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Explorative Efficacy Profile of Neurexan® in an Experimental Acute Stress Setting in Healthy Subjects (NEUPRO-DB)

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ClinicalTrials.gov Identifier: NCT01703819
Recruitment Status : Completed
First Posted : October 11, 2012
Results First Posted : February 11, 2015
Last Update Posted : February 11, 2015
Sponsor:
Information provided by (Responsible Party):
Biologische Heilmittel Heel GmbH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acute Stress Reaction
Interventions Drug: Neurexan®
Other: Placebo
Enrollment 66
Recruitment Details Recruitment was carried out in 2 outpatient clinics in Germany (Marburg and Essen).
Pre-assignment Details All 66 healthy participants were enrolled and none of them was excluded prior to randomization.
Arm/Group Title Neurexan® Placebo
Hide Arm/Group Description

0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Neurexan®

6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Placebo

Period Title: Overall Study
Started 34 32
Completed 34 30
Not Completed 0 2
Reason Not Completed
Adverse Event             0             1
Withdrawal by Subject             0             1
Arm/Group Title Neurexan® Placebo Total
Hide Arm/Group Description

0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to

-30 minutes

Neurexan®

6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 34 32 66
Hide Baseline Analysis Population Description
34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. Two premature terminators could not be evaluated for primary efficacy, so 34 participants in the Neurexan group and 30 participants in the Placebo group formed the Full Analysis Set for analysis of efficacy.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 32 participants 66 participants
41.1  (7.0) 40.7  (8.2) 40.9  (7.6)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 32 participants 66 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
34
 100.0%
32
 100.0%
66
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 32 participants 66 participants
Female
18
  52.9%
16
  50.0%
34
  51.5%
Male
16
  47.1%
16
  50.0%
32
  48.5%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 34 participants 32 participants 66 participants
34 32 66
[1]
Measure Description: 34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. Two premature terminators could not be evaluated for primary efficacy, so 34 participants in the Neurexan group and 30 participants in the Placebo group formed the Full Analysis Set for analysis of efficacy.
1.Primary Outcome
Title Acute Stress Measured by Tension
Hide Description

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.

Time Frame -210 minutes to +100 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Neurexan® Placebo
Hide Arm/Group Description:

0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Neurexan®

6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Placebo

Overall Number of Participants Analyzed 34 30
Median (Full Range)
Unit of Measure: mm*min
3335.7
(345 to 16411)
3360.3
(0 to 21115)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Neurexan®, Placebo
Comments The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOVAs.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7726
Comments Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Acute Stress Measured by Nervousness
Hide Description

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.

Time Frame -210 minutes to +100 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Neurexan® Placebo
Hide Arm/Group Description:

0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Neurexan®

6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Placebo

Overall Number of Participants Analyzed 34 30
Median (Full Range)
Unit of Measure: mm*min
3147.4
(247 to 17050)
3022.5
(0 to 21409)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Neurexan®, Placebo
Comments The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOV As.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5702
Comments Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Changes in Saliva Alpha Amylase
Hide Description 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.
Time Frame -60 minutes, +15 minutes, +45 minutes, +100 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Neurexan® Placebo
Hide Arm/Group Description:

0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Neurexan®

6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Placebo

Overall Number of Participants Analyzed 34 30
Median (Full Range)
Unit of Measure: IU/mL
- 60 min
112.9
(19.7 to 353.7)
133.3
(23.7 to 421.1)
+15 min
201.9
(78.4 to 729.7)
216.0
(49.3 to 670.9)
+45 min
140.8
(25.6 to 420.4)
142.1
(37.1 to 484.8)
+100 min
149.9
(29.2 to 465.1)
140.6
(35.1 to 417.3)
4.Secondary Outcome
Title Changes in Saliva Cortisol
Hide Description 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.
Time Frame -60 minutes, +15 minutes, +45 minutes, +100 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Neurexan® Placebo
Hide Arm/Group Description:

0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Neurexan®

6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Placebo

Overall Number of Participants Analyzed 34 30
Median (Full Range)
Unit of Measure: nmol/mL
- 60 min
7.1
(3.0 to 17.4)
7.1
(2.7 to 32.4)
+15 min
19.4
(7.2 to 120.8)
20.0
(6.1 to 86.6)
+45 min
15.3
(7.0 to 80.7)
21.2
(3.9 to 81.4)
+100 min
6.4
(3.7 to 20.9)
8.9
(3.6 to 21.2)
5.Secondary Outcome
Title Changes in Plasma Adrenocorticotropic Hormone (ACTH)
Hide Description 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.
Time Frame -60 minutes, +15 minutes, +45 minutes, +100 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Neurexan® Placebo
Hide Arm/Group Description:

0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Neurexan®

6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Placebo

Overall Number of Participants Analyzed 31 29
Median (Full Range)
Unit of Measure: ng/L
- 60 min
22.5
(9.2 to 330.4)
19.1
(5.5 to 493.2)
+15 min
37.7
(13.9 to 124.2)
37.0
(13.6 to 209.7)
+45 min
20.3
(7.5 to 42.3)
20.7
(7.5 to 79.4)
+100 min
11.3
(3.2 to 24.4)
10.7
(5.4 to 24.0)
6.Secondary Outcome
Title Changes in Plasma Cortisol
Hide Description 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.
Time Frame -60 minutes, +15 minutes, +45 minutes, +100 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Neurexan® Placebo
Hide Arm/Group Description:

