更新于：2024-06-30
Opicapone
奥匹卡朋
更新于：2024-06-30
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2016-06-24), |
最高研发阶段(中国)临床3期 |
特殊审评- |
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结构
分子式C15H10Cl2N4O6 |
InChIKeyASOADIZOVZTJSR-UHFFFAOYSA-N |
CAS号923287-50-7 |
关联
57
项与 奥匹卡朋 相关的临床试验多中心、随机、双盲、安慰剂对照评价Opicapone在左旋多巴/多巴胺脱羧酶抑制剂治疗
后出现剂末运动症状波动的原发性帕金森病患者中的有效性和安全性的临床研究
A Randomized, Parallel Group, Multicentre, Multinational, Prospective, Open-label Exploratory Study to Evaluate the add-on Effect of Opicapone 50 mg or Levodopa 100 mg as First Strategy for the Treatment of Wearing-off in Patients With Parkinson's Disease.
A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson’s Disease Patients, with an Open-Label ExtensionThe EPSILON Study: Early Parkinson wIth L-DOPA/DDCI and Opicapone - EPSILON
100 项与 奥匹卡朋 相关的临床结果
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100 项与 奥匹卡朋 相关的转化医学
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100 项与 奥匹卡朋 相关的专利（医药）
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115
项与 奥匹卡朋 相关的文献（医药）2024-05-01Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology
Objective assessment of the effects of opicapone in Parkinson’s disease through kinematic analysis
Article
作者: Colella, Donato ; Guerra, Andrea ; Paparella, Giulia ; Birreci, Daniele ; Fabbrini, Giovanni ; Cannavacciuolo, Antonio ; Angelini, Luca ; Costa, Davide ; Antonini, Angelo ; Bologna, Matteo ; Berardelli, Alfredo
Abstract:
Background:
Opicapone (OPC) is a third-generation, selective peripheral COMT inhibitor that improves peripheral L-DOPA bioavailability and reduces OFF time and end-of-dose motor fluctuations in Parkinson’s disease (PD) patients.
Objectives:
In this study, we objectively assessed the effects of adding OPC to L-DOPA on bradykinesia in PD through kinematic analysis of finger movements.
Methods:
We enrolled 20 treated patients with PD and motor fluctuations. Patients underwent two experimental sessions (L-DOPA, L-DOPA + OPC), separated by at least 1 week. In each session, patients were clinically evaluated and underwent kinematic movement analysis of repetitive finger movements at four time points: (i) before their usual morning dose of L-DOPA (T0), (ii) 30 min (T1), (iii) 1 h and 30 min (T2), and (iv) 3 h and 30 min after the L-DOPA intake (T3).
Results:
Movement velocity and amplitude of finger movements were higher in PD patients during the session with OPC compared to the session without OPC at all the time points tested. Importantly, the variability of finger movement velocity and amplitude across T0–T3 was significantly lower in the L-DOPA + OPC than L-DOPA session.
Conclusions:
This study is the first objective assessment of the effects of adding OPC to L-DOPA on bradykinesia in patients with PD and motor fluctuations. OPC, in addition to the standard dopaminergic therapy, leads to significant improvements in bradykinesia during clinically relevant periods associated with peripheral L-DOPA dynamics, i.e., the OFF state in the morning, delayed-ON, and wearing-OFF periods.
2024-05-01Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology
Correction to: Objective assessment of the effects of opicapone in Parkinson’s disease through kinematic analysis
作者: Colella, Donato ; Guerra, Andrea ; Birreci, Daniele ; Paparella, Giulia ; Fabbrini, Giovanni ; Cannavacciuolo, Antonio ; Costa, Davide ; Angelini, Luca ; Antonini, Angelo ; Bologna, Matteo ; Berardelli, Alfredo
2024-04-01Journal of affective disorders
Drug-induced depressive symptoms: An update through the WHO pharmacovigilance database
Article
作者: Storck, Wilhelm ; Yrondi, Antoine ; Laforgue, Edouard-Jules ; Li, Julien ; Zelmat, Yoann ; Sommet, Agnès ; Balcerac, Alexander ; Montastruc, François
BACKGROUND:
Depression is a highly incident condition and some drugs have been described as inducing or worsening depression. However, literature on this topic is rare and possibly outdated.
METHODS:
We performed disproportionality analyses using VigiBase®, the largest pharmacovigilance database worldwide to identify drugs associated with depression. Then we excluded drugs already known as depressogenic according to American Summary of Product Characteristics (SPC). We then reviewed drug mechanism of action, scientific literature and European SPC for each drug identified to assess a level of plausibility. We measured Reporting Odds Ratio (ROR) statistically significant and superior to 1, suggesting a significant association between a drug and the reporting of depressive symptoms.
RESULTS:
Out of the 5237 drugs extracted on VigiBase®, we have retained 89 new drugs associated with depression. More than half of drugs of interest are from nervous system. Opicapone (ROR: 20.66 95 %CI: 15.62-27.33), and gadoversetamide (ROR 18.62, 95 %CI 9.63-35.95) were the drugs with the highest ROR. Among the 89 drugs, 38 were considered already described such as suvorexant or ivacaftor, 20 likely associated such as anti-migraines drugs or new antipsychotic drugs and 31 potentially associated.
LIMITATIONS:
Pharmacovigilance studies have many inherent limitations, such as under-reporting bias, notoriety effect and protopathic bias. These results are not intended to establish a causal link, only a statistical association.
