Trial Outcomes & Findings for Explorative Efficacy Profile of Neurexan® in an Experimental Acute Stress Setting in Healthy Subjects (NCT NCT01703819)
NCT ID: NCT01703819
Last Updated: 2015-02-11
Results Overview
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 Placebo 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.
COMPLETED
PHASE1/PHASE2
66 participants
-210 minutes to +100 minutes
2015-02-11
Participant Flow
Recruitment was carried out in 2 outpatient clinics in Germany (Marburg and Essen).
All 66 healthy participants were enrolled and none of them was excluded prior to randomization.
Participant milestones
| Measure |
Neurexan®
0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®
|
Placebo
6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
32
|
|
Overall Study
COMPLETED
|
34
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Neurexan®
0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®
|
Placebo
6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Explorative Efficacy Profile of Neurexan® in an Experimental Acute Stress Setting in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Neurexan®
n=34 Participants
0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to
-30 minutes
Neurexan®
|
Placebo
n=32 Participants
6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.1 Years
STANDARD_DEVIATION 7.0 • n=113 Participants
|
40.7 Years
STANDARD_DEVIATION 8.2 • n=163 Participants
|
40.9 Years
STANDARD_DEVIATION 7.6 • n=160 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=113 Participants
|
32 Participants
n=163 Participants
|
66 Participants
n=160 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=113 Participants
|
16 Participants
n=163 Participants
|
34 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=113 Participants
|
16 Participants
n=163 Participants
|
32 Participants
n=160 Participants
|
|
Region of Enrollment
Germany
|
34 participants
n=113 Participants
|
32 participants
n=163 Participants
|
66 participants
n=160 Participants
|
PRIMARY outcome
Timeframe: -210 minutes to +100 minutesPopulation: 34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.
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 Placebo 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.
Outcome measures
| Measure |
Neurexan®
n=34 Participants
0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®
|
Placebo
n=30 Participants
6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo
|
|---|---|---|
|
Acute Stress Measured by Tension
|
3335.7 mm*min
Interval 345.0 to 16411.0
|
3360.3 mm*min
Interval 0.0 to 21115.0
|
PRIMARY outcome
Timeframe: -210 minutes to +100 minutesPopulation: 34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.
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 Placebo 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.
Outcome measures
| Measure |
Neurexan®
n=34 Participants
0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®
|
Placebo
n=30 Participants
6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo
|
|---|---|---|
|
Acute Stress Measured by Nervousness
|
3147.4 mm*min
Interval 247.0 to 17050.0
|
3022.5 mm*min
Interval 0.0 to 21409.0
|
SECONDARY outcome
Timeframe: -60 minutes, +15 minutes, +45 minutes, +100 minutesPopulation: 34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.
The stress biomarkers plasma and saliva cortisol, alpha amylase, 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.
Outcome measures
| Measure |
Neurexan®
n=34 Participants
0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®
|
Placebo
n=30 Participants
6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo
|
|---|---|---|
|
Changes in Saliva Alpha Amylase
+100 min
|
149.9 IU/mL
Interval 29.2 to 465.1
|
140.6 IU/mL
Interval 35.1 to 417.3
|
|
Changes in Saliva Alpha Amylase
- 60 min
|
112.9 IU/mL
Interval 19.7 to 353.7
|
133.3 IU/mL
Interval 23.7 to 421.1
|
|
Changes in Saliva Alpha Amylase
+15 min
|
201.9 IU/mL
Interval 78.4 to 729.7
|
216.0 IU/mL
Interval 49.3 to 670.9
|
|
Changes in Saliva Alpha Amylase
+45 min
|
140.8 IU/mL
Interval 25.6 to 420.4
|
142.1 IU/mL
Interval 37.1 to 484.8
|
SECONDARY outcome
Timeframe: -60 minutes, +15 minutes, +45 minutes, +100 minutesPopulation: 34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.
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.
