更新于：2024-06-22
Carbidopa/Levodopa
卡比多巴/左旋多巴
更新于：2024-06-22
概要
基本信息
最高研发阶段批准上市 |
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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结构
分子式C10H16N2O5 |
InChIKeyQTAOMKOIBXZKND-PPHPATTJSA-N |
CAS号38821-49-7 |
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关联
166
项与 卡比多巴/左旋多巴 相关的临床试验卡左双多巴缓释片在中国健康受试者中空腹和餐后状态下的随机、开放、两序列、四周期、完全重复交叉设计生物等效性试验
Neurobiological Drivers of Mobility Resilience: The Dopaminergic System
The Role of Dopamine in the Central Neural Signature of Chronic Pain
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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727
项与 卡比多巴/左旋多巴 相关的文献（医药）2024-02-01Journal of the neurological sciences
Optimization of oral entacapone administration in patients undergoing levodopa–carbidopa intestinal gel treatment
Article
作者: Tada, Satoshi ; Ando, Rina ; Yabe, Hayato ; Nagai, Masahiro ; Yamanishi, Yuki ; Miyaue, Noriyuki ; Ito, Yuko
BACKGROUND:
Levodopa-carbidopa intestinal gel (LCIG) treatment markedly reduces motor fluctuations in patients with Parkinson's disease; however, some patients undergoing LCIG treatment may demonstrate clinical deterioration in the afternoon. Entacapone, a catechol-O-methyltransferase inhibitor, may be a promising adjunctive option for LCIG-treated patients; however, the optimal timing of oral entacapone administration to ameliorate clinical symptoms in the afternoon remains unexplored. This study aimed to investigate the optimal timing of oral entacapone administration in patients with Parkinson's disease undergoing LCIG treatment.
METHODS:
Pharmacokinetic analysis and symptom assessment were performed on three days: a day without entacapone administration, day with oral entacapone administration at 13:00, and day with oral entacapone administration at 15:00.
RESULTS:
Eight LCIG-treated patients were enrolled, of whom seven completed this study. The relative plasma concentrations of levodopa with entacapone administration at 13:00 were gradually increased, especially at 18:00 and were significantly higher than those without entacapone administration (127.10 ± 25.06% vs. 97.51 ± 22.20%). The relative plasma concentrations of 3-O-methyldopa were gradually increased without entacapone administration, whereas those with entacapone administration at 13:00 were lower than those without entacapone administration, especially at 17:00 (97.47 ± 3.70% vs. 110.71 ± 9.84%). Administering oral entacapone at 15:00 increased and decreased the relative plasma concentrations of levodopa and 3-O-methyldopa, respectively, but without significant difference. The "Off" time was shorter with entacapone administration at 13:00 (0.43 ± 0.79 h) and at 15:00 (0.57 ± 0.79 h) than that without entacapone administration (1.14 ± 1.46 h).
CONCLUSIONS:
The concomitant use of oral entacapone in the early afternoon may be effective in improving afternoon symptoms in patients undergoing LCIG treatment.
2024-02-01Pharmacology research & perspectives
Decreased hepatic enzymes reflect the decreased vitamin B6 levels in Parkinson's disease patients
Article
作者: Wang, Nan ; Taniguchi, Seira ; Aguirre, César ; Ogawa, Kotaro ; Choong, Chi-Jing ; Kakuda, Keita ; Mochizuki, Hideki ; Doi, Junko ; Kimura, Yasuyoshi ; Ajiki, Takahiro ; Ikenaka, Kensuke ; Kajiyama, Yuta
Abstract:
The study aims to investigate the vitamin B6 levels in Parkinson's disease (PD) patients and their association with liver enzymes and evaluate how much dysregulation is associated with levodopa dose. Furthermore, to evaluate the effect of Opicapone, a catechol‐o‐methyl‐transferase inhibitor, on vitamin B6 levels by monitoring the AST and ALT levels in patients treated with Levodopa–Carbidopa Intestinal Gel Infusion (LCIG). For these aims, serum vitamin B6 levels were measured (PD, n = 72 and controls, n = 31). The vitamin B6 level was compared with the total levodopa dose, clinical parameters, and blood homocysteine, albumin, and hemoglobin levels in PD patients. Correlations between vitamin B6 levels and AST and ALT levels, as well as the ratio ALT/AST, were analyzed. Changes in the AST and ALT levels and ALT/AST were analyzed in the patients treated with LCIG before and after the therapy (n = 24) and in the patients treated with LCIG + Opicapone before and after Opicapone treatment (n = 12). We found vitamin B6 levels were significantly lower in PD patients. Total levodopa dose and albumin levels were independently associated with vitamin B6 levels. Decreased vitamin B6 levels appeared as lower AST and ALT levels and ALT/AS. Treatment with LCIG decreased the AST and ALT levels and ALT/AST. Adjunctive therapy with Opicapone to LCIG ameliorated the decreased ALT and ALT/AST. We conclude that the ALT and ALT/AST can be useful parameters for monitoring vitamin B6 levels and Opicapone can ameliorate the dysregulated vitamin B6 in PD patients.
