预约演示
更新于：2025-12-18
Vigabatrin
氨己烯酸
更新于：2025-12-18
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 墨西哥 (2004-04-05), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、优先审评 (中国)、孤儿药 (日本)、临床急需境外新药 (中国) |
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结构/序列
分子式C6H11NO2 |
InChIKeyPJDFLNIOAUIZSL-UHFFFAOYSA-N |
CAS号68506-86-5 |
关联
41
项与 氨己烯酸 相关的临床试验NCT04062890
Inhibiting GABA Transaminase to Relieve Obesity Induced Hyperinsulinemia and Insulin Resistance
CTRI/2025/03/082665
Post-marketing surveillance to determine sociodemographic and clinical variables associated with favorable response to vigabatrin in children with West syndrome - NIL
IRCT20130313012810N32
Bioequivalence study of Vigabatrin 500 mg film coated tablet manufactured by Modava Pharmaceutical Company
100 项与 氨己烯酸 相关的临床结果
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100 项与 氨己烯酸 相关的转化医学
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100 项与 氨己烯酸 相关的专利（医药）
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2,684
项与 氨己烯酸 相关的文献（医药）2026-01-01PEDIATRIC NEUROLOGY
Treatment Practices for Infantile Epileptic Spasms Syndrome: Consensus and Variation in Major Pediatric Epilepsy Centers
Article
作者: Numis, Adam L ; Sirsi, Deepa ; Sandoval Karamian, Amanda G ; Thio, Liu Lin ; Samanta, Debopam ; Hunter, Senyene E ; Catenaccio, Eva ; Harini, Chellamani ; Erdemir, Gozde ; Spriha, Pavuluri ; Shrey, Daniel W ; Hussain, Shaun A ; Donatelli, Stephanie ; Briscoe, Christina ; Planchart Ferretto, Maria A ; Rao, Chethan K ; Katyayan, Akshat ; Singh, Avantika ; Bhatia, Sonal ; Bhalla, Sonam
BACKGROUND:
Infantile epileptic spasms syndrome (IESS) is a developmental and epileptic encephalopathy that requires prompt, effective treatment to optimize outcomes. While the first therapies for IESS with adrenocorticotrophic hormone, prednisolone, or vigabatrin are widely established as a standard, we hypothesized that the treatment protocols of how these therapies should be implemented varied across medical centers.
METHODS:
The Pediatric Epilepsy Research Consortium Infantile Spasms Special Interest Group distributed a REDCap survey to 75 US epilepsy centers. Predefined treatment pathway characteristics were extracted and compared. Standard therapy regimens were defined before data collection.
RESULTS:
Thirty-six centers participated (48% completion rate). Most (89%, n = 32) had IESS treatment pathways, with 72% (n = 23) influenced by insurance barriers such as prior authorizations. Of these, 75% (n = 24) contributed pathways for analysis. Most protocols (88%, n = 21) recommended a standard treatment course for new-onset IESS. Of these, 63% (n = 15) endorsed a sequential approach to using hormonal therapy and vigabatrin, while 17% (n = 4) recommended combination therapy with both for all children. Thirteen centers (54%) provided recommendations for treating persistent epileptic spasms. Approaches to side-effect mitigation varied widely, with gastrointestinal prophylaxis and blood pressure control being the most common (79%, n = 19). Half of the pathways mentioned ketogenic diet (58%) or epilepsy surgery (46%).
CONCLUSIONS:
While there was broad consensus regarding first and second therapy treatment for IESS, variability existed in using sequential versus combination therapy, third therapies, and adverse event monitoring. These findings will guide next research steps in defining key questions on sequential versus combination therapy, third line therapy, and adverse event monitoring in order to develop a standardized consensus-driven treatment protocol for IESS in the future.
2025-12-01PEDIATRIC NEUROLOGY
A Proof-of-Concept Study on Effectiveness of Nitrazepam in Resistant Infantile Epileptic Spasms Syndrome (NitRIS Trial)
Article
作者: Prakash, Kiran ; Sahu, Jitendra Kumar ; Sankhyan, Naveen ; Lal, Parth ; Bansal, Dipika ; Negi, Sandeep
BACKGROUND:
Globally, pediatric neurologists vary in their choice of antiseizure medications for children with infantile epileptic spasms syndrome (IESS) who are resistant to hormonal and vigabatrin therapy. This trial aimed to determine whether oral nitrazepam is more effective than oral topiramate in achieving complete cessation of epileptic spasms (ES) in such cases.
METHODS:
We conducted an open-label, randomized controlled trial with a superiority hypothesis and masked end point assessments. The primary effectiveness end point was complete and sustained cessation of ES for 4 weeks, assessed at 10 weeks post-randomization. Secondary end points included electroclinical remission, time to remission, quality of life (assessed using the Hindi version of the Quality of Life of the Infant scale), autonomic tone (measured via heart rate variability), and adverse events.
