主要研究目的研究空腹和餐后状态下单次口服卡左双多巴缓释片（卡比多巴50mg，左旋多巴200mg，江苏和晨药业有限公司提供）与参比制剂（卡比多巴50mg，左旋多巴200mg，息宁®；持证商：MSD Sharp & Dohme GmbH）后卡比多巴、左旋多巴在中国健康受试者体内的药代动力学（PK）特征，评价空腹和餐后状态下口服两种制剂的生物等效性。次要研究目的评价中国健康受试者空腹和餐后状态下，单次口服受试制剂卡左双多巴缓释片和参比制剂卡左双多巴缓释片后的安全性。

开始日期2024-04-13

申办/合作机构

江苏和晨药业有限公司

NCT06219915 / Recruiting临床1/2期IIT

Neurobiological Drivers of Mobility Resilience: The Dopaminergic System

Walking with age becomes both slower and less 'automated', requiring more attention and brain resources. As a result, older adults have a greater risk of negative outcomes and falls. There is an urgent need to identify factors that can help compensate for these harmful factors and reduce walking impairments, as there are currently no effective treatments available. Investigators have recently discovered that
20% of older adults maintain fast walking speed even in the presence of small blood vessel brain changes and leg problems, thus appearing to be protected against these harmful factors. The investigators work suggests that the brain dopamine (DA) system may be a source of this protective capacity. Investigators have also shown that lower levels of dopamine are associated with slow walking. Investigators will be investigating the role of dopamine on slow walking and other parkinsonian signs in this double-blinded, placebo-controlled study using detailed clinical assessment, assessment of dopamine activity, and clinical interventions.

开始日期2024-03-15

申办/合作机构

University of Michigan

[+1]

NCT06003608 / RecruitingN/A

Observational, Cross-sectional Clinical Study in Parkinson's Disease (PD) Patients and Healthy Controls (HC) to Identify PD Specific Microbial and Metabolic Fingerprints in Small Intestinal (SI) Fluid and Blood

Observational cross-sectional study in PD patients and healthy controls (HC) using an investigational medical device consisting of a passive small intestine microbiome aspiration (SIMBA) system (capsule) that is ingested orally and recovered together with the stools (home recovery) together with blood sampling (during the onsite visit).

开始日期2024-02-19

申办/合作机构

Nimble Science Ltd.初创企业

[+1]

100 项与卡比多巴/左旋多巴相关的临床结果

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100 项与卡比多巴/左旋多巴相关的转化医学

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100 项与卡比多巴/左旋多巴相关的专利（医药）

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742

项与卡比多巴/左旋多巴相关的文献（医药）

2024-05-01·The Lancet Neurology

Safety and efficacy of continuous subcutaneous levodopa–carbidopa infusion (ND0612) for Parkinson's disease with motor fluctuations (BouNDless): a phase 3, randomised, double-blind, double-dummy, multicentre trial