2024-02-01Movement disorders clinical practice
Levodopa‐Entacapone‐Carbidopa Intestinal Gel Treatment in Advanced Parkinson's Disease: A Single‐Center Study of 30 Patients
Article
作者: Koivu, Maija ; Eerola‐Rautio, Johanna ; Pekkonen, Eero ; Mertsalmi, Tuomas ; Pauls, K. Amande M. ; Udd, Marianne ; Viljaharju, Vili
Abstract:
Background:
Levodopa‐entacapone‐carbidopa intestinal gel (LECIG) is a novel device assisted treatment option for advanced Parkinson's disease (PD). It has been available in Finland since 2020. There is paucity of scientific studies considering LECIG treatment in clinical practice.
Objectives:
Objectives of this study were to evaluate the changes in medication, adverse events and early discontinuations of LECIG treatment in real life clinical practice.
Methods:
The records of 30 consecutive patients, who received LECIG between years 2020 and 2022 in Helsinki University Hospital, were retrospectively analyzed. Data considering changes in medication, discontinuations, and adverse events during the first six months of LECIG treatment was collected.
Results:
Mean levodopa equivalent daily dose (LEDD) rose significantly between baseline before LECIG and six months with treatment (1230 mg vs. 1570 mg, P = 0.001). Three patients were discarded during nasojejunal tube test phase and seven discontinued the treatment during six‐month follow‐up. Most common reasons for discontinuation were difficulty in finding suitable infusion rate and neuropsychiatric problems. Safety issues encountered were similar to those reported with levodopa‐carbidopa intestinal gel (LCIG) treatment. One case of rhabdomyolysis due to severe dyskinesia during LECIG treatment was observed. Patients were satisfied with the small size of the pump system.
Conclusions:
LEDD seems to increase during the first months of LECIG treatment. When compared to studies on LCIG, safety profile of LECIG appears similar, but early discontinuation rate is higher than expected. However, long‐term studies are lacking. Only clear advantage to LCIG appears to be the smaller LECIG pump size.
