Prospekta(Prospekta) - _专利_临床

概要

基本信息

药物类型

化学药

别名-

靶点-

作用方式-

作用机制-

治疗领域

感染神经系统疾病心血管疾病+ [2]

在研适应症-

非在研适应症

无力注意缺陷障碍伴多动血管性痴呆+ [1]

原研机构

Materia Medica Holding Research And Production Company

在研机构-

非在研机构

OOO NPF Materia Medica HoldingMateria Medica Holding Research And Production Company

权益机构-

最高研发阶段无进展临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

3

项与 Prospekta 相关的临床试验

NCT05074888

/ Completed临床3期

A Multicenter, Double-blind, Placebo-controlled, Parallel-group, Randomized Clinical Trial of Efficacy and Safety of Prospekta in the Treatment of Patients With Post-COVID-19 Asthenia.

The multicenter, double-blind, placebo-controlled, parallel-group, randomized clinical trial.
The objective of this study is to evaluate the efficacy and safety of Prospekta in the treatment of asthenia in patients after the coronavirus infectious disease (COVID-19).

开始日期2021-10-15

申办/合作机构

OOO NPF Materia Medica Holding

NCT04552041

/ Completed临床3期

Multicenter Double-blind Placebo-controlled Randomized Parallel-group Clinical Trial of Efficacy and Safety of Prospekta in the Treatment of Cognitive, Behavioral and Psychiatric Disorders in Patients With Vascular Dementia.

Study purpose:
- evaluate clinical efficacy ands afety of Prospekta in the treatment of cognitive, behavioral and psychiatric disorders in patients with vascular dementia.
Study objectives:
* evaluate and compare changes in cognitive functions, in behavioral and in psychiatric dementia symptoms in Prospekta and Placebo groups after 24-weeks of treatment
* evaluate and compare the frequency, severity and causal relationship of adverse events (AEs) with the type of therapy in Prospekta and Placebo groups (including central nervous system AEs during therapy, their relationship with the study drug and other characteristics).

开始日期2020-12-03

申办/合作机构

OOO NPF Materia Medica Holding

NCT04569357

/ Completed临床3期

Multicenter Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Efficacy and Safety of Prospekta in the Treatment of Attention Deficit/Hyperactivity Disorder in Children

Purpose of the study:
• evaluate the efficacy and safety of Prospekta in the treatment of attention deficit/hyperactivity disorder in children.

开始日期2020-11-20

申办/合作机构

OOO NPF Materia Medica Holding

100 项与 Prospekta 相关的临床结果

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100 项与 Prospekta 相关的转化医学

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100 项与 Prospekta 相关的专利（医药）

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7

项与 Prospekta 相关的文献（医药）

2024-04-23·S.S. Korsakov Journal of Neurology and Psychiatry

Meta-analysis of randomized controlled trials of the effectiveness of Prospekta in the treatment of vascular cognitive impairment of varying severity

Article

作者: Bogolepova, A.N. ; Mkhitaryan, E.A. ; Parfenov, V.A.

Objective. To conduct a meta-analysis of randomized controlled trials (RCTs) to evaluate the efficacy of Prospekta in the treatment of SCI of varying severity. Material and methods. The meta-analysis included the results of RCTs of the efficacy of Prospekta in the treatment of VCI, the severity of which was assessed using the Montreal Cognitive Scale (MoCA). The pooled effect estimate included all publications of double-blind, placebo-controlled RCTs that provided sufficient MoCA efficacy data to support further statistical analysis. The main result of the meta-analysis was obtained for the final values of the efficacy indicator in the groups of patients receiving the drug Prospekta, in comparison with the placebo group. Results. A meta-analysis of the effectiveness of Prospekta in the treatment of SCI of varying severity was carried out based on data from 3 RCTs and 2 CTs involving 12.701 patients aged 18 years and older. When using the mixed models method, the effect size for the endpoint «change in total MoCA score from baseline to follow-up visit» was 3.4 points for Prospekta (2.7 points for placebo, p<0.0001); for the end point «∆ between changes in the total score on the MoCA scale while taking Prospekta and placebo» — 0.6736 points (p<0.0001). Conclusion. A statistically significant improvement in cognitive function according to the MoCA scale was demonstrated in patients with VCI using the drug Prospekta.

2023-12-01·Bulletin of Experimental Biology and Medicine

Safety of the Drug Prospekta: a Preclinical Study of Acute and Repeated Dose Toxicity

Article

作者: Lebedeva, S A ; Bugaeva, L I ; Sundukova, M S ; Kardash, E V ; Tarasov, S A

General toxic effect of the drug Prospekta (modified affinity purified antibodies to the brain-specific S100 protein) was studied on mature male and female mice and rats: acute toxicity with double intragastric and intraperitoneal administration of the maximum permissible doses at a 2-h interval, repeated dose toxicity with intragastric administration of the maximum permissible and close to therapeutic doses for 6 months. No lethal and toxic effects on animals were observed, including no toxic effects on vital systems, i.e., CNS and cardiovascular system, as well systems with the functions that may be temporarily disrupted (excretory and digestive systems). All the differences between animals of the experimental and control groups varied within the physiological range. It can be concluded that the drug produces no general toxic effect on laboratory animals.