Article

作者: Arkadir, David ; Pacchetti, Claudio ; Hernandez-Vara, Jorge ; Sasson, Nissim ; Durif, Franck ; Boyd, James ; Grandas Perez, Francisco ; Rudzinska, Monika ; Revuelta, Gonzalo ; Flitman, Stephen ; Spalletta, Gianfranco ; Case, Ryan ; Martinez Torres, Irene ; Dhall, Rohit ; Buyan Dent, Laura ; Tessitore, Alessandro ; Corbillé, Anne-Gaëlle ; Martinez Castrillo, Juan Carlos ; Sarwar, Nighat ; Lopez Lozano, Juan ; Chaudhuri, Kallol Ray ; Pavese, Nicola ; Rascol, Olivier ; Slobodin, Tatyana ; Rodrigues, Ana Margarida ; Dethy, Sophie ; Lopez-Manzanares, Lydia ; Valkovic, Peter ; Albanese, Alberto ; Ellenbogen, Aaron ; Adar, Liat ; Afshari, Mitra ; Poewe, Werner ; Ostrem, Jill ; Olanow, C Warren ; Giladi, Nir ; Kieburtz, Karl ; Isaacson, Stuart H ; Marconi, Roberto ; Koziorowski, Dariusz ; Marques, Ana-Raquel ; Isa, Arnaldo ; Verhagen, Leo ; Juncos, Jorge L ; Moskovko, Sergii ; Salin, Laurence ; Balaguer Martinez, Ernest ; Zalyalova, Zuleykha ; Mentreddi, Aashoo ; Sarva, Harini ; Stocchi, Fabrizio ; Klodowska-Duda, Gabriela ; Pellicano, Clelia ; Yardeni, Tami ; Tai, Yen ; Goudreau, John ; Bogucki, Andrzej ; Ferreira, Joaquim J ; Zhukova, Irina ; Kanchana, Sulada ; Freire Alvarez, Eric ; Zarubova, Katerina ; Tagliati, Michele ; Neryanova, Yuliya ; Rodriguez, Ramon ; Hassin-Baer, Sharon ; Amelin, Alexander ; Cooney, Jeffrey ; Lopes, Nelson ; De Pandis, Maria Francesca ; Lytvynenko, Nataliya ; Mir Rivera, Pablo ; Carroll, Camille ; Espay, Alberto J ; Schwartzbard, Julie ; Danaila, Teodor ; Djaldetti, Ruth ; Gurevich, Tanya ; Kulisevsky Bojarski, Jaime ; Scorr, Laura ; LeWitt, Peter A ; Yahalom, Gilad ; Pahwa, Rajesh ; Slevin, John ; Badarny, Samih ; Vostrikova, Elena ; Luo, Lan ; Onofrj, Marco

BACKGROUNDConventional oral levodopa therapy for the treatment of Parkinson's disease can be associated with variations in plasma concentrations. Levodopa infusion strategies might provide more consistent drug delivery and fewer motor fluctuations. We aimed to assess the safety and efficacy of a continuous 24 h/day subcutaneous infusion of ND0612 (a levodopa-carbidopa solution) compared with oral immediate-release levodopa-carbidopa for the treatment of motor fluctuations in people with Parkinson's disease.METHODSWe conducted a phase 3, randomised, double-blind, double-dummy, active-controlled, multicentre trial at 117 academic and community neurology sites in 16 countries, including in Europe, Israel, and the USA. Eligible participants were men and women aged 30 years or older with a diagnosis of Parkinson's disease (Hoehn and Yahr stage ≤3 in the on state) who experienced at least 2·5 h/day of off time. Participants underwent an open-label run-in phase (<12 weeks), during which time optimal regimens were established for both oral immediate-release levodopa-carbidopa and for 24 h/day subcutaneous ND0612 infusion (levodopa-carbidopa 60·0/7·5 mg/mL), with supplemental oral levodopa-carbidopa if needed. Participants were then randomly assigned (1:1) to 12 weeks of double-blind treatment with their optimised regimen of either subcutaneous ND0612 or oral levodopa-carbidopa, with matching oral or subcutaneous placebo