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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002359-40 | EudraCT Number |
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The purpose of this study is to explore the efficacy of acutely dosed Neurexan using an experimental stress test called the Trier Social Stress Test
An acute stress reaction is a biopsychological condition arising in response to an event which is individually regarded as emotionally stressful. The onset of a stress response is associated with specific physiological actions in the sympathetic nervous system, both directly and indirectly through the release of adrenaline and to a lesser extent noradrenaline from the medulla of the adrenal glands. These catecholamine hormones facilitate immediate physical reactions by triggering increases in heart rate and breathing, constricting blood vessels. The other major player in the acute stress response is the hypothalamic-pituitary-adrenal axis.
Although stress has been described as a non-specific psychophysiological response to environmental stimuli, it is possible to discern specific bodily stress responses caused by specific emotional reactions to novel, ambivalent or uncontrollable situations and stimuli. For example, social stress induces elevated cortisol levels, particularly if the stressor is uncontrollable, unpredictable, and constitutes a social-evaluative threat due to the judgment of others such as in the Trier Social Stress Test). Usually, the TSST induces a two-fold increase in saliva cortisol with peaks around 10-20 min. after stress test termination. Also, an average increase in heart rates of around 20 beats per minute (bpm) is observed during the TSST. In addition, emotional states and feelings have been shown to be affected by this stress test, such as marked increases in stress perception,anxiety and emotional insecurity as well as decreases in mood, calmness and feeling awake.
Preliminary results indicate that Neurexan® may improve coping abilities in stressful situations. This study aims to investigate the effect of Neurexan® on subjectively perceived nervousness and tension during an acute stressful situation and to characterize the efficacy profile of Neurexan®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurexan® | Experimental | 0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes |
|
| No intervention | No Intervention | no tablet intake and subjects will undergo the natural course |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurexan® | Drug | 0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Stress Measured by Tension | Tension and nervousness were self-assessed by the participants on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) before and after a stress test. The VAS is used to determine the subjective impression of tension and nervousness on a 10 cm bipolar visual scale ranging from 0 = "not at all" to 100 = "highly". The measurements started with first intake of Neurexan or Natural Course and were repeated until 100 minutes after the end of the stress test. The total stress was then summarized with the Area under the curve (AUC) method. | -210 minutes to +100 minutes |
| Acute Stress Measured by Nervousness | Tension and nervousness were self-assessed by the participants on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) before and after a stress test. The VAS is used to determine the subjective impression of tension and nervousness on a 10 cm bipolar visual scale ranging from 0 = "not at all" to 100 = "highly". The measurements started with first intake of Neurexan or Natural Course and were repeated until 100 minutes after the end of the stress test. The total stress was then summarized with the Area under the curve (AUC) method. | -210 minutes to +100 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Saliva Alpha Amylase | The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test. | -60 minute, +15 minute , + 45 minute, +100 minute |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manfred Schedlowski, PhD | Institut für Medizinische und Verhaltensimmunbiologie Universitätsklinikum Essen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut fur Medizinische Psychologie und Verhaltensimmunbiologie Universitatsklinikum Essen | Essen | 45122 | Germany | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17615391 | Background | McEwen BS. Physiology and neurobiology of stress and adaptation: central role of the brain. Physiol Rev. 2007 Jul;87(3):873-904. doi: 10.1152/physrev.00041.2006. | |
| 16952284 | Background | Elsenbruch S, Lucas A, Holtmann G, Haag S, Gerken G, Riemenschneider N, Langhorst J, Kavelaars A, Heijnen CJ, Schedlowski M. Public speaking stress-induced neuroendocrine responses and circulating immune cell redistribution in irritable bowel syndrome. Am J Gastroenterol. 2006 Oct;101(10):2300-7. doi: 10.1111/j.1572-0241.2006.00837.x. Epub 2006 Sep 4. |
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All 65 healthy participants were enrolled and none were excluded prior to randomization.