RESULTS:
Between June 2023 and December 2024, 80 children with resistant IESS were screened and 40 (29 boys, 11 girls) were randomized to receive oral nitrazepam (0.5-3 mg/kg/day; n = 20) or topiramate (2-12 mg/kg/day; n = 20). Complete cessation of ES was achieved in 55% with nitrazepam vs 15% with topiramate (P = 0.019) and electroclinical remission in 45% vs 10% (P = 0.031). Quality of life scores favored nitrazepam (P = 0.023). Parasympathetic heart rate variability was significantly higher in nitrazepam responders. Sedation was more common with nitrazepam and irritability with topiramate.
CONCLUSIONS:
Nitrazepam showed superior short-term effectiveness over topiramate in resistant IESS, with better quality of life and autonomic stability. Further research is needed to assess long-term outcomes.
2025-12-01PEDIATRIC NEUROLOGY
Neurodevelopmental Outcomes From the PREVeNT Trial
Article
作者: Currans, Kristn ; McPherson, Tarrant O ; McClintock, William M ; Sahin, Mustafa ; Patrick, Kristina E ; Taub, Katherine S ; O'Kelley, Sarah E ; Porter, Brenda E ; Krueger, Darcy A ; Koenig, Mary Kay ; Byars, Anna W ; Capal, Jamie K ; Randle, Stephanie ; Krefting, Jessica L ; Pearson, Deborah A ; Nolan, Danielle A ; Werner, Klaus ; Davis, Peter E ; Cutter, Gary R ; Frost, Michael D ; Wong, Michael ; Bebin, E Martina ; Rajaraman, Rajsekar
BACKGROUND:
Tuberous Sclerosis Complex (TSC) is associated with high prevalence of epilepsy, intellectual and developmental disability, and autism spectrum disorder (ASD). PREVeNT, a Phase IIb, multicenter, double-blind placebo-controlled trial, evaluated the efficacy of vigabatrin in preventing intellectual and developmental disability and ASD in infants with TSC. Phenotypic, developmental, and ASD-specific outcomes at 36 months are presented.
METHODS:
Eighty-four infants with TSC were enrolled in PREVeNT across 13 TSC clinics in the United States. Participants underwent neurodevelopmental assessments at ages 6 months through 36 months. Clinical best estimate diagnosis of ASD or non-ASD along with a rating of clinical certainty was determined at 36 months.
RESULTS:
Sixty-five participants completed assessments through 36 months of age. Mean cognitive scores on the Bayley-III were in the low average range at 12 months. Cognitive scores declined slightly in all groups over time. Adaptive scores were in the low average range for the seizure groups. For all neurocognitive measures, those in the watchful waiting group exhibited higher scores compared to the other cohorts. Language scores became more commensurate with cognitive scores by 36 months. The Clinical Certainty Rating was available for 58 patients, with 31% rated as having ASD; this did not differ by treatment assignment.
CONCLUSIONS:
No significant differences in developmental or autism-specific outcomes were seen between treatment groups, and no participants without epilepsy were diagnosed with ASD. This may be due to early detection of seizures, closer developmental monitoring and follow-up in the trial, and impacts of the pandemic on study participation.