given as required to maintain blinding. Randomisation was done via an interactive web response system, stratified by region, using a permuted block schedule. Participants, study partners, treating investigators, study site personnel, and the sponsor were masked to treatment group allocation. The primary efficacy endpoint was the change from baseline (ie, time of randomisation, when all patients were receiving an optimised open-label ND0612 regimen) to end of the double-blind phase in total daily on time without troublesome dyskinesia, analysed by intention to treat. This trial is registered with ClinicalTrials.gov, NCT04006210, and is complete.FINDINGSBetween Sept 30, 2019, and April 8, 2022, 381 participants were enrolled, of whom 259 (68%) were randomly assigned, 128 (49%) to subcutaneous ND0612 and 131 (51%) to oral levodopa-carbidopa. 243 (94%) participants completed the study. Treatment with subcutaneous ND0612 provided an additional 1·72 h (95% CI 1·08 to 2·36) of on time without troublesome dyskinesia compared with oral levodopa-carbidopa (change from baseline of -0·48 h [-0·94 to -0·02] with subcutaneous ND0612 vs -2·20 h [-2·65 to -1·74] with oral levodopa-carbidopa; p<0·0001). Significant treatment differences favouring subcutaneous ND0612 were also found in the first four of nine prespecified hierarchical outcomes of daily off time (-1·40 h [95% CI -1·99 to -0·80]), Movement Disorders Society-Unified Parkinson's Disease Rating Scale part II scores (-3·05 [-4·28 to -1·81]), Patients Global Impression of Change (odds ratio [OR] 5·31 [2·67 to 10·58]), and Clinical Global Impression of Improvement (OR 7·23 [3·57 to 14·64]). Hierarchical testing ended after the fourth secondary endpoint. Adverse events were reported by 287 (89%) of 322 participants during open-label ND0612 optimisation, and by 103 (80%) of 128 in the ND0612 group and 97 (74%) of 131 in the oral levodopa-carbidopa group during the double-blind phase. The most common adverse events were infusion-site reactions (266 [83%] participants during open-label ND0612, and 73 [57%] in the ND0612 group vs 56 [43%] in the oral levodopa-carbidopa group during the double-blind phase), most of which were mild. Serious adverse events in four participants in the ND0612 group were related to study treatment (infusion-site cellulitis [n=2], infusion-site abscess and infusion-site ulcer [n=1]; and paraesthesia and peripheral sensorimotor neuropathy [n=1]). One participant in the ND0612 group died during the double-blind phase, but the death was not related to study treatment (fall leading to traumatic brain injury).INTERPRETATIONResults of this phase 3 study showed that subcutaneous ND0612 used in combination with oral immediate-release levodopa-carbidopa increased on time without troublesome dyskinesia and reduced off time, with a favourable benefit-risk profile. ND0612 might offer a safe and efficacious subcutaneous levodopa infusion approach to managing motor fluctuations in people with Parkinson's disease. The ongoing open-label extension phase will provide further information on the long-term efficacy and safety of treatment.FUNDINGNeuroDerm.

