Neurexan(Neurexan) - 在研适应症：紧张症，睡眠-觉醒节律障碍，入睡和睡眠障碍_专利_临床

概要

基本信息

药物类型

中药

别名

Neurexan

靶点-

作用方式-

作用机制-

治疗领域

神经系统疾病其他疾病

在研适应症

紧张症睡眠-觉醒节律障碍入睡和睡眠障碍

非在研适应症

应力性骨折

原研机构

Biologische Heilmittel Heel GmbH

在研机构

Biologische Heilmittel Heel GmbHHeel Chile Ltda.

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

4

项与 Neurexan 相关的临床试验

NCT06278077

/ Active, not recruiting临床2期

Evaluation of the Effects of Neurexan® on Short-Term Insomnia, Daytime Performance and Stress Response by Polysomnography (PSG), Electroencephalogram (EEG), Stress Biomarkers and Patient-Reported Outcomes (PROs)

This clinical study aims to understand the effects of a medication called Neurexan on sleep patterns and stress in people with short-term insomnia. The study involves comparing Neurexan to a placebo - a tablet that looks like Neurexan but lacks active ingredients. The main goal of the study is to determine if Neurexan can enhance sleep efficiency in those with short-term insomnia. Sleep efficiency, which is the proportion of time spent asleep in relation to total time in bed, including attempts to fall asleep, will be assessed through Polysomnography (PSG). PSG examines various sleep characteristics such as brain activity, muscle and heart activity, and breathing.
Participants will take either Neurexan or the placebo for 14 days. Sleep efficiency will be evaluated using PSG before and after the treatment period. Additionally, sleep quality-related factors will be investigated using PSG data, sleep diaries, and participant-completed questionnaires.
The study will also investigate Neurexan's impact on stress levels. This will be assessed using the Cold Pressor Test, which measures stress through having the participant immerse their hand into ice water, and measuring changes in blood pressure and heart rate, both indicators of stress. In addition, blood and saliva samples collected before and after treatment with Neurexan or placebo, will be analyzed for stress-related hormones such as cortisol. Patient questionnaires and Electroencephalography (EEG), a non-invasive brain activity recording, will further assess stress symptoms.
Researchers will analyze data related to sleep efficiency, sleep quality, and stress symptoms. By comparing outcomes before and after Neurexan or placebo treatment, the study aims to detect improvements in these areas. Positive results with Neurexan but not with the placebo would provide robust evidence for Neurexan's efficacy in addressing sleep and stress management issues. This study contributes valuable insights into Neurexan's potential benefits for individuals with short-term insomnia.

开始日期2023-09-06

申办/合作机构

Biologische Heilmittel Heel GmbH

NCT02602275

/ Completed临床2期

Neuronal Correlates of Neurexan® Action in Mildly to Moderately Stressed Probands - A Randomized, Placebo-controlled, Double-blind, Cross-over Trial of Mode of Action and Response Prediction by Functional Magnetic Resonance Imaging MRI

The purpose of this study is to explore the effect of Neurexan® on the brain response when participants undergo an emotional stressful condition in verum compared to placebo.

开始日期2015-08-01

申办/合作机构

Biologische Heilmittel Heel GmbH

NCT01703819

/ Completed临床1/2期

Efficacy Profile of Neurexan® in an Experimental Acute Stress Setting - an Explorative Double-blind Study in Healthy Probands

The purpose of this study is to evaluate the efficacy of acutely dosed Neurexan using an experimental stress test called the Trier Social Stress Test

开始日期2012-10-01

申办/合作机构

Biologische Heilmittel Heel GmbH

100 项与 Neurexan 相关的临床结果

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100 项与 Neurexan 相关的转化医学

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100 项与 Neurexan 相关的专利（医药）

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7

项与 Neurexan 相关的文献（医药）

2022-10-01·Journal of sleep research3区 · 医学

Multicomponent drug Neurexan mitigates acute stress‐induced insomnia in rats

3区 · 医学

Article

作者: Hemmer, Kathrin ; Krömmelbein, Natascha ; Seilheimer, Bernd ; Schmidt, Michelle A. ; Davis, Christopher J.

Summary:

The aim of this study was to determine whether the multicomponent drug Neurexan could mitigate acute insomnia after exposure to a psychosocial stressor. We administered Neurexan orally to rats and examined stress‐induced insomnia using the male rat dirty cage exchange method. The neurocircuitry and electrophysiological correlates of the model are characterised, and it represents various human insomnia conditions. Male rats were randomly assigned in a crossover design to six treatment groups and electroencephalography (EEG) electrodes attached. Three groups were exposed to a cage inhabited by another male rat for a week and the other three groups received a clean cage. Prior to cage change, rats were given either no drug, vehicle control or Neurexan. Non‐rapid eye movement (NREM) sleep, REM sleep, and waking were assessed manually via EEG recordings. Group means were compared for sleep latency and for the 2 h after cage change for: time in each state, state‐specific episode duration/frequency, in addition to NREM delta, gamma and REM theta EEG spectral power. Rats administered Neurexan fell asleep faster than vehicle‐treated rats and spent less time awake with shorter, albeit more waking episodes and increased NREM episodes after dirty cage exposure. Neurexan‐treated rats given dirty cages were not statistically different on any outcomes from Neurexan‐treated rats given clean cages, thereby mitigating the stressor. In the EEG power spectra analysed, changes between treatment groups were not detected. This research confirms that Neurexan treatment has somnogenic effects and ameliorates psychological stressor‐induced acute insomnia.