100 项与 氨己烯酸 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 |
|---|---|---|---|
| 癫痫部分性发作 | 欧盟 | 2018-09-20 | |
| 癫痫部分性发作 | 冰岛 | 2018-09-20 | |
| 癫痫部分性发作 | 列支敦士登 | 2018-09-20 | |
| 癫痫部分性发作 | 挪威 | 2018-09-20 | |
| 癫痫发作 | 美国 | 2009-08-21 | |
| 婴儿痉挛 | 美国 | 2009-08-21 | |
| 癫痫 | 墨西哥 | 2004-04-05 |
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 |
|---|---|---|---|---|
| 甲基苯丙胺依赖 | 临床2期 | 美国 | 2008-07-01 | |
| 结节性硬化症 | 临床前 | 美国 | 2024-11-02 |
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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2期 | 4 | 範範憲範鬱襯憲積憲鬱(窪顧繭壓窪襯製顧繭壓) = 鏇願鹽鬱蓋醖顧齋廠糧 顧願製觸淵鏇壓襯鬱醖 (糧淵襯廠獵鬱糧鹹獵選, 1.7) 更多 | - | 2025-01-14 | |||
FDA_CDER 人工标引  | N/A | 40 | 壓鏇築簾糧艱憲顧憲鏇(窪襯餘醖窪襯鬱窪夢製) = 獵淵膚築積齋鑰廠繭鹹 憲積築繭齋觸繭膚壓鏇 (膚遞襯觸遞壓憲醖膚構 ) 更多 | 积极 | 2024-06-17 | ||
placebo | 壓鏇築簾糧艱憲顧憲鏇(窪襯餘醖窪襯鬱窪夢製) = 齋廠衊鹽獵顧憲夢積廠 憲積築繭齋觸繭膚壓鏇 (膚遞襯觸遞壓憲醖膚構 ) | ||||||
FDA_CDER 人工标引 | N/A | 221 | (18-36 mg/kg/day) | 鏇衊構憲築壓廠構製積(鬱醖蓋壓餘簾艱繭餘齋) = 醖衊積獵網蓋廠壓憲廠 餘淵遞艱鏇觸襯範遞鬱 (鹹鏇願範觸繭窪鑰壓網 ) | 积极 | 2024-06-17 | |
(100-148 mg/kg/day) | 鏇衊構憲築壓廠構製積(鬱醖蓋壓餘簾艱繭餘齋) = 網積夢製糧積繭選選夢 餘淵遞艱鏇觸襯範遞鬱 (鹹鏇願範觸繭窪鑰壓網 ) | ||||||
临床2期 | 6 | 齋膚選積築鑰鹽繭網選(積願鬱製襯夢艱艱膚鹹) = 艱憲鬱齋餘繭鬱鑰範壓 齋蓋構範獵鹽網鬱淵憲 (壓範獵廠齋顧廠遞鏇鹽, 262 ~ 1012) 更多 | 积极 | 2024-04-09 | |||
临床2期 | 55 | (Vigabatrin) | 憲製夢衊糧鑰構範顧憲 = 積繭網淵餘繭鬱衊遞衊 淵範醖襯積醖糧選鏇艱 (壓構觸鑰鹹構憲衊積觸, 鑰繭獵鏇繭願網願顧齋 ~ 餘鑰鬱獵鏇鏇鬱網齋壓) 更多 | - | 2020-12-09 | ||
Placebo (Placebo) | 憲製夢衊糧鑰構範顧憲 = 衊鏇範鹹選獵構齋觸壓 淵範醖襯積醖糧選鏇艱 (壓構觸鑰鹹構憲衊積觸, 艱淵顧鑰艱窪鹽膚獵淵 ~ 鹽淵淵鑰壓願壓製鹽鏇) 更多 | ||||||
临床1/2期 | 4 | 鬱鹽構鬱製廠鏇鬱窪齋(壓襯選齋構壓遞夢選鏇) = 艱衊繭鏇窪鹽夢遞窪夢 顧衊獵鹹淵淵構齋積淵 (積壓製壓襯衊艱艱鬱繭, 艱鏇齋夢構壓構顧廠簾 ~ 製製網觸壓築選膚網醖) 更多 | - | 2018-01-19 | |||
N/A | - | 選糧觸築網鏇選繭選觸(願鬱選膚艱醖鹹蓋壓簾) = 蓋齋鏇艱獵積鹽鹽廠醖 糧膚繭遞鏇窪憲淵鹹鑰 (鹽範網鏇蓋廠顧製範艱 ) 更多 | - | 2017-09-03 | |||
临床4期 | 1 | 範顧獵鑰憲獵築觸繭選 = 齋繭窪製網獵鏇壓範願 鬱顧範構衊網製壓餘壓 (遞製廠築夢鹹繭淵遞顧, 廠夢製選鏇積願鹽壓廠 ~ 膚衊壓遞餘鹹獵齋構製) 更多 | - | 2017-07-12 | |||
临床4期 | 65 | 窪餘齋淵壓繭憲鏇艱窪(襯積鏇製衊製膚夢窪夢) = 膚鏇範鏇齋餘鏇鹹願廠 蓋窪艱遞鹹簾構廠壓襯 (範築壓廠襯構衊憲膚艱, 1.06) 更多 | - | 2016-06-07 | |||
临床2/3期 | 207 | (CPP-109 Vigabatrin Tablets) | 願壓艱範齋餘壓襯簾築 = 窪範製餘鏇鹹積壓選構 憲築糧鬱鹹簾顧網鑰繭 (淵鹹鹹選選衊糧蓋壓廠, 艱網積艱壓齋顧醖鹽憲 ~ 鏇構鏇願遞鏇齋淵網範) 更多 | - | 2016-02-23 | ||
Matching Placebo (Placebo) | 夢網簾構憲鹽選獵膚憲 = 構製鬱獵襯鹹網範廠願 製獵壓艱餘構餘壓築顧 (齋觸壓窪廠築鏇顧艱憲, 製艱壓繭餘窪醖鏇顧範 ~ 壓遞艱選膚製繭鹹餘鹽) 更多 |
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