2024-04-08·Parkinson's Disease

Home-Based Titration with Duodenal Infusion of Levodopa-Carbidopa Intestinal Gel in People with Parkinson’s Disease: An Observational Feasibility Study

Article

作者: Nielsen, Nick Schou ; Isenberg, Asher Lou ; Møller, Michael Hougaard ; Olsen, Marc Klee ; Javidi, Mahsa ; Thomsen, Trine Hørmann ; Biering-Sørensen, Bo ; Schack Frederiksen, Inge Mona ; Vilhelmsen, Jeanet ; Olsen, Louise ; Clausen, Jesper Bøje

Background. Testing and titration of the right levodopa equivalent dose are usually performed during a hospital admission. However, optimal dose titration in people with Parkinson’s disease (PwPs) may depend on home environment, emotional stress, and physical activity of everyday life. Objective. Firstly, to evaluate the feasibility and safety of a home-based LCIG titration program and patients’/caregivers’ satisfaction. Secondly, to identify barriers and facilitators for home-based titration. Method. This study assesses the feasibility and safety of home-based titration of levodopa duodenal infusions with the use of self-reported evaluation questionnaires with open-ended questions included, registration of total time used, and number of contacts/visits. A telemedicine solution was used to remotely monitor the patients, adjust treatment, and provide support and guidance to patients and caregivers. Results. Ten of 12 PwPs (5 females and 7 males) completed the total titration program. Eight of the 12 PwPs were dependent on help. These 8 PwPs also had a high burden of nonmotor symptoms (NMS). Cognitive impairments varied in severity (range 16–30). Time spent with home visits was on average 93.4 minutes (ranging from 35 to 180 minutes), and the length of the total titration (LCIG initiation to termination of titration) was on average 3.4 days with 2–5 (mean 3.2) contacts/visits with PD team members. The average score on the satisfaction evaluation questionnaires was lower in the caregiver group (mean 31.8) than the PwP outcome (mean 36.2). Conclusions. Telehealth-assisted home-based titration programs are feasible due to the length of the titration period, number of contacts, and time spent in PwPs’ private homes, are rated satisfactory and safe by PwPs and caregivers, and may be a substitute for in-hospital treatment. Clinical recommendations including facilitators and barriers from a patient/caregiver perspective are displayed. This trial is registered with NCT4196647.

