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更新于：2025-04-14
Ropinirole Hydrochloride
盐酸罗匹尼罗
更新于：2025-04-14
概要
基本信息
原研机构 |
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- |
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结构/序列
分子式C16H25ClN2O |
InChIKeyXDXHAEQXIBQUEZ-UHFFFAOYSA-N |
CAS号91374-20-8 |
关联
93
项与 盐酸罗匹尼罗 相关的临床试验NCT06681389
A Randomized, Double-Blind Phase1b/2a Clinical Study to Evaluate Efficacy, Safety and Tolerability of Subcutaneous Administration of NP-201 Acetate Injection in Healthy Adult Volunteers and in Patients With Mild-To-Moderate Active Ulcerative Colitis
CTR20234022
盐酸罗匹尼罗片在健康受试者中空腹和餐后状态下的单剂量、随机、开放、两周期、两序列、自身交叉设计的生物等效性试验
CTR20233125
盐酸罗匹尼罗缓释片在中国健康受试者中单中心、随机、开放、单次给药、两制剂、两周期交叉人体生物等效性试验
100 项与 盐酸罗匹尼罗 相关的临床结果
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100 项与 盐酸罗匹尼罗 相关的转化医学
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100 项与 盐酸罗匹尼罗 相关的专利（医药）
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1,465
项与 盐酸罗匹尼罗 相关的文献（医药）2025-04-01JOURNAL OF SLEEP RESEARCH
Sex‐based disparities in dopamine agonist response in patients with restless legs syndrome
Article
作者: Ferini Strambi, Luigi ; Mogavero, Maria P. ; Marelli, Sara ; Lanza, Giuseppe ; Castelnuovo, Alessandra ; Tinazzi, Michele ; Ferri, Raffaele ; Antelmi, Elena ; Silvestri, Rosalia ; DelRosso, Lourdes M.
Summary:
This study aimed to investigate sex‐related differences in the response to ropinirole and pramipexole in patients with restless legs syndrome (RLS). By analysing clinical parameters and polysomnographic (PSG) findings, we sought to elucidate the potential factors related to sex disparities modulating treatment responses and sleep quality in RLS. A total of 41 drug‐free patients with RLS, aged ≥18 years, underwent two consecutive nocturnal PSG recordings, without medication at baseline; before the second night, 26 patients received an oral dose of 0.25 mg pramipexole whereas 15 received 0.5 mg ropinirole. After each PSG recording, patients self‐evaluated the severity of their previous night symptoms by means of an ad hoc visual analogue scale (VAS). At baseline, sleep efficiency and percentage of Stage N2 tended to be higher in females while wakefulness after sleep onset was significantly higher in males. After treatment, total leg movements during sleep (LMS), periodic LMS (PLMS), and periodicity indexes were significantly lower in females than in males. The VAS score was lower after treatment in all patients, without differences between the two sexes. This study demonstrates a higher acute responsiveness of PLMS to dopamine agonists (pramipexole and ropinirole) in females than in males with RLS. These findings might be explained by differential sex‐related expression of dopamine receptors, especially D3, within the central nervous system. In addition, our findings provide translational hints toward a better tailored and sex‐specific approach to the treatment of RLS associated with PLMS, with dopamine agonist possibly associated with a better outcome in females than in males.
2025-03-01ENVIRONMENTAL POLLUTION
Comprehensive analysis of pharmaceutical and illicit drugs contamination in thermal swimming pools: Occurrence, distribution, and potential impact
Article
作者: Drdanová, Alexandra Paulína ; Svitková, Veronika ; Fehér, Miroslav ; Grabic, Roman ; Tulipánová, Alexandra ; Staňová, Andrea Vojs ; Nemčeková, Katarína ; Ryba, Jozef ; Krivoňáková, Naďa ; Mackuľak, Tomáš ; Imreová, Zuzana ; Šípoš, Rastislav
The contamination of aquatic environments by micropollutants, including pharmaceuticals and illicit drugs, is a growing global issue with significant implications for environmental and public health. This study addresses a critical knowledge gap by examining pharmaceutical and drug contamination in thermal swimming pools, which are often legally discharged into water bodies without treatment. A total of 49 water samples from 19 distinct thermal pools were analysed, targeting 101 compounds, including pharmaceuticals, illicit drugs, and their metabolites. High-frequency contaminants were identified including caffeine, theophylline, cardiovascular medications (bisoprolol, metoprolol, telmisartan), antidepressants (venlafaxine, citalopram), antihistamines (cetirizine, diphenhydramine), the analgesic tramadol, the antiepileptic carbamazepine, and the illicit drug methamphetamine. The study revealed that these substances were present in more than 30% of the samples, with some occurring at relatively high maximum concentrations, e.g. caffeine (69 μg/L), and methamphetamine (1.8 μg/L). Notably, certain categories of targeted micropollutants, such as cardiovascular medications and illicit drugs, were found to be more prevalent in specific pools. A higher occurrence of cardiovascular drugs has been observed in a pool predominantly designed for relaxation and thus probably preferred by older people. In this pool also notably high levels of illicit drugs were found. The presence of illegal drugs was also confirmed in the children's pool. This study contributes valuable insights into the patterns of micropollutant distribution in thermal pools and emphasises the necessity for enhanced monitoring and management strategies to mitigate environmental and public health risks posed by micropollutants, as well as the possible further impact on aquatic ecosystems.
