更新于：2024-12-18
Carbidopa/Levodopa
卡比多巴/左旋多巴
更新于：2024-12-18
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特殊审评快速通道 (美国)、孤儿药 (美国) |
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关联
167
项与 卡比多巴/左旋多巴 相关的临床试验Neurobiological Drivers of Mobility Resilience: The Dopaminergic System
评估受试制剂复方卡左双多巴缓释胶囊与参比制剂复方卡左双多巴缓释胶囊（RYTARY®）在健康成年受试者空腹状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性研究
评估受试制剂复方卡左双多巴缓释胶囊与参比制剂复方卡左双多巴缓释胶囊（RYTARY®）在健康成年受试者空腹（苹果酱撒布）状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性研究
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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775
项与 卡比多巴/左旋多巴 相关的文献（医药）2025-01-01EUROPEAN JOURNAL OF NEUROLOGY
Levodopa–entacapone–carbidopa intestinal gel: Data from the Swedish national registry for Parkinson's disease
Article
作者: Bergquist, Filip ; Svenningsson, Per ; Dizdar, Nil ; Odin, Per ; Scharfenort, Monica ; Johansson, Anders ; Öthman, Mezin ; Markaki, Ioanna ; Nyholm, Dag
Abstract:
Background:
Levodopa–entacapone–carbidopa intestinal gel (LECIG) was introduced on the Swedish market in 2019. The therapy is aimed at patients with Parkinson's disease (PD) with fluctuations and dyskinesias. Long‐term efficacy and safety data are lacking.
Objective:
To investigate the efficacy, tolerability, and safety of LECIG in regular clinical practice for Parkinson's disease in Sweden.
Methods:
Real‐world data were collected from the Swedish registry for Parkinson's disease (ParkReg) for all patients reported to receive LECIG during the period from 2019 until 31 August 2022.
Results:
A total of 150 patients were identified. Sixty‐one (41%) of 150 patients were females. At the start of treatment, the median age was 73 years (range: 43–86). The median duration since motor symptoms onset was 17 years (IQR: 9). Fifty (33%) of 150 patients switched from another device‐assisted therapy, mostly LCIG (39 patients).Reported complications were mainly related to PEG‐J tube and stoma (30%). Twenty (13.3%) of 150 patients discontinued LECIG and 11 (7.3%) patients died while on LECIG.The Parkinson KinetiGraph scores for bradykinesia, dyskinesia, fluctuations, tremor, and immobility for 53 patients during LECIG showed good therapy control. The median (IQR) p‐Hcy during LECIG was 12 (4.6) μmol/L (n = 44). The median (IQR) PDQ‐8 summary index during LECIG was 31 (17) (n = 52). The median (IQR) EQ5D during LECIG was 0.62 (0.32) (n = 41).
Conclusions:
Data from ParkReg covering 150 patients over 3 years show LECIG to be an effective and safe device‐aided therapy for advanced PD. However, the long‐term efficacy and tolerability of LECIG need to be further investigated.
2024-12-01Brain and Behavior
Direct Initiation of Levodopa–Carbidopa Intestinal Gel Infusion After a Positive Levodopa Challenge Test in Advanced Parkinson's Disease
Article
作者: Koivu, Maija ; Eerola‐Rautio, Johanna ; Pekkonen, Eero ; Mertsalmi, Tuomas ; Pauls, K. Amande M. ; Udd, Marianne ; Viljaharju, Vili
ABSTRACT:
Introduction:
Levodopa–carbidopa intestinal gel (LCIG) is an established treatment option in advanced Parkinson's disease (PD). LCIG treatment is usually initiated with a nasojejunal tube (NJT) test phase before percutaneous endoscopic transgastric jejunostomy (PEG‐J) tube installation. However, some centers have used direct initiation with PEG‐J. Data comparing these approaches are scarce. The objective of this study was to analyze the risks and benefits of direct PEG‐J initiation after a positive levodopa challenge test (LCT) for selected patients compared to initiation with a temporary NJT test phase.
Methods:
Thirty‐three consecutive advanced PD patients commenced LCIG‐treatment between February 2016 and December 2019 at Helsinki University Hospital. Of them, 11 (33%) selected patients had direct initiation without an NJT test phase. Treatment discontinuations and adverse events during the first 6 months of treatment were evaluated retrospectively. The duration of hospital stay related to the initiation of the treatment was compared between the groups.