Recruitment was carried out in 2 outpatient clinics in Germany (Marburg and Essen).
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| ID | Title | Description |
|---|---|---|
| FG000 | Neurexan® | At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours. |
| FG001 | No Intervention | At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
33 participants were randomized to Neurexan and 32 participants to Natural Course. All randomized participants were included in the Safety Set. One premature terminator could not be evaluated for primary efficacy, so 32 participants in the Neurexan group and 32 participants in the Natural Course group formed the Full Analysis Set for efficacy.
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| ID | Title | Description |
|---|---|---|
| BG000 | Neurexan® | At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours. |
| BG001 | No Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 33 participants were randomized to Neurexan and 32 participants to Natural Course. All randomized participants were included in the Safety Set. One premature terminator could not be evaluated for primary efficacy, so 32 participants in the Neurexan group and 32 participants in the Natural Course group formed the Full Analysis Set for analysis of efficacy. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acute Stress Measured by Tension | Tension and nervousness were self-assessed by the participants on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) before and after a stress test. The VAS is used to determine the subjective impression of tension and nervousness on a 10 cm bipolar visual scale ranging from 0 = "not at all" to 100 = "highly". The measurements started with first intake of Neurexan or Natural Course and were repeated until 100 minutes after the end of the stress test. The total stress was then summarized with the Area under the curve (AUC) method. | 33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy. | Posted | Median | Full Range | mm*min | -210 minutes to +100 minutes |
|
Randomization until individual study end
All adverse events that occurred after the participant has received at least one dose of the product under investigation were to be collected and reported
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neurexan® | At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment | Pain during insertion of catheter |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Frank, PhD | Biologische Heilmittel Heel GmbH | +49 7221 501 3188 | christine.frank@heel.com |
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| ID | Term |
|---|---|
| D040701 | Stress Disorders, Traumatic, Acute |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C483503 | neurexan |
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| Changes in Saliva Cortisol | The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test. | -60 minutes, +15 minutes, +45 minutes, +100 minutes |
| Changes in Plasma Adrenocorticotropic Hormone (ACTH) | The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test. | -60 minutes, +15 minutes, +45 minutes, +100 minutes |
| Changes in Plasma Cortisol | The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test. | -60 minutes, +15 minutes, +45 minutes, +100 minutes |
| Changes in Plasma Catecholamines (Epinephrine) | The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test. | -60 minutes, +15 minutes, +45 minutes, +100 minutes |
| Changes in Plasma Catecholamines (Norepinephrine) | The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test. | -60 minutes, +15 minutes, +45 minutes, +100 minutes |
| Changes in Natural Killer (NK) Cells (Subgroup) | The Natural Killer Cells as immune cells and stress biomarkers were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test. | -60 minutes, +15 minutes, +45 minutes, +100 minutes |
| Changes in Blood Pressure | Blood pressure and heart rate were measured before and after a stress test by continuous cardiovascular recording. The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test. | -15 minutes, 0 minutes, +15 minutes, +45 minutes |
| Changes in Heart Rate | Blood pressure and heart rate were measured before and after a stress test by continuous cardiovascular recording. The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test. | -15 minutes, 0 minutes, +15 minutes, +45 minutes |
