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2023-09-04

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

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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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项与 Neurexan 相关的文献（医药）

2022-11-01·Brain Connectivity4区 · 医学

Nx4 Modulated Resting-State Functional Connectivity Between Amygdala and Prefrontal Cortex in a Placebo-Controlled, Crossover Trial

4区 · 医学

Article

作者: Schultz, Myron ; Jamalabadi, Hamidreza ; Fan, Yan ; Chand, Tara ; Herrmann, Luisa ; Alizadeh, Sarah ; Danyeli, Lena ; Naschold, Britta ; Van der Meer, Johan ; Vester, Johannes C. ; Walter, Martin ; Nanni-Zepeda, Melanni ; Li, Meng

Background: The basic functional organization of the resting brain, assessed as resting-state functional connectivity (rsFC), can be affected by previous stress experience and it represents the basis on which subsequent stress experience develops. Notably, the rsFC between the amygdala and the cortical regions associated with emotion regulation and anxiety are affected during stress. The multicomponent drug Neurexan^® (Nx4) has previously demonstrated a reduction in amygdala activation in an emotional face matching task and it ameliorated stress-related symptoms. We, thus, investigated the effect of Nx4 on rsFC of the amygdala before stress induction compared with baseline in mildly to moderately stressed participants. Methods: In a randomized, placebo-controlled, double-blind, crossover trial 39 participants received a single dose of placebo or Nx4. Resting-state functional magnetic resonance imaging scans were performed pre-dose and 40 to 60 min post-dose, before any stress induction. First, highly connected functional hubs were identified by global functional connectivity density (gFCD) analysis. Second, by using a seed-based approach, rsFC maps of the left centromedial amygdala (CeMA) were created. The effect of Nx4 on both was evaluated. Results: The medial prefrontal cortex was identified as a relevant functional hub affected by Nx4 in an explorative whole brain gFCD analysis. Using the seed-based approach, we then demonstrated that Nx4 significantly enhanced the negative connectivity between the left CeMA and two cortical regions: the dorsolateral and medial prefrontal cortices. Conclusions: In a resting-state condition, Nx4 reduced the prefrontal cortex gFCD and strengthened the functional coupling between the amygdala and the prefrontal cortex that is relevant for emotion regulation and the stress response. Further studies should elaborate whether this mechanism represents enhanced regulatory control of the amygdala at rest and, consequently, to a diminished susceptibility to stress. ClinicalTrials.gov ID: NCT02602275.

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

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

AIMSThe 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 METHODSSixty-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 FINDINGSAll 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.SIGNIFICANCEThe 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.

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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	2023-09-04
应力性骨折	临床1期	德国	Biologische Heilmittel Heel GmbH	2015-08-01

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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


NCT01703819 (NEUPRO-DB, CTgov)	临床1/2期	应力性骨折	66	Neurexan® (Neurexan®)	範網膚襯糧糧鏇窪顧願(願鹽製憲獵範齋鹹蓋淵) = 獵夢鬱鏇糧鹽壓淵鬱艱範積繭簾憲膚齋願壓鏇 (積壓淵糧鑰艱廠醖夢鹹, 夢網餘鹹鏇積觸糧範範 ~ 窪顧遞餘艱齋膚製遞齋) 更多	-	2015-02-11
				Placebo (Placebo)	範網膚襯糧糧鏇窪顧願(願鹽製憲獵範齋鹹蓋淵) = 淵艱膚艱鏇鑰範壓鹹糧範積繭簾憲膚齋願壓鏇 (積壓淵糧鑰艱廠醖夢鹹, 衊夢衊襯積衊膚憲夢願 ~ 顧膚窪齋艱鬱壓鏇製構) 更多