2024-04-01·Neurology and Therapy

Dyskinesia and Pain in Advanced Parkinson’s Disease: Post Hoc Analysis from the Phase 3b, Open-Label, Randomized DYSCOVER Study

Article

作者: Bergmann, Lars ; Kovács, Norbert ; Sánchez-Soliño, Olga ; Spanaki, Cleanthe ; Vanni, Paola ; Lopez-Manzanares, Lydia ; Freire-Alvarez, Eric ; Kurča, Egon ; Gao, Tianming

INTRODUCTIONThe DYSCOVER study was a phase 3b, open-label, randomized trial (NCT02799381) that evaluated levodopa-carbidopa intestinal gel (LCIG) versus optimized medical treatment (OMT) in patients with Parkinson's disease (PD) and a high burden of dyskinesia at baseline (defined as Unified Dyskinesia Rating Scale [UDysRS] total score ≥ 30). At week 12, patients receiving LCIG versus OMT experienced significant improvements in dyskinesia, pain, and health-related outcomes. The objective of this analysis was to examine correlations between dyskinesia, pain, and health-related outcomes in PD.METHODSThis post hoc analysis assessed correlations between UDysRS, King's Parkinson's Disease Pain Scale (KPPS), 8-item Parkinson's Disease Questionnaire (PDQ-8), Unified Parkinson's Disease Rating Scale part II, Clinical Global Impression of Severity (CGI-S) or Change (CGI-C), and "On" time without troublesome dyskinesia at baseline and after 12 weeks of LCIG or OMT. Correlations were assessed by Pearson correlation coefficients (categorization: weak, r = 0.20-0.39; moderate, r = 0.40-0.59; strong, r ≥ 0.60).RESULTSAmong 61 patients, moderate-to-strong positive and significant correlations were observed between UDysRS and KPPS scores (baseline, r = 0.47; week 12 change from baseline [CFB], r = 0.63; all p < 0.001). UDysRS and KPPS scores had moderate-to-strong positive and highly significant correlations with PDQ-8 scores (baseline, r = 0.45 and 0.46, respectively; CFB, r = 0.54 and 0.64, respectively; all p < 0.001). Moderate positive and significant correlations were observed between UDysRS and CGI-S/CGI-C scores (baseline, r = 0.41; CFB, r = 0.47; all p < 0.001).CONCLUSIONSIn patients with high dyskinesia burden, positive correlations were observed between dyskinesia, pain, and health-related quality of life (HRQoL) at baseline. Improvements in dyskinesia and pain were associated with improvements in HRQoL, demonstrating the clinical burden of troublesome dyskinesia.TRIAL REGISTRATION NUMBERClinicaltrials.gov identifier NCT02799381.

155

项与卡比多巴/左旋多巴相关的新闻（医药）

2024-04-30

·米内网

【市场】8亿神经系统药，重庆华邦制药入局

精彩内容日前，CDE官网显示，重庆华邦制药的多巴丝肼片以仿制4类报产在审。米内网数据显示，多巴丝肼片在2022年中国公立医疗机构终端销售规模超过8亿元，2023年上半年同比增长3.13%，是抗帕金森氏病化药TOP1产品。多巴丝肼片主要用于治疗帕金森病、症状性帕金森综合征（脑炎后、动脉硬化性或中毒性），但不包括药物引起的帕金森综合征。2023年上半年中国公立医疗机构终端抗帕金森氏病化药产品TOP10来源：米内网中国公立医疗机构药品终端竞争格局多巴丝肼片在近年中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端销售规模稳步攀升，2022年超过8亿元，2023年上半年同比增长3.13%，是抗帕金森氏病化药TOP1产品。多巴丝肼片批文情况来源：米内网中国上市药品（MID）数据库米内网数据显示，多巴丝肼片有3家企业拥有生产批文，花园生物和华海药业过评，重庆华邦制药、武汉人福药业、重庆药友制药等11家企业以仿制4类报产在审，获批后视同过评。今年以来，重庆华邦制药已有地奈德乳膏获批上市；5款产品报产在审，而多巴丝肼片则是公司在抗帕金森氏病化药领域报产的第2款产品，在此之前，公司已有卡左双多巴缓释片报产在审。资料来源：米内网数据库、公司公告注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