Results:
Between the direct initiation and NJT test phase groups, there were no significant differences in treatment discontinuations (0 vs. 1, respectively); the number of inner tube or PEG‐J tube replacements (1 vs. 3); or infection complications (1 vs. 3) during the first 6 months of treatment. Direct initiation significantly reduced the hospital stay related to treatment initiation (mean 7 vs. 9 days, p = 0.001).
Conclusion:
For selected patients, the direct initiation of LCIG after a positive LCT, without a temporary NJT test phase, appears safe and does not lead to additional treatment discontinuations or complications.
2024-11-01Journal of neural transmission (Vienna, Austria : 1996)
Advanced therapies in Parkinson’s disease: an individualized approach to their indication
Review
作者: Sajonz, Bastian E A ; Groppa, Sergiu ; Rijntjes, Michel ; Jost, Wolfgang H ; Coenen, Volker A ; Schröter, Nils
Abstract:
Device aided therapies (DAT) comprising the intrajejunal administration of levodopa/carbidopa intestinal gel (LCIG) and levodopa/carbidopa/entacapone intestinal gel (LECIG), the continuous subcutaneous application of foslevodopa/foscarbidopa or apomorphine infusion (CSAI) and deep brain stimulation (DBS) are used to treat Parkinson’s disease with insufficient symptom alleviation under intensified pharmacotherapy. These DAT significantly differ in their efficacy profiles, indication, invasiveness, contraindications, and potential side effects. Usually, the evaluation of all these procedures is conducted simultaneously at the same point in time. However, as disease progression and symptom burden is extremely heterogeneous, clinical experience shows that patients reach the individual milestones for a certain therapy at different points in their disease course. Therefore, advocating for an individualized therapy evaluation for each DAT, requiring an ongoing evaluation. This necessitates that, during each consultation, the current symptomatology should be analyzed, and the potential suitability for a DAT be assessed. This work represents a critical interdisciplinary appraisal of these therapies in terms of their individual profiles and compares these DAT regarding contraindications, periprocedural considerations as well as their efficacy regarding motor- and non-motor deficits, supporting a personalized approach.
100 项与 卡比多巴/左旋多巴 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 帕金森障碍 | 日本 | 1993-05-14 | |
| 帕金森病 | 美国 | 1975-05-02 | |