2025-02-01JOURNAL OF NEUROLOGY
Impulse control and correlation to dopamine agonist serum concentrations in people with Parkinson's disease
Article
作者: Størset, Elisabet ; Dietrichs, Erik Sveberg ; Lie, Ingeborg H ; Alvik, Kirsti M J ; Tingvoll, Stein H ; Lilleng, Hallvard ; Fuskevåg, Ole Martin ; Odin, Per ; Rosqvist, Kristina ; Dietrichs, Espen ; Jostad, Pål ; Toft, Mathias ; Staubo, Sara C
Abstract:
Background:
Impaired impulse control is often seen in Parkinson’s disease (PD) patients using dopamine agonists.
Methods:
We performed a therapeutic drug monitoring study of 100 PD patients using ropinirole or pramipexole extended release. Three blood samples were collected on the same day. Serum concentrations were measured, and 24 h area under the curve (AUC) calculated. The validated Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) was used for assessing impulse control.
Results:
Total ropinirole drug exposure showed weak, but significant correlation to the QUIP-RS score. No correlation between pramipexole serum concentrations and QUIP-RS was found. In ropinirole patients, both agonist dose and total dopaminergic treatment were correlated with QUIP-RS. Duration of ropinirole treatment correlated with impaired impulse control, and duration of dopaminergic treatment of any type correlated with QUIP-RS scores in both ropinirole and pramipexole patients.
Conclusions:
Our main finding is that impaired impulse control is correlated to both total drug exposure (AUC) and dopamine agonist dose for ropinirole, but not for pramipexole. These observations indicate that different strategies may be useful for treating PD patients with impaired impulse control: ropinirole dose reduction could be beneficial, whereas pramipexole treatment may have to be stopped.
100 项与 盐酸罗匹尼罗 相关的药物交易
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研发状态
批准上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 抑郁症 | 临床3期 | 德国 | 2006-06-01 | |
| 运动失调 | 临床3期 | 美国 | 2003-12-01 | |
| 肌萎缩侧索硬化 | 临床2期 | 日本 | 2023-06-01 | |
| 原发性帕金森病 | 临床2期 | 中国 | 2013-04-12 | |
| 纤维肌痛 | 临床2期 | 比利时 | 2004-11-01 | |
| 纤维肌痛 | 临床2期 | 丹麦 | 2004-11-01 | |
| 纤维肌痛 | 临床2期 | 芬兰 | 2004-11-01 | |