上市批准一致性评价

2024-04-28

·梅斯医学

曝渐冻症进口药在上海多家医院缺货

近日，上海不少渐冻症患者家属反映，他们所依赖的进口药物利鲁唑片，又叫"力如太"，在市区的多家医院出现了缺货现象，患者和家属都忧心如焚。渐冻症是一种不可逆的致死性运动神经元病，主要症状为四肢和躯干肌肉表现进行性加重的肌肉无力和萎缩，逐渐失去运动功能，就像被“冻住”一般。该病一般进展迅速，半数以上患者确诊后平均生存时间为3-5年，最后多死于呼吸肌无力导致的呼吸衰竭。据估计，ALS在全球范围内的发病率约为十万分之二。渐冻症与阿尔茨海默症一样，至今发病机制尚不明确，这也导致ALS新药的研发失败率高，治疗药物十分有限。目前我国获批用于治疗ALS的药物只有利鲁唑和依达拉奉。利鲁唑是一种苯并噻唑衍生物，可阻断中枢神经系统中的谷氨酸能神经传递。据了解，利鲁唑片市场价格，3689元一盒，每盒包含56片，一般可供患者服用28天。目前，由于这款药物已经纳入医保，患者每月仅需自付千元左右。由于渐冻症患者总数较少，不少市区医院都没有进货这款药物，原来市中心也只有华山、中山等医院有所备货。但从今年2月份以来，市区的这几家医院也都配不到这款药品，患者家属陷入了困境。一位渐冻症患者家属在接受采访时说：“我问过的，说现在这个药没有，华山、六院我都问过，六院也是三甲医院都没有，中山也没有。他们理由就是现在这个药没有，要么吃国产。”尽管控制渐冻症的药物中也有国产仿制药，但多数患者和家属出于对药物效果的考虑和对原用药品的信任，仍然坚持选择“力如太”。记者从患者处了解到，进口药和国产仿制药的一大区别在于，进口药入喉咙即化，而国产药融化的速度并没有那么快，这看似很细微的差别，对于吞咽功能逐渐丧失的渐冻症患者来说，却至关重要。类似的情况也发生在了嘉定的过先生身上，他的老伴2021年10月被确诊为渐冻症，依赖“力如太”控制病情。医院药房告诉过先生，因为批号不对，药房进不了。由于渐冻症患者行动不便，上海有一批志愿者专门为他们无偿服务，帮他们配药，而医院药房的说法，一些志愿者在代配药时也有所耳闻。志愿者许先生回忆，这款药物未进医保时单盒价格为4300多元，进医保后单盒价格从3800多元一路跌至3600元左右，患者承担的个人自付部分根据不同情况盒在900多元至1300多元不等。记者走访，探寻断货原因记者后续又致电了12393，医疗保障服务热线，该服务热线工作人员查询后透露，今年三、四月份，中山和华山医院曾进货过”力如太“这款药物，但是量非常小。倒是一家位于松江的养志康复医院，一直持续进货至今，进货量也比较稳定。记者走访同济大学附属养志康复医院了解到，他们是在阳光医药采购平台进货，且从未间断。记者又走访了售有“力如太”的两家药店，两家药店的工作人员透露，目前在这两家药店也可以买到“力如太”，但库存不多。其中一家药店，国药关爱大药房工作人员告诉记者，目前“力如太”是可以走医保的，但是要提前预定，药房这边订货。“因为这个药现在用得少，销量少，备的货也少。我们也找了很久才找到这个供货商才进到的，而且也属于提前打过招呼给他备的货，后期要用的话，提前一周跟我联系，我这边帮你进。”多种进口药都曾出现过断货或供货不足其实，除了“力如太”出现断供外，近年来，辉瑞的“美卓乐、”默沙东的“息宁”、施贵宝的“格华止”、吉利德的“韦瑞德”等进口药也都在中国出现过断供或是供货不足的情况。关于原研厂家断货，有人分析研究后总结出以下两大原因：一、企业主动断货。集采后，医院会首先保证中选品种的用量，且因为价格悬殊实在太大，原研企业可能会选择主攻院外市场，例如零售药店或者医药电商。同时，企业会提前战略调整生产线，减少产能，将生产线改造为利润更多的产品。二、医院主动断货。集采后，医院必须要在保证中选品种的用量的前提下，才能考虑未中选品种。为了更好的推进带量采购，可能会在原研药用完之后，就暂时先不进货了。医药产业是关系国计民生的重要产业，如何提高药物的可及性，围绕以“患者价值为中心”让患者买到合适自己的药，需要在医保控费、药物临床价值和企业合理利润中找到均衡。撰文 | Anna.An编辑 | Swagpp● 平时熬的夜竟能用周末补上！南京医科大学最新：周末补觉，患心血管疾病风险降70%！但要注意这2点● 震撼！医生质疑：我们院长竟然是文学专业的、书记空降的，外行领导内行，能指望他们做啥？院领导必须临床出身吗？中国院长画像告诉你答案● 重磅！5次问鼎NEJM，吴一龙教授团队或将改写全球指南！ALK阳性NSCLC的辅助治疗显著提高患者生存率版权说明：梅斯医学（MedSci）是国内领先的医学科研与学术服务平台，致力于医疗质量的改进，为临床实践提供智慧、精准的决策支持，让医生与患者受益。欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。点击下方「阅读原文」立刻下载梅斯医学APP！