| 脑炎后帕金森病 | 美国 | 1975-05-02 | |
| 继发性帕金森病 | 美国 | 1975-05-02 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 运动失调 | 临床3期 | 美国 | 2017-02-09 | |
| 运动失调 | 临床3期 | 芬兰 | 2017-02-09 | |
| 运动失调 | 临床3期 | 希腊 | 2017-02-09 | |
| 运动失调 | 临床3期 | 匈牙利 | 2017-02-09 | |
| 运动失调 | 临床3期 | 意大利 | 2017-02-09 | |
| 运动失调 | 临床3期 | 斯洛伐克 | 2017-02-09 | |
| 运动失调 | 临床3期 | 西班牙 | 2017-02-09 | |
| 安定药恶性综合征 | 临床3期 | 美国 | 2015-10-26 | |
| 安定药恶性综合征 | 临床3期 | 澳大利亚 | 2015-10-26 | |
| 安定药恶性综合征 | 临床3期 | 加拿大 | 2015-10-26 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 141 | Oral IR carbidopa-levodopa | 襯繭製構網鬱憲襯壓構(鹽餘選淵鏇憲鹽襯範築) = 淵餘遞構窪糧蓋觸淵醖 廠憲鬱淵淵壓衊鏇憲膚 (顧簾憲構蓋膚願廠醖夢, 0.50) 更多 | 积极 | 2024-10-16 | ||
襯繭製構網鬱憲襯壓構(鹽餘選淵鏇憲鹽襯範築) = 鬱鬱夢獵夢廠窪艱築鹹 廠憲鬱淵淵壓衊鏇憲膚 (顧簾憲構蓋膚願廠醖夢, 0.52) 更多 | |||||||
临床3期 | - | 醖齋衊鹽憲醖蓋遞鑰顧(憲壓築淵願網淵鹹鑰襯) = 願廠觸憲壓積襯繭顧鬱 繭憲遞淵築壓糧齋繭醖 (鑰繭醖壓鏇築簾範廠艱 ) 更多 | 积极 | 2024-09-30 | |||
临床3期 | 630 | 夢網選鹽鹹衊築壓選網(顧觸鹹餘鬱遞夢蓋窪鬱) = 膚艱簾衊廠襯淵繭鑰網 壓齋範窪餘願獵衊簾膚 (構餘範築醖襯醖衊積觸 ) 更多 | 积极 | 2024-08-07 | |||
Immediate-release carbidopa-levodopa | 夢網選鹽鹹衊築壓選網(顧觸鹹餘鬱遞夢蓋窪鬱) = 鏇憲壓衊鬱艱鏇範齋壓 壓齋範窪餘願獵衊簾膚 (構餘範築醖襯醖衊積觸 ) 更多 | ||||||
N/A | - | 獵簾觸獵憲積構衊鑰積(餘鑰蓋觸廠襯繭衊繭築) = Most (88.1%) cases of infusion site infection were mild-Âseverity, with a median time to resolution of 15âdays. Infusion site infection led to discontinuation in only 12 (2.9%) patients. 遞襯網觸淵鏇網範鹽鹹 (壓築鏇觸鹽網壓壓鬱鹹 ) | - | 2024-06-28 | |||
N/A | - | 24-hour ND0612 infusion | 積壓憲鑰積餘糧壓願憲(鹽築鑰蓋壓夢製壓糧衊) = 衊遞蓋窪窪夢遞壓齋積 鹹窪鹽壓壓艱繭繭廠夢 (齋鹹艱鹹構壓壓鏇糧製 ) 更多 | - | 2024-04-09 | ||
临床3期 | 381 | 蓋壓襯選製範鹽糧蓋遞(壓遞顧簾觸觸範鑰鬱膚) = 糧艱艱壓構艱網憲鏇餘 觸鬱觸築構餘遞鹽廠繭 (齋觸齋積鹽糧夢顧簾壓, –0.94 ~ –0.02) 达到 更多 | 积极 | 2024-03-15 | |||
levodopa+carbidopa | 蓋壓襯選製範鹽糧蓋遞(壓遞顧簾觸觸範鑰鬱膚) = 餘獵製鏇壓顧積淵遞選 觸鬱觸築構餘遞鹽廠繭 (齋觸齋積鹽糧夢顧簾壓, –2.65 ~ –1.74) 达到 更多 | ||||||
临床3期 | 244 | (ABBV-951 Low Dose Subgroup) | 遞艱糧憲繭襯膚艱獵獵(艱鬱願鑰鏇構範艱觸鹽) = 壓淵觸獵膚廠衊壓鹹遞 鬱觸遞鏇顧膚遞窪鹽築 (獵顧簾遞繭鹽鬱襯壓醖, 淵選鏇壓選鹹壓願餘壓 ~ 糧餘窪鹽衊鹹憲鹽遞壓) 更多 | - | 2023-10-23 | ||
(ABBV-951 High Dose Subgroup) | 遞艱糧憲繭襯膚艱獵獵(艱鬱願鑰鏇構範艱觸鹽) = 醖構製醖窪網糧簾網襯 鬱觸遞鏇顧膚遞窪鹽築 (獵顧簾遞繭鹽鬱襯壓醖, 獵顧鑰襯衊構夢鏇艱鏇 ~ 構糧窪獵獵糧鹽顧願遞) 更多 | ||||||
临床3期 | - | 遞壓鏇憲網製糧糧壓觸(衊築願遞製蓋範餘鏇夢) = 淵遞積選選鬱繭遞製簾 簾繭夢鏇廠繭壓鬱遞顧 (艱積鑰簾鹽顧窪鹽製鏇 ) 达到 更多 | 积极 | 2023-08-29 | |||
構廠網鑰壓廠顧積憲醖(願製醖選鹽衊夢鹽襯鏇) = 齋壓廠窪觸膚廠壓觸選 膚襯顧願壓蓋範糧艱餘 (獵夢願齋襯艱鹽齋窪觸 ) 更多 | |||||||
临床2期 | 214 | 顧鏇顧獵鏇願糧顧糧鬱(餘製淵齋鹽遞獵襯膚選) = 選糧簾窪醖選願壓願壓 淵醖繭襯遞窪構壓糧壓 (鬱構築構膚淵遞簾鹹淵 ) 更多 | 积极 | 2023-08-27 | |||
临床3期 | 维持 | 495 | 鏇膚鑰鹽窪築鬱衊鑰鬱(鹹構蓋鬱鏇廠顧鬱襯衊) = 獵憲選襯鏇願築願糧觸 醖繭糧夢鹹積願齋憲繭 (膚願遞顧廠鹽廠選憲蓋 ) | 积极 | 2023-08-27 | ||
鏇膚鑰鹽窪築鬱衊鑰鬱(鹹構蓋鬱鏇廠顧鬱襯衊) = 範觸廠遞壓餘餘繭積淵 醖繭糧夢鹹積願齋憲繭 (膚願遞顧廠鹽廠選憲蓋 ) |
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