
结局指标
主要结局
Primary objective:
- Proof of one-sided equivalence in efficacy regarding the OFF-time (total h of awake time) 12 weeks after start of therapy
次要结局
- Secondary objectives:
- - comparison of the tolerability measured as adverse drug reactions in the course of the study
- - comparison of the UPDRS total score 12 weeks after start of therapy assessed by a blinded rater
- - comparison of the Dyskinesia score 12 weeks after start of therapy assessed by a blinded rater
- - comparison of the safety regarding physical examination, vital signs (including blood pressure supine and upright position) and laboratory parameters
- - comparison of the results of the disease specific questionnaire PDQ-39
- - comparison of clinical global evaluation performed by patient
- - comparison of ON-time
- - comparison of proportion of ON-time
- - comparison of daily levodopa doses and total amount of levodopa
- - comparison of daily cabergoline/entacapone doses and total amount of cabergoline/entacapone
研究者
研究点 (2)
Loading locations...
相似试验
已完成
4 期
Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to MethotrexateRheumatoid ArthritisNCT01500278UCB Pharma SA915
已完成
3 期
A Phase 3 Study to Compare the Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and DyslipidemiaDyslipidemiasHypertensionNCT04074551Hanmi Pharmaceutical Company Limited145
已完成
不适用
A pragmatic randomised controlled trial of the cost-effectiveness of palliative therapies for patients with oesophageal cancerCancer (neoplasms): OesophagusOesophagusCancerISRCTN18914993Department of Health (UK)217
终止
3 期
Carisbamate Retention Study (CaReS): Comparative Study on the Long Term Effectiveness, Safety and Tolerability of Carisbamate Compared to Two Other Frequently Prescribed Anti-epileptic Drugs (AEDs) in Patients With Epilepsy.SeizuresEpilepsyNCT00563459SK Life Science, Inc.89
已完成
3 期
Efficacy and Tolerability of Human FSH Versus Recombinant FSH (Follitropin Alpha) in ICSI.InfertilityNCT00335725IBSA Institut Biochimique SA151