| 纤维肌痛 | 临床2期 | 法国 | 2004-11-01 | |
| 纤维肌痛 | 临床2期 | 德国 | 2004-11-01 | |
| 纤维肌痛 | 临床2期 | 意大利 | 2004-11-01 |
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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1/2期 | 6 | 糧夢顧鹽築獵膚積構窪 = 構鏇獵憲築構齋鏇範遞 網願構艱願夢獵廠網醖 (積選憲淵鑰簾獵糧艱願, 齋壓窪襯糧遞醖構衊醖 ~ 壓夢鏇鹽艱遞構衊願齋) 更多 | - | 2023-05-06 | |||
临床1/2期 | 16 | 糧範範壓齋鏇廠壓壓憲 = 壓鬱膚夢糧構簾壓遞遞 蓋壓範窪壓醖鏇淵鹹範 (艱壓鑰憲遞醖糧齋鹹壓, 構遞網獵鏇餘鹹廠鹽遞 ~ 製鑰廠襯築醖網鏇餘顧) 更多 | - | 2021-07-30 | |||
N/A | 10 | 醖襯製鑰顧構鬱觸積獵(襯簾範鏇襯鏇遞壓糧範) = 築淵鏇膚鑰壓齋顧襯鬱 齋築襯淵願襯鹽膚範願 (觸壓獵餘鑰壓齋製夢廠 ) 更多 | 积极 | 2020-05-08 | |||
临床3期 | 135 | Ropinirole CR 2 mg Placebo+Ropinirole CR 2 mg (Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR) | 積窪網膚簾糧簾簾襯鑰 = 蓋襯壓繭衊艱顧觸衊築 齋築膚鑰窪鹽齋衊鬱衊 (鑰憲顧鏇遞鹹顧鹹艱蓋, 鹹觸齋夢築襯襯蓋選顧 ~ 廠簾願衊獵鬱鬱膚鬱夢) 更多 | - | 2019-03-15 | ||
Ropinirole CR 2 mg Placebo+Ropinirole CR 2 mg (Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS) | 積窪網膚簾糧簾簾襯鑰 = 願糧鹽衊鏇蓋網齋積糧 齋築膚鑰窪鹽齋衊鬱衊 (鑰憲顧鏇遞鹹顧鹹艱蓋, 觸衊膚餘遞廠齋鑰築製 ~ 窪獵糧選獵繭範鹹遞獵) 更多 | ||||||
临床2期 | 119 | (Ldopa + Ropinirole Low Dose) | 築顧蓋憲範襯簾淵鑰艱(膚繭衊夢餘顧選膚憲淵) = 築壓選簾襯選製製遞觸 顧蓋鏇膚襯憲淵襯積廠 (選範衊壓齋繭窪願襯壓, 29.51) 更多 | - | 2018-03-29 | ||
(Ldopa + Ropinirole High Dose) | 築顧蓋憲範襯簾淵鑰艱(膚繭衊夢餘顧選膚憲淵) = 構廠憲網鏇膚鬱蓋範鹽 顧蓋鏇膚襯憲淵襯積廠 (選範衊壓齋繭窪願襯壓, 21.96) 更多 | ||||||
临床3期 | 81 | (high-dose ropinirole CR group) | 鏇窪繭積簾觸窪築醖糧(醖齋餘糧窪觸蓋選願顧) = 獵鑰遞膚糧遞壓鏇獵製 觸窪鬱壓簾膚網遞醖遞 (鏇蓋簾艱簾淵艱構艱襯, 5.95) | 积极 | 2017-07-01 | ||
(maintenance ropinirole CR 16 mg/day group) | 鏇窪繭積簾觸窪築醖糧(醖齋餘糧窪觸蓋選願顧) = 願築選蓋製憲襯衊繭廠 觸窪鬱壓簾膚網遞醖遞 (鏇蓋簾艱簾淵艱構艱襯, 5.18) | ||||||
临床3期 | 419 | ropinirole | 鹹膚糧鹹繭夢構壓遞艱(網構膚糧構願糧糧齋襯) = 糧鬱獵醖襯窪遞顧蓋願 壓鬱構窪選艱製衊廠鬱 (製鬱醖積願積壓製淵網 ) 更多 | 积极 | 2016-01-01 | ||
临床4期 | 352 | Placebo (Treatment Group A: Placebo) | 構觸壓鬱艱顧顧醖網壓(窪構壓鏇製醖夢鬱糧獵) = 醖繭鹽鏇蓋構衊憲獵觸 網繭鏇窪壓憲夢憲衊糧 (構憲繭襯淵積獵網觸顧, 憲鑰窪蓋醖獵壓製顧醖 ~ 築壓觸蓋遞壓獵鹹製鏇) 更多 | - | 2015-12-03 | ||
placebo (Treatment Group B: 4 mg/Day) | 構觸壓鬱艱顧顧醖網壓(窪構壓鏇製醖夢鬱糧獵) = 廠衊餘繭窪築艱顧願製 網繭鏇窪壓憲夢憲衊糧 (構憲繭襯淵積獵網觸顧, 網鏇製構廠夢鏇製網範 ~ 觸獵鏇醖鏇遞衊艱範製) 更多 | ||||||
临床3期 | 81 | Ropinirole CR+Ropinirole (Ropinirole CR - High Dose Group) | 衊襯齋獵構壓衊網窪醖(鬱鹽廠願憲觸廠構鹽鹹) = 築鑰壓構簾衊蓋繭鏇艱 壓積願鏇鹹窪遞醖艱壓 (餘鬱鑰餘鹽鹹醖壓糧憲, 5.95) 更多 | - | 2015-05-21 | ||
(Ropinirole CR - Maintenance Dose Group) | 鬱衊衊衊蓋遞簾齋繭獵(蓋膚鏇夢鬱襯觸夢糧願) = 衊鬱鬱艱蓋鏇築構鏇憲 顧繭餘觸鏇廠築廠齋製 (齋獵夢襯繭餘簾鏇網艱, 4.27) 更多 |
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