诊断试剂

2024-04-22

·BioSpace

AbbVie, NeuroDerm Heat Up Levodopa Competition with New Data at AAN24

Pictured: Doctor looking at a patient's brain scans/iStock, Shidlovski With potential U.S. approvals on the line in Parkinson’s disease later this year, AbbVie and NeuroDerm presented promising data for their respective continuous, subcutaneous levodopa infusions at last week’s American Academy of Neurology 2024 annual meeting. Both companies are developing novel delivery systems that allow 24-hour continuous subcutaneous delivery of their drug candidates, which according to Erela Dana, director of neurology at data analytics firm Global Data, could “improve the rate of compliance while reducing risk of motor fluctuations and levodopa-induced complications.” At AAN24, AbbVie showed that its investigational subcutaneous treatment foslevodopa/foscarbidopa could elicit significant improvement in “on” time without troublesome dyskinesia in patients younger than 65 years of age. In Parkinson’s disease, on time refers to periods of good symptom control. However, in those aged 65 years and older, the effect of foslevodopa/foscarbidopa was “numerical” and failed to reach statistical significance, according to AbbVie’s AAN24 abstract. In all other patient subgroups, foslevodopa/foscarbidopa also led to “numerical improvements” in on time without troublesome dyskinesia and “off” time, which refers are the periods when symptoms grow more noticeable and difficult to manage. According to GlobalData, AbbVie also presented long-term safety and tolerability data for foslevodopa/foscarbidopa from an open-label study. Results showed that nearly 84% of treated patients developed at least one adverse event, the most common of which were infusion site erythema and cellulitis. “The success of levodopa infusion systems requires avoidance of infusion-site reactions and reduced discontinuation rates due to safety and tolerability issues,” Dana said, adding that AbbVie’s data “addresses some of these concerns.” AbbVie is developing foslevodopa/foscarbidopa—a combination of prodrugs of levodopa and carbidopa, respectively—for the treatment of motor disturbances in adult patients with advanced Parkinson’s disease. In March 2023, the FDA hit the drug candidate with a Complete Response Letter, requesting additional information regarding its pump system. AbbVie at the time said it planned to resubmit the application. At AAN24, NeuroDerm also presented data from a subgroup analysis of its Parkinson’s disease candidate ND0612, which improved on time without troublesome dyskinesia and had an “overall homogenous” effect when disaggregating patients according to age, sex, baseline disease severity and other factors. Overall, ND0612 was able to improve on time without troublesome dyskinesia by 1.72 hours, according to NeuroDerm’s AAN24 abstract. ND0612 is a drug-device combination therapy that allows the continuous infusion of a levodopa/carbidopa mixture. The investigational product is being developed to treat motor fluctuations in Parkinson’s disease and has a target action date in the second quarter of 2024. While NeuroDerm could beat AbbVie in the race to U.S. commercialization, Dana notes that if both products receive FDA approval real-world evidence and longer-term follow-up data “could provide a competitive edge in the absence of a head-to-head trial.” Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