| State Anxiety and Stress Perception Measured by STAI-X1 | State anxiety and stress perception were measured by State-Trait Anxiety Inventory X1 before and after a stress test. The measurements took place 90 minutes before stress test and were repeated 15 and 100 minutes after the end of the stress test. The German version of the State-Trait-Anxiety Inventory was used and differentiates between temporary/emotional state anxiety versus personality trait anxiety. The two scales with 20 items each assess (1) anxiety as a trait (STAI-X2) and (2) anxiety as a state (STAI-XI). Answers are given in a 4-point rating scale ranging from 1 ="not at all" to 4 ="very true". For analysis of each, STAI-scale single scores were summed up to one total score, representing the state and trait anxiety. Score range is 20-80 and higher scores indicate a higher anxiety. | -90 minutes, +15 minutes, +100 minutes |
| Psychological Questionnaire (Modified Somatic SCL90) | The SCL90 has 90 items with dimensions like depression, somatization, obsessive-compulsive disorder, social insecurity, anxiety, phobic anxiety, aggression/hostility, paranoid ideation, psychoticism and each item in a subscale ranged from 0 to 4. The lower range values are favorable outcomes and higher are worse outcomes. The modified somatic SCL90 uses the SCL90 somatization items, but instead of a 7 day timeframe asks for "now". The corresponding items from SCL90 were: 1, 4, 12, 27, 40, 42, 48, 49, 52, 53, 56, 58 and the introductory question: "How much do you currently suffer from" ("Wie sehr leiden Sie momentan unter:"). The median of the average Modified Somatic SCL90 score is reported. The average score was calculated at each time point as the sum score divided by the number of non-missing individual question results for subjects with no more than 2 missing responses. The lower values in the range represent favorable outcomes while the higher values represent worse outcomes. | -210 minutes, +100 minutes |
| Klinische Psychologie und Psychotherapie, Fachbereich Psychologie, Universität Marburg |
| Marburg |
| 35032 |
| Germany |
| 8255414 | Background | Kirschbaum C, Pirke KM, Hellhammer DH. The 'Trier Social Stress Test'--a tool for investigating psychobiological stress responses in a laboratory setting. Neuropsychobiology. 1993;28(1-2):76-81. doi: 10.1159/000119004. |
| 21689890 | Background | Hellhammer J, Schubert M. The physiological response to Trier Social Stress Test relates to subjective measures of stress during but not before or after the test. Psychoneuroendocrinology. 2012 Jan;37(1):119-24. doi: 10.1016/j.psyneuen.2011.05.012. |
| 19837490 | Background | Schult J, Hero T, Hellhammer J. Effects of powdered fertilized eggs on the stress response. Clin Nutr. 2010 Apr;29(2):255-60. doi: 10.1016/j.clnu.2009.09.004. Epub 2009 Oct 17. |
| 4303377 | Background | Mason JW. A review of psychoendocrine research on the pituitary-adrenal cortical system. Psychosom Med. 1968 Sep-Oct;30(5):Suppl:576-607. No abstract available. |
| 5535207 | Background | Weiss JM. Somatic effects of predictable and unpredictable shock. Psychosom Med. 1970 Jul-Aug;32(4):397-408. doi: 10.1097/00006842-197007000-00008. No abstract available. |
| 10600217 | Background | Pawlak CR, Jacobs R, Mikeska E, Ochsmann S, Lombardi MS, Kavelaars A, Heijnen CJ, Schmidt RE, Schedlowski M. Patients with systemic lupus erythematosus differ from healthy controls in their immunological response to acute psychological stress. Brain Behav Immun. 1999 Dec;13(4):287-302. doi: 10.1006/brbi.1999.0553. |
| 8598500 | Background | Schedlowski M, Hosch W, Oberbeck R, Benschop RJ, Jacobs R, Raab HR, Schmidt RE. Catecholamines modulate human NK cell circulation and function via spleen-independent beta 2-adrenergic mechanisms. J Immunol. 1996 Jan 1;156(1):93-9. |
| 9491439 | Background | Schmid-Ott G, Jacobs R, Jager B, Klages S, Wolf J, Werfel T, Kapp A, Schurmeyer T, Lamprecht F, Schmidt RE, Schedlowski M. Stress-induced endocrine and immunological changes in psoriasis patients and healthy controls. A preliminary study. Psychother Psychosom. 1998;67(1):37-42. doi: 10.1159/000012257. |
At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Age, Categorical | 33 participants were randomized to Neurexan and 32 participants to Natural Course. All randomized participants were included in the Safety Set. One premature terminator could not be evaluated for primary efficacy, so 32 participants in the Neurexan group and 32 participants in the Natural Course group formed the Full Analysis Set for analysis of efficacy. | Count of Participants | Participants |
|
| Sex: Female, Male | 33 participants were randomized to Neurexan and 32 participants to Natural Course. All randomized participants were included in the Safety Set. One premature terminator could not be evaluated for primary efficacy, so 32 participants in the Neurexan group and 32 participants in the Natural Course group formed the Full Analysis Set for analysis of efficacy. | Count of Participants | Participants |