Outcome measures
| Measure |
Neurexan®
n=34 Participants
0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®
|
Placebo
n=30 Participants
6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo
|
|---|---|---|
|
Changes in Saliva Cortisol
- 60 min
|
7.1 nmol/mL
Interval 3.0 to 17.4
|
7.1 nmol/mL
Interval 2.7 to 32.4
|
|
Changes in Saliva Cortisol
+15 min
|
19.4 nmol/mL
Interval 7.2 to 120.8
|
20.0 nmol/mL
Interval 6.1 to 86.6
|
|
Changes in Saliva Cortisol
+45 min
|
15.3 nmol/mL
Interval 7.0 to 80.7
|
21.2 nmol/mL
Interval 3.9 to 81.4
|
|
Changes in Saliva Cortisol
+100 min
|
6.4 nmol/mL
Interval 3.7 to 20.9
|
8.9 nmol/mL
Interval 3.6 to 21.2
|
SECONDARY outcome
Timeframe: -60 minutes, +15 minutes, +45 minutes, +100 minutesPopulation: 34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. For evaluation of plasma ACTH, 31 Neurexan and 29 Placebo participants were evaluated due to insufficient sample.
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.
Outcome measures
| Measure |
Neurexan®
n=31 Participants
0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®
|
Placebo
n=29 Participants
6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo
|
|---|---|---|
|
Changes in Plasma Adrenocorticotropic Hormone (ACTH)
+45 min
|
20.3 ng/L
Interval 7.5 to 42.3
|
20.7 ng/L
Interval 7.5 to 79.4
|
|
Changes in Plasma Adrenocorticotropic Hormone (ACTH)
+100 min
|
11.3 ng/L
Interval 3.2 to 24.4
|
10.7 ng/L
Interval 5.4 to 24.0
|
|
Changes in Plasma Adrenocorticotropic Hormone (ACTH)
- 60 min
|
22.5 ng/L
Interval 9.2 to 330.4
|
19.1 ng/L
Interval 5.5 to 493.2
|
|
Changes in Plasma Adrenocorticotropic Hormone (ACTH)
+15 min
|
37.7 ng/L
Interval 13.9 to 124.2
|
37.0 ng/L
Interval 13.6 to 209.7
|
SECONDARY outcome
Timeframe: -60 minutes, +15 minutes, +45 minutes, +100 minutesPopulation: 34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. For evaluation of plasma Cortisol, 31 Neurexan and 29 Placebo participants were evaluated due to insufficient sample.
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.
Outcome measures
| Measure |
Neurexan®
n=31 Participants
0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®
|
Placebo
n=29 Participants
6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo
|
|---|---|---|
|
Changes in Plasma Cortisol
+100 min
|
228.4 nmol/L
Interval 94.6 to 671.8
|
273.3 nmol/L
Interval 108.5 to 658.0
|
|
Changes in Plasma Cortisol
- 60 min
|
331.6 nmol/L
Interval 97.6 to 614.8
|
325.5 nmol/L
Interval 54.2 to 1006.7
|
|
Changes in Plasma Cortisol
+15 min
|
441.1 nmol/L
Interval 281.4 to 987.1
|
569.8 nmol/L
Interval 174.1 to 1048.7
|
|
Changes in Plasma Cortisol
+45 min
|
403.1 nmol/L
Interval 223.7 to 1260.0
|
535.4 nmol/L
Interval 142.5 to 841.2
|
SECONDARY outcome
Timeframe: -60 minutes, +15 minutes, +45 minutes, +100 minutesPopulation: 34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. For evaluation of plasma Epinephrine, 30 Neurexan and 26 Placebo participants were evaluated due to insufficient sample.
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.
Outcome measures
| Measure |
Neurexan®
n=30 Participants
0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®
|
Placebo
n=26 Participants
6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo
|
|---|---|---|
|
Changes in Plasma Catecholamines (Epinephrine)
- 60 min
|
42.6 ng/L
Interval 10.0 to 98.0
|
35.6 ng/L
Interval 8.1 to 146.0
|
|
Changes in Plasma Catecholamines (Epinephrine)
+45 min
|
41.4 ng/L
Interval 10.0 to 152.0
|
26.4 ng/L
Interval 10.0 to 101.0
|
|
Changes in Plasma Catecholamines (Epinephrine)
+100 min
|
31.9 ng/L
Interval 0.0 to 91.3
|
41.1 ng/L
Interval 11.3 to 89.9
|
|
Changes in Plasma Catecholamines (Epinephrine)
+15 min
|
32.9 ng/L
Interval 10.0 to 116.0
|
47.4 ng/L
Interval 10.0 to 126.0
|
SECONDARY outcome
Timeframe: -60 minutes, +15 minutes, +45 minutes, +100 minutesPopulation: 34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. For evaluation of plasma Norepinephrine, 30 Neurexan and 26 Placebo participants were evaluated due to insufficient sample.