2023-11-15·S.S. Korsakov Journal of Neurology and Psychiatry

Therapy of asthenic disorders after psychotic conditions in patients with cognitive impairment: results of an observational non-interventional program

Article

作者: Vanchakova, N.P. ; Parashchenko, A.F. ; Savchenkov, V.A. ; Ushkalova, A.V. ; Chubarovsky, V.V. ; Potapov, I.V. ; Zun, S.A. ; Kolyago, O.O.

Objective. An observational non-interventional study was conducted to obtain data on the efficacy and safety of Prospekta in the treatment of postpsychotic asthenia in patients with cognitive impairment (CI). Material and methods. We selected 69 patients aged 18—75 years with asthenic disorders that developed after suffering psychotic conditions and CI, who were prescribed Prospekta. At four visits (at baseline, after 2, 4 and 8 weeks), the doctor collected complaints, anamnesis, examined the patient, assessed the severity of asthenia on the MFI-20 (The Multidimensional Fatigue Inventory-20) scale, CI — on the MMSE (The Mini-mental state examination). Concomitant diseases and maintenance therapy of the underlying disease were recorded, and the safety of treatment with Prospect was evaluated. At the last visit, the doctor’s clinical impression was assessed using the CGI-I (Clinical Global Impression — Global Improvement Scale). Results. The analysis included data from 69 patients (mean age 45.7 years), of which 27 (33.4%) were women. Prospekta reduced the severity of asthenia on the MFI-20 scale from 85.7±6.6 to 51.6±7.1 points, including general asthenia, mental and physical asthenia, and contributed to an increase in activity and motivation (p<0.001). 8-week treatment with Prospekta improved cognitive function on the MMSE scale from 25.7±3.7 to 28.8±1.5 points (p<0.001). There was no effect of the drug on blood pressure, heart rate. 76 adverse events (AEs) were detected in 22 patients, of which 62 AEs (82%) were of mild severity, 14 AEs (18%) were of moderate severity. A causal relationship of AEs with taking Prospekta, according to doctors, was absent in 48 (63%) cases. Conclusion. Prospekta is an effective and safe drug for the treatment of asthenic disorders that have developed after suffering psychotic conditions in patients with CI.

100 项与 Prospekta 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
无力	临床3期	-	Materia Medica Holding Research And Production Company	2021-10-15
新冠肺炎后遗症	临床3期	俄罗斯	OOO NPF Materia Medica Holding	2021-10-15
血管性痴呆	临床3期	俄罗斯	OOO NPF Materia Medica Holding	2020-12-03
注意缺陷障碍伴多动	临床3期	俄罗斯	OOO NPF Materia Medica Holding	2020-11-20

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04552041 (CTgov)	临床3期	血管性痴呆	406	Prospekta (Prospekta)	衊齋繭顧齋襯鹹選願顧(獵醖齋鬱範遞齋糧願廠) = 糧獵獵廠簾襯廠構積糧鏇餘齋蓋艱窪膚壓鏇構 (築艱構鑰窪獵鹽廠襯繭, 艱構選淵獵淵壓鹹夢餘 ~ 選願膚顧淵衊鏇願製襯) 更多	-	2024-10-28
				Placebo (Placebo)	衊齋繭顧齋襯鹹選願顧(獵醖齋鬱範遞齋糧願廠) = 醖窪膚網齋衊遞壓憲膚鏇餘齋蓋艱窪膚壓鏇構 (築艱構鑰窪獵鹽廠襯繭, 淵願淵壓餘鏇淵衊鑰淵 ~ 鬱膚鬱鏇鹹觸鑰糧選壓) 更多
NCT05074888 (CTgov)	临床3期	新冠肺炎后遗症	676	Prospekta (Prospekta)	鹹膚憲醖鬱夢餘簾積糧(網鹽窪築醖鑰淵壓憲蓋) = 網獵鑰餘觸網衊獵觸淵網廠築廠網願網淵簾蓋 (鑰襯餘繭範夢願壓襯製, 糧製憲網糧顧糧鹹選積 ~ 夢鏇壓衊顧餘窪衊遞糧) 更多	-	2024-09-23
				Placebo (Placebo)	鹹膚憲醖鬱夢餘簾積糧(網鹽窪築醖鑰淵壓憲蓋) = 鹹構積鏇膚範窪衊範壓網廠築廠網願網淵簾蓋 (鑰襯餘繭範夢願壓襯製, 壓艱艱鑰構積鹹繭窪艱 ~ 簾淵餘鏇遞鹹選齋獵夢) 更多
NCT04569357 (CTgov)	临床3期	注意缺陷障碍伴多动	363	Prospekta (Prospekta)	鏇製鑰餘獵選艱襯壓構(蓋簾製鏇鏇鑰鏇廠鏇顧) = 鏇膚憲襯餘願鏇顧壓醖範築願築鏇製蓋積齋夢 (遞鏇鑰顧蓋壓顧壓襯獵, 製鏇膚範艱廠夢壓網觸 ~ 壓鬱廠鏇襯淵艱蓋憲鹹) 更多	-	2024-08-01
				Placebo (Placebo)	鏇製鑰餘獵選艱襯壓構(蓋簾製鏇鏇鑰鏇廠鏇顧) = 築艱遞蓋壓觸壓鹹獵簾範築願築鏇製蓋積齋夢 (遞鏇鑰顧蓋壓顧壓襯獵, 膚壓襯蓋醖顧簾齋鬱夢 ~ 衊遞鏇夢構鏇觸憲範願) 更多