|
| Region of Enrollment | 33 participants were randomized to Neurexan and 32 participants to Natural Course. All randomized participants were included in the Safety Set. One premature terminator could not be evaluated for primary efficacy, so 32 participants in the Neurexan group and 32 participants in the Natural Course group formed the Full Analysis Set for analysis of efficacy. | Number | participants |
|
At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours. |
| OG001 | No Intervention | At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention. |
|
|
|
| Primary | Acute Stress Measured by Nervousness | Tension and nervousness were self-assessed by the participants on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) before and after a stress test. The VAS is used to determine the subjective impression of tension and nervousness on a 10 cm bipolar visual scale ranging from 0 = "not at all" to 100 = "highly". The measurements started with first intake of Neurexan or Natural Course and were repeated until 100 minutes after the end of the stress test. The total stress was then summarized with the Area under the curve (AUC) method. | 33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy. | Posted | Median | Full Range | mm*min | -210 minutes to +100 minutes |
|
|
|
|
| Secondary | Changes in Saliva Alpha Amylase | The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test. | 33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for efficacy. Note: -60 minute time-point had 31 evaluable Neurexan participants. | Posted | Median | Full Range | IU/mL | -60 minute, +15 minute , + 45 minute, +100 minute |
|
|
|
| Secondary | Changes in Saliva Cortisol | The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test. | 33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy. | Posted | Median | Full Range | nmol/mL | -60 minutes, +15 minutes, +45 minutes, +100 minutes |
|
|
|
| Secondary | Changes in Plasma Adrenocorticotropic Hormone (ACTH) | The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test. | 33 participants were randomized to Neurexan and 32 to Natural Course and all randomized participants were included in the Safety Set. For plasma ACTH evaluation 31 Neurexan and 24 Natural Course participants were evaluated due to insufficient samples and the -60 min time-point had 30 evaluable Neurexan participants. | Posted | Median | Full Range | ng/L | -60 minutes, +15 minutes, +45 minutes, +100 minutes |
|
|
|
| Secondary | Changes in Plasma Cortisol | The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test. | 33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. For the plasma Cortisol evaluation 31 Neurexan and 24 Natural Course participants were evaluated due to insufficient sample. | Posted | Median | Full Range | nmol/L | -60 minutes, +15 minutes, +45 minutes, +100 minutes |
|
|
|
| Secondary | Changes in Plasma Catecholamines (Epinephrine) | The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test. | 33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. For plasma Epinephrine evaluation 30 Neurexan and 23 Natural Course participants were evaluated due to insufficient sample. | Posted | Median | Full Range | ng/L | -60 minutes, +15 minutes, +45 minutes, +100 minutes |
|
|
|
| Secondary | Changes in Plasma Catecholamines (Norepinephrine) | The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test. | 33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. For plasma Norepinephrine evaluation 30 Neurexan and 23 Natural Course participants were evaluated due to insufficient sample. | Posted | Median | Full Range | ng/L | -60 minutes, +15 minutes, +45 minutes, +100 minutes |
|
|
|
| Secondary | Changes in Natural Killer (NK) Cells (Subgroup) | The Natural Killer Cells as immune cells and stress biomarkers were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test. | The test was only conducted in the Essen site where 15 participants randomized to Neurexan and 12 participants randomized to Natural Course could be evaluated for NK cells | Posted | Median | Full Range | percentage of lymphocytes | -60 minutes, +15 minutes, +45 minutes, +100 minutes |
|
|
|
| Secondary | Changes in Blood Pressure | Blood pressure and heart rate were measured before and after a stress test by continuous cardiovascular recording. The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test. | 33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy. | Posted | Median | Full Range | mmHg | -15 minutes, 0 minutes, +15 minutes, +45 minutes |