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.
Outcome measures
| Measure |
Neurexan®
n=30 Participants
0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®
|
Placebo
n=26 Participants
6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo
|
|---|---|---|
|
Changes in Plasma Catecholamines (Norepinephrine)
- 60 min
|
463.0 ng/L
Interval 99.0 to 990.0
|
457.0 ng/L
Interval 253.0 to 1329.0
|
|
Changes in Plasma Catecholamines (Norepinephrine)
+15 min
|
584.0 ng/L
Interval 150.0 to 1352.0
|
591.5 ng/L
Interval 316.0 to 1856.0
|
|
Changes in Plasma Catecholamines (Norepinephrine)
+45 min
|
481.0 ng/L
Interval 231.0 to 1530.0
|
476.0 ng/L
Interval 168.0 to 1189.0
|
|
Changes in Plasma Catecholamines (Norepinephrine)
+100 min
|
451.5 ng/L
Interval 215.0 to 1318.0
|
482.5 ng/L
Interval 230.0 to 815.0
|
SECONDARY outcome
Timeframe: -60 minutes, +15 minutes, +45 minutes, +100 minutesPopulation: The test was only conducted in the Essen site where 15 participants randomized to Neurexan and 16 participants randomized to Placebo could be evaluated for NK cells.
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.
Outcome measures
| Measure |
Neurexan®
n=15 Participants
0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®
|
Placebo
n=16 Participants
6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo
|
|---|---|---|
|
Changes in Natural Killer (NK) Cells (Subgroup)
- 60 min
|
13.5 percentage of lymphocytes
Interval 5.5 to 23.2
|
11.65 percentage of lymphocytes
Interval 6.3 to 21.0
|
|
Changes in Natural Killer (NK) Cells (Subgroup)
+15 min
|
21.00 percentage of lymphocytes
Interval 9.1 to 36.2
|
20.40 percentage of lymphocytes
Interval 8.0 to 37.3
|
|
Changes in Natural Killer (NK) Cells (Subgroup)
+45 min
|
10.30 percentage of lymphocytes
Interval 3.3 to 20.4
|
9.10 percentage of lymphocytes
Interval 5.4 to 18.6
|
|
Changes in Natural Killer (NK) Cells (Subgroup)
+100 min
|
13.10 percentage of lymphocytes
Interval 4.3 to 20.9
|
8.65 percentage of lymphocytes
Interval 5.5 to 21.5
|
SECONDARY outcome
Timeframe: -15 minutes, 0 minutes, +15 minutes, +45 minutesPopulation: 34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.
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.
Outcome measures
| Measure |
Neurexan®
n=34 Participants
0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®
|
Placebo
n=30 Participants
6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo
|
|---|---|---|
|
Changes in Blood Pressure
Systolic +15 min
|
125.0 mmHg
Interval 99.0 to 164.0
|
133.5 mmHg
Interval 105.0 to 153.0
|
|
Changes in Blood Pressure
Systolic +45 min
|
121.5 mmHg
Interval 96.0 to 163.0
|
125.0 mmHg
Interval 101.0 to 182.0
|
|
Changes in Blood Pressure
Diastolic - 15 min
|
79.5 mmHg
Interval 58.0 to 109.0
|
81.5 mmHg
Interval 61.0 to 98.0
|
|
Changes in Blood Pressure
Diastolic +15 min
|
83.5 mmHg
Interval 65.0 to 115.0
|
89.0 mmHg
Interval 63.0 to 109.0
|
|
Changes in Blood Pressure
Systolic -15 min
|
122.0 mmHg
Interval 96.0 to 153.0
|
123.5 mmHg
Interval 102.0 to 147.0
|
|
Changes in Blood Pressure
Systolic 0 min
|
132.0 mmHg
Interval 106.0 to 201.0
|
142.0 mmHg
Interval 110.0 to 168.0
|
|
Changes in Blood Pressure
Diastolic 0 min
|
81.0 mmHg
Interval 66.0 to 117.0
|
91.0 mmHg
Interval 63.0 to 107.0
|
|
Changes in Blood Pressure
Diastolic +45 min
|
81.0 mmHg
Interval 34.0 to 113.0
|
83.0 mmHg
Interval 63.0 to 113.0
|
SECONDARY outcome
Timeframe: -15 minutes, 0 minutes, +15 minutes, +45 minutesPopulation: 34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.