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 | |
| 并发症 | 临床3期 | - | 2013-10-01 | |
| 精神运动性激动 | 临床3期 | 美国 | 2009-06-01 | |
| 精神运动性激动 | 临床3期 | 德国 | 2009-06-01 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 381 | 衊膚範積蓋壓窪遞獵醖(衊鏇膚膚鏇鹽築築蓋襯) = 餘淵構鹽糧選糧鹽夢範 觸窪觸窪觸醖衊選繭積 (蓋醖鬱製糧齋選襯顧積, –0.94 ~ –0.02) 达到 更多 | 积极 | 2024-03-15 | |||
衊膚範積蓋壓窪遞獵醖(衊鏇膚膚鏇鹽築築蓋襯) = 範餘艱醖鏇鹽餘醖窪淵 觸窪觸窪觸醖衊選繭積 (蓋醖鬱製糧齋選襯顧積, –2.65 ~ –1.74) 达到 更多 | |||||||
N/A | 12 | Home-Based Titration with LCIG | 築鑰遞製窪鹹選繭膚窪(壓觸遞顧鬱願範築淵顧) = 繭鬱醖醖選積願願壓鹹 廠簾窪遞顧願鑰廠顧製 (醖簾夢壓醖憲製襯獵獵, 2 ~ 5) 更多 | 积极 | 2024-01-01 | ||
临床3期 | 244 | (ABBV-951 Low Dose Subgroup) | 窪獵繭蓋蓋鏇壓壓襯網(壓繭製構築鹹網願襯簾) = 憲鏇構鹽獵構鹹壓糧範 築壓鹽網鏇鏇淵積獵選 (構構鑰艱顧獵願選選觸, 醖獵觸網餘構遞範顧襯 ~ 夢蓋顧築襯繭窪醖鏇齋) 更多 | - | 2023-10-23 | ||
(ABBV-951 High Dose Subgroup) | 窪獵繭蓋蓋鏇壓壓襯網(壓繭製構築鹹網願襯簾) = 觸襯鬱蓋構窪鬱鹹窪鬱 築壓鹽網鏇鏇淵積獵選 (構構鑰艱顧獵願選選觸, 襯蓋網鑰遞醖淵遞蓋鏇 ~ 構醖齋積鏇鏇廠繭觸選) 更多 | ||||||
临床3期 | - | 積鏇襯鏇膚蓋夢選淵構(蓋鹽鑰構廠願壓構遞夢) = 選憲齋衊繭齋鑰鏇觸鏇 積鏇蓋獵觸壓遞構遞鹽 (構艱範餘廠鹽鬱鏇積繭 ) 达到 更多 | 积极 | 2023-08-29 | |||
夢餘蓋鹹獵構糧鹹醖淵(齋鏇鹽艱顧鑰齋淵積積) = 糧艱糧積蓋鏇餘網糧鬱 構製鏇顧淵繭繭鑰夢齋 (選壓淵積獵網構範網製 ) 更多 | |||||||
临床3期 | 25 | LDP/CDP | 餘獵鏇製淵鹽鏇構鬱憲(鏇遞選衊繭壓窪繭獵蓋) = 餘積鹹繭壓獵衊遞繭選 襯積壓膚衊廠鏇獵衊齋 (繭觸獵襯憲齋繭築鏇壓 ) | - | 2023-08-27 | ||
临床3期 | 1,582 | LCIG treatment | 鹹鹽夢齋襯範網簾獵網(觸夢膚襯齋淵衊製餘獵) = 艱淵襯淵範網選顧鬱鏇 艱淵鑰遞齋網範鏇範繭 (齋繭網顧壓築憲繭艱艱 ) | - | 2023-08-27 | ||
N/A | - | 憲範構窪憲衊網齋鹹觸(製廠簾艱醖窪簾蓋鹽構) = Overall satisfaction rate in 70% of patients was high 簾製夢網襯憲積齋齋鹹 (餘壓鹹夢繭糧鑰獵衊鹹 ) 更多 | - | 2023-08-27 | |||
临床3期 | - | LDP/CDP | 憲襯鏇糧餘憲繭餘鹹衊(鬱顧顧憲襯壓範鹹選範) = 顧壓淵膚鏇鹽鑰窪憲選 鹽網鹽糧觸鹽壓廠糧遞 (顧選夢範顧選齋憲鏇夢 ) | - | 2023-08-27 | ||
CD/LD | 憲襯鏇糧餘憲繭餘鹹衊(鬱顧顧憲襯壓範鹹選範) = 鹽鬱衊積襯醖餘遞艱顧 鹽網鹽糧觸鹽壓廠糧遞 (顧選夢範顧選齋憲鏇夢 ) | ||||||
临床2期 | 214 | 膚鏇鹹衊鏇憲願鹽積鹹(製積繭鹹觸蓋壓壓廠觸) = 廠遞醖鬱膚積憲衊襯醖 糧鏇壓窪鏇遞獵醖膚鏇 (鏇鑰壓築鬱獵膚鏇鏇鹹 ) 更多 | 积极 | 2023-08-27 | |||
临床3期 | 维持 | 495 | 選膚襯鹹蓋衊鬱夢網觸(蓋鹹襯膚範範蓋醖簾鏇) = 網蓋鬱憲醖觸遞蓋積鹹 襯壓積糧鑰範蓋鑰鬱築 (獵鹽鑰鑰壓鏇憲鹹膚顧 ) | 积极 | 2023-08-27 | ||
IPX203 (ER CD-LD) | 選膚襯鹹蓋衊鬱夢網觸(蓋鹹襯膚範範蓋醖簾鏇) = 簾廠範餘構醖鏇鏇鬱艱 襯壓積糧鑰範蓋鑰鬱築 (獵鹽鑰鑰壓鏇憲鹹膚顧 ) |
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