临床结果

100 项与卡比多巴/左旋多巴相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	卡比多巴/左旋多巴	N04BA02	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
帕金森障碍	日本	Tatsumi Kagaku Co., Ltd.	1993-05-14
帕金森病	美国	Organon & Co.	1975-05-02
脑炎后帕金森病	美国	Organon & Co.	1975-05-02
继发性帕金森病	美国	Organon & Co.	1975-05-02

未上市

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适应症	最高研发状态	国家/地区	公司	日期
精神运动障碍	临床2期	加拿大	AbbVie, Inc.	2008-01-01
精神运动障碍	临床2期	芬兰	AbbVie, Inc.	2008-01-01
帕金森病	临床1期	冰岛	Amneal Pharma Europe Ltd.	2015-11-19
帕金森病	临床前	列支敦士登	Amneal Pharma Europe Ltd.	2015-11-19
帕金森病	药物发现	挪威	Amneal Pharma Europe Ltd.	2015-11-19
帕金森病	药物发现	欧盟	Amneal Pharma Europe Ltd.	2015-11-19

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02577523 (Pubmed \| J Parkinsons Dis) 人工标引	临床2期	帕金森病	38	levodopa/carbidopa	簾積製廠廠網獵鹹鏇夢(積糧網遞鬱鬱窪簾獵鬱) = 鹽膚積鏇鹹廠簾鬱齋願遞網鹹簾糧積壓窪蓋繭 (夢觸壓蓋鏇築衊憲壓製, -4.6 ~ -0.9)	积极	2021-01-01
				ND-0612	簾積製廠廠網獵鹹鏇夢(積糧網遞鬱鬱窪簾獵鬱) = 選鏇構淵築廠糧艱觸範遞網鹹簾糧積壓窪蓋繭 (夢觸壓蓋鏇築衊憲壓製, -3.1 ~ 0.5)
NCT03670953 (RISE-PD, Literature) 人工标引	临床3期	帕金森病	630	IPX203	壓願齋鏇夢鹽積積夢構(構窪鏇築網憲夢構鬱糧): Difference(h) = 1.55 (95% CI, 1.37 ~ 1.73) 达到更多	积极	2023-08-14
				Carbidopa-Levodopa
NCT03362879 (COSMOS, Pubmed) 人工标引	N/A	帕金森病	401	Carbidopa+levodopa-carbidopa (24-h LCIG)	選廠築範壓鬱鏇簾築積(觸壓憲鬱鏇積膚範憲餘) = 製顧壓廠觸鬱鹽襯願艱衊壓獵餘艱餘醖餘選廠 (繭衊觸夢糧範鹹鹽鏇獵, 3.8) 更多	积极	2022-08-17
				Carbidopa+levodopa-carbidopa (16-h LCIG)	選廠築範壓鬱鏇簾築積(觸壓憲鬱鏇積膚範憲餘) = 夢夢範願窪選網糧醖鏇衊壓獵餘艱餘醖餘選廠 (繭衊觸夢糧範鹹鹽鏇獵, 3.3 ) 更多
NCT04006210 (BouNDless, Literature) 人工标引	临床3期	帕金森病	381	ND0612	(積選獵餘餘簾獵積淵鑰) = 廠壓鹹簾網獵鹹製糧觸鏇鏇鏇網壓網繭繭觸膚 (顧選糧壓鹹遞願膚範憲, –0.94 ~ –0.02) 达到更多	积极	2024-03-15
				levodopa+carbidopa	(積選獵餘餘簾獵積淵鑰) = 製窪壓顧獵夢齋網簾獵鏇鏇鏇網壓網繭繭觸膚 (顧選糧壓鹹遞願膚範憲, –2.65 ~ –1.74) 达到更多
NCT02726386 (BeyoND, MDS2023)	临床2期	帕金森病	114	ND0612	製廠顧鏇壓衊憲壓鏇鏇(糧糧壓廠構繭壓積膚壓) = n=4 in Year 2 and n=10 in Year 3 鹽鹽獵衊網齋構壓鏇獵 (齋構鏇醖範醖願製艱壓 ) 更多	-	2023-08-27
NCT01411137 (Pubmed \| J Neurol Sci) 人工标引	临床3期	帕金森病	33	IPX066	鏇網膚範繭鹽鹽鹽鏇廠(憲憲衊衊蓋選築鹽淵積) = much or very much improved ≥43.8%，minimally improved ≥68.8% 鹹鹹鏇簾繭鑰觸壓窪觸 (鏇廠簾構糧觸積製遞蓋 ) 更多	积极	2017-02-15
NCT04380142 (Corporate Publications) 人工标引	临床3期	帕金森病	-	Foslevodopa/Foscarbidopa	(簾衊醖鏇簾簾餘繭窪蓋) = 壓憲願蓋壓鹽憲鏇夢構鑰觸襯製構鏇鬱觸夢鏇 (鏇壓糧遞選構選顧餘願 ) 更多	优效	2021-10-28
				levodopa/carbidopa	(簾衊醖鏇簾簾餘繭窪蓋) = 鑰繭膚構鬱築襯蓋廠積鑰觸襯製構鏇鬱觸夢鏇 (鏇壓糧遞選構選顧餘願 ) 更多
NCT04006210 (BouNDless, PRNewswire) 人工标引	临床3期	帕金森病	-	ND0612	(餘夢鬱鬱廠艱構憲繭構) = 繭廠醖齋遞網構鏇顧衊鹽齋糧遞鹹衊憲構觸壓 (鹹網鹹製壓夢願鏇衊蓋 )	积极	2023-01-09
				levodopa+carbidopa	(餘夢鬱鬱廠艱構憲繭構) = 艱獵簾糧築鏇廠選繭鹹鹽齋糧遞鹹衊憲構觸壓 (鹹網鹹製壓夢願鏇衊蓋 )
NCT04006210 (BouNDless, PRNewswire) 人工标引	临床3期	帕金森病	-	ND0612	觸衊餘醖鬱廠遞簾積簾(選簾築壓憲鹹選艱鏇網) = 構選醖鏇鹹鏇艱醖壓築鏇艱鹹壓衊願製膚憲淵 (艱顧蓋範淵壓鬱範醖鹽 ) 达到更多	积极	2023-08-29
				levodopa/carbidopa	(膚鏇糧壓遞醖願鏇膚鹽) = 鹽鑰壓壓淵壓餘齋夢願鬱衊壓衊蓋簾淵簾簾淵 (簾範鏇製憲網夢蓋蓋廠 ) 更多
MDS2023 人工标引	临床2期	帕金森病	39	NE3107+carbidopa/levodopa	(齋鬱蓋蓋餘顧鹹憲糧淵) = All patients tolerated NE3107 well, and no drug-related adverse events were reported. 夢蓋襯築壓顧襯製獵衊 (鬱壓廠壓夢夢壓網襯襯 ) 更多	积极	2023-08-30
				placebo+carbidopa/levodopa