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.
Outcome measures
| Measure |
Neurexan®
n=34 Participants
0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®
|
Placebo
n=30 Participants
6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo
|
|---|---|---|
|
Changes in Heart Rate
0 min
|
88.0 beats per minute
Interval 65.0 to 115.0
|
89.5 beats per minute
Interval 65.0 to 131.0
|
|
Changes in Heart Rate
+15 min
|
69.5 beats per minute
Interval 56.0 to 94.0
|
71.0 beats per minute
Interval 53.0 to 119.0
|
|
Changes in Heart Rate
+45 min
|
71.0 beats per minute
Interval 59.0 to 106.0
|
71.0 beats per minute
Interval 55.0 to 91.0
|
|
Changes in Heart Rate
-15 min
|
70.0 beats per minute
Interval 55.0 to 96.0
|
69.0 beats per minute
Interval 52.0 to 94.0
|
SECONDARY outcome
Timeframe: -90 minutes, +15 minutes, +100 minutesPopulation: 34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.
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 the stress test and were repeated at 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.
Outcome measures
| Measure |
Neurexan®
n=34 Participants
0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®
|
Placebo
n=30 Participants
6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo
|
|---|---|---|
|
State Anxiety and Stress Perception Measured by STAI-X1
- 90 min
|
31.0 units on a scale
Interval 21.0 to 45.0
|
29.5 units on a scale
Interval 22.0 to 50.0
|
|
State Anxiety and Stress Perception Measured by STAI-X1
+15 min
|
54.5 units on a scale
Interval 24.0 to 74.0
|
51.5 units on a scale
Interval 23.0 to 68.0
|
|
State Anxiety and Stress Perception Measured by STAI-X1
+100 min
|
33.0 units on a scale
Interval 20.0 to 69.0
|
31.5 units on a scale
Interval 22.0 to 48.0
|
SECONDARY outcome
Timeframe: -210 minutes, +100 minutesPopulation: 34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.
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.
Outcome measures
| Measure |
Neurexan®
n=34 Participants
0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®
|
Placebo
n=30 Participants
6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo
|
|---|---|---|
|
Psychological Questionnaire (Modified Somatic SCL90)
- 210 min
|
0.000 units on a scale
Interval 0.0 to 0.83
|
0.000 units on a scale
Interval 0.0 to 0.42
|
|
Psychological Questionnaire (Modified Somatic SCL90)
+100 min
|
0.000 units on a scale
Interval 0.0 to 0.75
|
0.000 units on a scale
Interval 0.0 to 0.33
|
Adverse Events
Neurexan®
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Neurexan®
n=34 participants at risk
0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Neurexan®
|
Placebo
n=32 participants at risk
6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Placebo
|
|---|---|---|
|
Nervous system disorders
Tremor
|
0.00%
0/34 • 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
|
3.1%
1/32 • 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
|
|
General disorders
Feeling Cold
|
2.9%
1/34 • 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
|
0.00%
0/32 • 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
|
|
General disorders
Fatigue
|
0.00%
0/34 • 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
|
3.1%
1/32 • 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
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/34 • 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
|
3.1%
1/32 • 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
|
|
Nervous system disorders
Procedural dizziness
|
2.9%
1/34 • 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
|
0.00%
0/32 • 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
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/34 • 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
|
0.00%
0/32 • 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
|
|
Nervous system disorders
Headache
|
5.9%
2/34 • 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
|
0.00%
0/32 • 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
|
|
Nervous system disorders
Dizziness
|
2.9%
1/34 • 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
|
3.1%
1/32 • 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
|
|
Investigations
Blood Pressure Decrease
|
0.00%
0/34 • 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
|
6.2%
2/32 • 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
|
Additional Information
Christine Frank, PhD
Biologische Heilmittel Heel GmbH
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator agreements are in place restricting the PI from independently publishing the study results. Currently working with both PIs on several publications of the NEUPRO studies.
- Publication restrictions are in place
Restriction type: OTHER