|
|
|
| Secondary | Changes in Heart Rate | Blood pressure and heart rate were measured before and after a stress test by continuous cardiovascular recording. The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test. | 33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy. | Posted | Median | Full Range | beats per minute | -15 minutes, 0 minutes, +15 minutes, +45 minutes |
|
|
|
| Secondary | State Anxiety and Stress Perception Measured by STAI-X1 | State anxiety and stress perception were measured by State-Trait Anxiety Inventory X1 before and after a stress test. The measurements took place 90 minutes before stress test and were repeated 15 and 100 minutes after the end of the stress test. The German version of the State-Trait-Anxiety Inventory was used and differentiates between temporary/emotional state anxiety versus personality trait anxiety. The two scales with 20 items each assess (1) anxiety as a trait (STAI-X2) and (2) anxiety as a state (STAI-XI). Answers are given in a 4-point rating scale ranging from 1 ="not at all" to 4 ="very true". For analysis of each, STAI-scale single scores were summed up to one total score, representing the state and trait anxiety. Score range is 20-80 and higher scores indicate a higher anxiety. | 33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy. | Posted | Median | Full Range | units on a scale | -90 minutes, +15 minutes, +100 minutes |
|
|
|
| Secondary | Psychological Questionnaire (Modified Somatic SCL90) | The SCL90 has 90 items with dimensions like depression, somatization, obsessive-compulsive disorder, social insecurity, anxiety, phobic anxiety, aggression/hostility, paranoid ideation, psychoticism and each item in a subscale ranged from 0 to 4. The lower range values are favorable outcomes and higher are worse outcomes. The modified somatic SCL90 uses the SCL90 somatization items, but instead of a 7 day timeframe asks for "now". The corresponding items from SCL90 were: 1, 4, 12, 27, 40, 42, 48, 49, 52, 53, 56, 58 and the introductory question: "How much do you currently suffer from" ("Wie sehr leiden Sie momentan unter:"). The median of the average Modified Somatic SCL90 score is reported. The average score was calculated at each time point as the sum score divided by the number of non-missing individual question results for subjects with no more than 2 missing responses. The lower values in the range represent favorable outcomes while the higher values represent worse outcomes. | 33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy. | Posted | Median | Full Range | units on a scale | -210 minutes, +100 minutes |
|
|
|
| 0 |
| 33 |
| 4 |
| 33 |
| EG001 | No Intervention | At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention. | 0 | 32 | 3 | 32 |
|
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment | Dizziness as result from blood catheter insertion |
|
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment | Nausea during insertion of catheter |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (15.1) | Systematic Assessment | Increased transaminases (GOT) |
|
| Alanine aminotransferase increased | Investigations | MedDRA (15.1) | Systematic Assessment | increase in transaminases (GPT) |
|
| Dizziness | Nervous system disorders | MedDRA (15.1) | Systematic Assessment | Dizziness |
|
| Headache | Nervous system disorders | MedDRA (15.1) | Systematic Assessment | Mild Headache |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment | Dry Mouth |
|
Investigator agreements in place restricting the PI from independently publishing the study results. Currently working with both PIs on several publications of the NEUPRO studies.
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| +45 min |
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| +100 min |
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| Systolic blood pressure +15 min |
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| Systolic blood pressure +45 min |
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| Diastolic blood pressure -15 min |
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| Diastolic blood pressure 0 min |
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| Diastolic blood pressure +15 min |
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| Diastolic blood pressure +45 min |
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| +15 min |
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| +45 min |
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| +100 min |
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