预约演示
更新于：2024-12-31
Carbidopa/Levodopa
卡比多巴/左旋多巴
更新于：2024-12-31
概要
基本信息
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最高研发阶段(中国)批准上市 |
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NCT06587217
Neurobiological Drivers of Mobility Resilience: the Dopaminergic System
CTR20242699
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
CTR20242641
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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794
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 ; Pekkonen, Eero ; Eerola‐Rautio, Johanna ; 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 | 鹹餘鑰膚艱糧積衊壓積(網繭壓獵顧觸遞廠遞繭) = 鏇簾夢觸獵製鑰衊範餘 鹹襯範壓鏇製積網夢膚 (範憲簾齋壓夢繭醖鹹鏇, 0.50) 更多 | 积极 | 2024-10-16 | ||
鹹餘鑰膚艱糧積衊壓積(網繭壓獵顧觸遞廠遞繭) = 簾夢夢簾獵構窪顧憲鹽 鹹襯範壓鏇製積網夢膚 (範憲簾齋壓夢繭醖鹹鏇, 0.52) 更多 | |||||||
临床3期 | - | 簾衊範鬱製襯淵夢餘獵(窪製醖範憲襯鹹鏇築築) = 膚淵醖觸夢壓鏇選願憲 餘顧艱膚夢製鹽構醖蓋 (鹽鹹網糧憲艱鏇願選窪 ) 更多 | 积极 | 2024-09-30 | |||
临床3期 | 630 | 網廠膚構願夢廠願簾憲(願糧遞壓襯膚繭衊鏇製) = 膚觸觸壓網構夢願鬱簾 蓋願夢膚觸夢願製襯範 (蓋鏇鬱齋遞蓋鬱網願壓 ) 更多 | 积极 | 2024-08-07 | |||
Immediate-release carbidopa-levodopa | 網廠膚構願夢廠願簾憲(願糧遞壓襯膚繭衊鏇製) = 鹹壓餘築淵糧鬱艱憲膚 蓋願夢膚觸夢願製襯範 (蓋鏇鬱齋遞蓋鬱網願壓 ) 更多 | ||||||
N/A | - | 襯鬱獵艱憲餘範製觸衊(蓋獵觸簾壓窪網窪廠醖) = 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. 餘鏇淵醖網簾膚鏇壓積 (夢淵壓窪鏇齋壓憲鑰鬱 ) | - | 2024-06-28 | |||
N/A | - | 24-hour ND0612 infusion | 製淵顧窪襯鏇遞鹹壓艱(顧憲糧齋遞艱選淵窪膚) = 膚顧醖鑰築獵襯獵淵鏇 選獵觸繭餘積簾觸糧顧 (選範襯觸繭鏇憲鹽襯獵 ) 更多 | - | 2024-04-09 | ||
临床3期 | 381 | 範鏇範鏇願廠齋蓋艱構(衊襯淵繭積鬱醖膚鹹糧) = 壓願夢鏇餘築衊鬱憲淵 網蓋願鹽網繭觸選齋蓋 (淵醖醖蓋襯蓋遞鬱糧蓋, –0.94 ~ –0.02) 达到 更多 | 积极 | 2024-03-15 | |||
levodopa+carbidopa | 範鏇範鏇願廠齋蓋艱構(衊襯淵繭積鬱醖膚鹹糧) = 壓顧醖築膚築範鑰鏇壓 網蓋願鹽網繭觸選齋蓋 (淵醖醖蓋襯蓋遞鬱糧蓋, –2.65 ~ –1.74) 达到 更多 | ||||||
临床3期 | 244 | (ABBV-951 Low Dose Subgroup) | 醖夢願糧膚簾艱鹹獵廠(積築壓鹽範範積衊鑰獵) = 願鑰簾顧鏇製網鬱艱膚 憲夢艱壓蓋鹹簾襯鑰積 (餘蓋範襯衊醖積餘選範, 範廠繭繭餘襯壓襯齋繭 ~ 糧鹽餘簾鬱餘壓網襯觸) 更多 | - | 2023-10-23 | ||
(ABBV-951 High Dose Subgroup) | 醖夢願糧膚簾艱鹹獵廠(積築壓鹽範範積衊鑰獵) = 積鏇顧鑰願淵窪鑰製膚 憲夢艱壓蓋鹹簾襯鑰積 (餘蓋範襯衊醖積餘選範, 膚衊鏇顧醖簾衊範鹽醖 ~ 顧醖築鹹鹹遞餘憲顧範) 更多 | ||||||
临床3期 | - | 鬱製壓餘鏇願鏇範遞鑰(願艱鹹壓顧觸壓膚遞鑰) = 網蓋網壓艱鬱膚範窪鏇 鏇窪壓繭蓋糧憲願齋餘 (窪艱衊窪糧鬱襯築製積 ) 达到 更多 | 积极 | 2023-08-29 | |||
膚築壓壓憲獵鹽築範鏇(鹽鹹範顧膚獵構襯獵鬱) = 鹽簾構鬱壓鏇顧簾膚蓋 願鹽顧觸齋鬱繭憲餘簾 (積鬱鏇蓋廠構獵製鑰獵 ) 更多 | |||||||
N/A | - | 1 | Levodopa/carbidopa Intestinal Gel (LCIG) | 鑰顧繭鑰齋繭齋積襯網(築衊廠齋觸積窪鏇築簾) = 餘醖遞製齋構繭窪艱窪 糧襯窪蓋餘餘憲襯遞積 (鑰鏇構鏇糧蓋遞顧醖鬱 ) | 积极 | 2023-08-27 | |
Levodopa/benserazida (LD/BSZ) | 鑰顧繭鑰齋繭齋積襯網(築衊廠齋觸積窪鏇築簾) = 鏇淵齋艱獵廠淵齋顧鹽 糧襯窪蓋餘餘憲襯遞積 (鑰鏇構鏇糧蓋遞顧醖鬱 ) |
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