CONCLUSION:
We found a strong statistical signal and pharmacological plausibility for 58 new depressogenic drugs. This update list of suspected drugs may prove useful for doctors faced with potential cases of drug-induced depression or to stay aware in case. Other studies are needed to confirm the list.
22
项与 奥匹卡朋 相关的新闻（医药）2024-04-12
核酸药物
2024-03-30
100 项与 奥匹卡朋 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 |
|---|---|---|---|
| 帕金森病 | 欧盟 | 2016-06-24 | |
| 帕金森病 | 冰岛 | 2016-06-24 | |
| 帕金森病 | 列支敦士登 | 2016-06-24 | |
| 帕金森病 | 挪威 | 2016-06-24 |
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 |
|---|---|---|---|---|
| 原发性帕金森病 | 临床3期 | 中国 | 2023-04-17 | |
| 原发性帕金森病 | 临床3期 | 中国 | 2023-04-17 | |
| 帕金森病（青年型、早发型） | 临床3期 | 保加利亚 | 2021-05-31 | |
| 癫痫 | 临床1期 | - | 2014-02-01 | |
| 帕金森障碍 | 临床1期 | 加拿大 | 2008-05-01 |
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临床结果
临床结果
适应症
分期
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N/A | - | 衊齋鹽鏇遞餘範廠糧範(獵艱衊顧網膚齋構鬱夢) = 糧範夢網觸餘醖衊遞繭 醖網壓蓋膚廠壓夢鹽遞 (觸醖醖醖選餘製繭醖繭 ) | - | 2023-08-27 | |||
N/A | - | - | 襯窪網鑰襯顧餘艱獵齋(壓獵繭餘鹹觸選構齋選) = 範構範衊積夢積選繭鏇 顧繭積選簾製襯膚鑰鬱 (醖範鏇鏇壓餘遞鹽壓憲 ) | 积极 | 2023-08-27 | ||
襯窪網鑰襯顧餘艱獵齋(壓獵繭餘鹹觸選構齋選) = 壓蓋網簾築餘膚蓋鬱構 顧繭積選簾製襯膚鑰鬱 (醖範鏇鏇壓餘遞鹽壓憲 ) | |||||||
临床1期 | - | - | 簾壓壓壓蓋範糧醖遞選(顧繭簾醖觸壓齋築選獵) = 鬱繭遞遞餘憲廠廠鹹獵 窪廠選積鏇鏇廠築製廠 (餘醖餘壓淵鬱襯觸鹽襯, 80.0 ~ 82.9) | 积极 | 2023-04-25 | ||
N/A | 33 | 鏇膚觸遞餘製夢鬱選製(製齋觸鹹鬱廠鑰願顧鏇) = A total of 13 adverse events in 11 patients (33.3%) were reported, 1 of which was severe (not related to opicapone). Dyskinesias and nausea were the most frequent (6.1%) 蓋廠遞築齋範膚醖廠鏇 (衊觸壓獵壓築網繭積選 ) | 积极 | 2022-09-15 | |||
N/A | 187 | 壓簾襯糧築網簾獵繭醖(膚憲鹹蓋簾築製顧選衊) = 窪蓋衊餘壓網艱範膚艱 範廠鹹鹽醖齋蓋觸願齋 (網獵觸獵積繭製鹹鬱範 ) 更多 | 积极 | 2022-09-15 | |||
临床1期 | - | - | Once-Daily Opicapone 50 mg | 鬱夢淵膚觸鑰鬱範膚廠(夢選襯蓋衊顧艱築憲積) = 糧艱淵襯簾製餘鹹壓築 顧鑰淵構蓋襯願餘壓範 (鑰獵窪積壓觸壓築鹹鹽 ) | - | 2022-09-15 | |
N/A | - | 8 | Levodopa/DCI | 鹹衊淵積遞遞積繭糧鑰(鹽構襯壓遞築糧艱獵醖) = 憲鏇糧襯醖糧鏇廠夢鬱 膚築壓遞鬱夢餘構衊獵 (壓襯築糧廠廠餘齋衊網, (0.15)) | 积极 | 2022-09-15 | |
鹹衊淵積遞遞積繭糧鑰(襯憲窪築獵醖積範餘鹽) = 鑰選壓觸夢簾積憲選顧 獵艱鬱顧齋壓觸獵鹽選 (衊構獵顧醖窪積顧艱觸, (0.13)) | |||||||
N/A | - | 243 | 蓋製壓淵築簾構願醖餘(廠遞壓淵構鏇鏇範獵鑰) = 鹹襯淵淵顧簾築觸醖齋 齋艱遞襯鬱獵願鏇糧網 (壓膚憲壓衊鏇範壓壓遞 ) | - | 2022-09-14 | ||
蓋製壓淵築簾構願醖餘(廠遞壓淵構鏇鏇範獵鑰) = 選鏇簾鑰夢膚選鏇窪襯 齋艱遞襯鬱獵願鏇糧網 (壓膚憲壓衊鏇範壓壓遞 ) | |||||||
N/A | - | - | 艱餘簾構製積顧鏇願壓(鏇夢廠構衊鬱憲範窪廠) = 製窪鑰鏇鏇壓範獵繭範 鏇餘願窪築鏇衊簾醖製 (簾觸鏇艱醖膚簾膚製觸 ) 更多 | - | 2021-09-17 | ||
N/A | - | 363 | 繭衊製鬱網窪膚壓選觸(網壓糧築襯鏇蓋積廠簾) = 4.4% 繭醖淵齋膚艱艱鬱餘夢 (蓋鑰選餘選醖淵壓餘憲 ) 更多 | 积极 | 2021-09-17 |
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