2016-02-01·Life sciences3区 · 医学

Effects of Neurexan ® in an experimental acute stress setting — An explorative double-blind study in healthy volunteers

3区 · 医学

Article

作者: Rief, W ; Schedlowski, M ; Wegner, A ; Engler, H ; Doering, B K ; Hadamitzky, M

AIMS:

The objective of this study was to assess the efficacy profile of Nx4 (Neurexan ®) in an acute experimental stress setting. An acute stress reaction is a biopsychological condition arising in response to an event that is individually regarded as emotionally stressful. Medications can mitigate stress perception and stress reactions, but may also have side effects.

MATERIALS AND METHODS:

Sixty-four healthy male and female volunteers participated in this prospective two-arm two-site study following an explorative randomized placebo-controlled double-blind study design. Participants took six tablets of either Nx4 or placebo during a time period of 2.5h before exposure to an acute psychological stressor (Trier Social Stress Test), and were subsequently monitored for 1.5h. Subjective stress ratings as well as cardiovascular and neuroendocrine parameters were analyzed before and after stress exposure.

KEY FINDINGS:

All changes in primary and secondary efficacy parameters corresponded well with the experimental acute stress setting. Nx4 did not affect subjective stress ratings but significantly diminished stress-induced increases in salivary cortisol and plasma adrenaline. Nx4 was as safe as placebo and very well tolerated.

SIGNIFICANCE:

The results suggest an attenuated neuroendocrine stress response in healthy volunteers induced by Nx4. However, further investigations are needed to confirm these observations as well as to better understand why some parameters were affected while others were not. Future investigations should be extended to chronically stressed individuals with a greater disposition to experience stress in everyday life. ClinicalTrials.gov Identifier: NCT01703819.

2012-12-01·BMC complementary and alternative medicine

Effect of Neurexan on the pattern of EEG frequencies in rats

Article

作者: Seilheimer, Bernd ; Roeska, Kerstin ; Dimpfel, Wilfried

Abstract:

Background:

Various medications of natural origin have effectively treated stress-related disorders, such as sleep disturbances and agitated conditions. The efficacy of Neurexan, a multicomponent, low-dose medication, has been demonstrated in observational studies, but its exact mechanism of action has not been determined.

Methods:

To characterize the effects of Neurexan on the central nervous system, we analyzed the spectral frequencies of field potentials in four rat brain areas after a single oral administration of Neurexan. Different doses of Neurexan were tested within a crossover design, and effects were compared with vehicle control.

Results:

Significant effects were observed with 0.5 tablets of Neurexan, predominantly on δ- and θ-waves in the frontal cortex and reticular formation (P < 0.01). In the reticular formation, significant changes of δ- and θ-waves occurred as early as during the first hour after administration. The time course revealed a significant and longer-lasting increase of δ- and θ-waves in the frontal cortex and reticular formation, whereas other spectral frequencies were only transiently affected in the frontal cortex, reticular formation, and striatum.

Conclusion:

In conclusion, this study demonstrated that the low-dose medication Neurexan influences central nervous system activity in rats. The resulting electroencephalographic profile of Neurexan shows several similarities with those of other calming agents, such as Valeriana and Passiflora, suggesting a potential benefit of Neurexan for patients with stress-related disorders. Moreover, this report demonstrates that electroencephalographic signatures are also valid biomarkers for the assessment of low-dose medications, such as Neurexan.

100 项与 Neurexan 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,

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适应症	国家/地区	公司	日期
紧张症	德国	Heel Chile Ltda.	-
睡眠-觉醒节律障碍	德国	Heel Chile Ltda.	-

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适应症	最高研发状态	国家/地区	公司	日期
入睡和睡眠障碍	临床2期	德国	Biologische Heilmittel Heel GmbH	2023-06-16
应力性骨折	临床2期	德国	Biologische Heilmittel Heel GmbH	2015-08-01

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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


NCT02602275 (NEURIM, CTgov)	临床2期	应力性骨折	53	Placebo+Neurexan (Neurexan)	繭網構襯窪衊築範蓋餘(糧鏇遞壓獵鑰築鬱願窪) = 鬱鑰廠製獵願網壓製繭鬱選襯顧夢蓋衊壓夢夢 (繭鏇繭衊觸糧積衊選鏇, 0.045) 更多	-	2025-05-08
				Placebo+Neurexan (Placebo)	繭網構襯窪衊築範蓋餘(糧鏇遞壓獵鑰築鬱願窪) = 構蓋壓鑰繭範觸築範蓋鬱選襯顧夢蓋衊壓夢夢 (繭鏇繭衊觸糧積衊選鏇, 0.040) 更多
NCT01703819 (NEUPRO-DB, CTgov)	临床1/2期	应力性骨折	66	Neurexan® (Neurexan®)	繭糧築願鏇衊積壓鹽遞(鏇構艱衊蓋醖顧齋憲選) = 構夢窪糧蓋繭淵憲壓膚蓋壓繭艱窪鏇鹽繭衊築 (鏇鹽遞廠獵積獵餘膚醖, 築繭蓋衊範顧鬱繭簾鹹 ~ 鏇構願積憲鏇壓蓋齋網) 更多	-	2015-02-11
				Placebo (Placebo)	繭糧築願鏇衊積壓鹽遞(鏇構艱衊蓋醖顧齋憲選) = 淵襯窪獵艱窪壓廠蓋蓋蓋壓繭艱窪鏇鹽繭衊築 (鏇鹽遞廠獵積獵餘膚醖, 築鏇構窪繭遞築願襯繭 ~ 襯蓋艱遞餘餘選夢淵襯) 更多