0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Neurexan®

6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Placebo

Overall Number of Participants Analyzed 31 29
Median (Full Range)
Unit of Measure: nmol/L
- 60 min
331.6
(97.6 to 614.8)
325.5
(54.2 to 1006.7)
+15 min
441.1
(281.4 to 987.1)
569.8
(174.1 to 1048.7)
+45 min
403.1
(223.7 to 1260)
535.4
(142.5 to 841.2)
+100 min
228.4
(94.6 to 671.8)
273.3
(108.5 to 658.0)
7.Secondary Outcome
Title Changes in Plasma Catecholamines (Epinephrine)
Hide Description 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.
Time Frame -60 minutes, +15 minutes, +45 minutes, +100 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Neurexan® Placebo
Hide Arm/Group Description:

0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Neurexan®

6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Placebo

Overall Number of Participants Analyzed 30 26
Median (Full Range)
Unit of Measure: ng/L
- 60 min
42.6
(10.0 to 98.0)
35.6
(8.1 to 146.0)
+15 min
32.9
(10.0 to 116.0)
47.4
(10.0 to 126.0)
+45 min
41.4
(10.0 to 152.0)
26.4
(10.0 to 101.0)
+100 min
31.9
(0.0 to 91.3)
41.1
(11.3 to 89.9)
8.Secondary Outcome
Title Changes in Plasma Catecholamines (Norepinephrine)
Hide Description 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.
Time Frame -60 minutes, +15 minutes, +45 minutes, +100 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Neurexan® Placebo
Hide Arm/Group Description:

0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Neurexan®

6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Placebo

Overall Number of Participants Analyzed 30 26
Median (Full Range)
Unit of Measure: ng/L
- 60 min
463.0
(99 to 990)
457.0
(253 to 1329)
+15 min
584.0
(150 to 1352)
591.5
(316 to 1856)
+45 min
481.0
(231 to 1530)
476.0
(168 to 1189)
+100 min
451.5
(215 to 1318)
482.5
(230 to 815)
9.Secondary Outcome
Title Changes in Natural Killer (NK) Cells (Subgroup)
Hide Description 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.
Time Frame -60 minutes, +15 minutes, +45 minutes, +100 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Neurexan® Placebo
Hide Arm/Group Description:

0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Neurexan®

6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Placebo

Overall Number of Participants Analyzed 15 16
Median (Full Range)
Unit of Measure: percentage of lymphocytes
- 60 min
13.5
(5.5 to 23.2)
11.65
(6.3 to 21.0)
+15 min
21.00
(9.1 to 36.2)
20.40
(8.0 to 37.3)
+45 min
10.30
(3.3 to 20.4)
9.10
(5.4 to 18.6)
+100 min
13.10
(4.3 to 20.9)
8.65
(5.5 to 21.5)
10.Secondary Outcome
Title Changes in Blood Pressure
Hide Description

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.

Time Frame -15 minutes, 0 minutes, +15 minutes, +45 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Neurexan® Placebo
Hide Arm/Group Description:

0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Neurexan®

6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Placebo

Overall Number of Participants Analyzed 34 30
Median (Full Range)
Unit of Measure: mmHg
Systolic -15 min
122.0
(96 to 153)
123.5
(102 to 147)
Systolic 0 min
132.0
(106 to 201)
142.0
(110 to 168)
Systolic +15 min
125.0
(99 to 164)
133.5
(105 to 153)
Systolic +45 min
121.5
(96 to 163)
125.0
(101 to 182)
Diastolic - 15 min
79.5
(58 to 109)
81.5
(61 to 98)
Diastolic 0 min
81.0
(66 to 117)
91.0
(63 to 107)
Diastolic +15 min
83.5
(65 to 115)
89.0
(63 to 109)
Diastolic +45 min
81.0
(34 to 113)
83.0
(63 to 113)
11.Secondary Outcome
Title Changes in Heart Rate
Hide Description

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.

Time Frame -15 minutes, 0 minutes, +15 minutes, +45 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Neurexan® Placebo
Hide Arm/Group Description:

0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Neurexan®

6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Placebo

Overall Number of Participants Analyzed 34 30
Median (Full Range)
Unit of Measure: beats per minute
-15 min
70.0
(55 to 96)
69.0
(52 to 94)
0 min
88.0
(65 to 115)
89.5
(65 to 131)
+15 min
69.5
(56 to 94)
71.0
(53 to 119)
+45 min
71.0
(59 to 106)
71.0
(55 to 91)
12.Secondary Outcome
Title State Anxiety and Stress Perception Measured by STAI-X1
Hide Description 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.
Time Frame -90 minutes, +15 minutes, +100 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Neurexan® Placebo
Hide Arm/Group Description:

0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Neurexan®

6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Placebo

Overall Number of Participants Analyzed 34 30
Median (Full Range)
Unit of Measure: units on a scale
- 90 min
31.0
(21 to 45)
29.5
(22 to 50)
+15 min
54.5
(24 to 74)
51.5
(23 to 68)
+100 min
33.0
(20 to 69)
31.5
(22 to 48)
13.Secondary Outcome
Title Psychological Questionnaire (Modified Somatic SCL90)
Hide Description 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.
Time Frame -210 minutes, +100 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Neurexan® Placebo
Hide Arm/Group Description:

0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Neurexan®

6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Placebo

Overall Number of Participants Analyzed 34 30
Median (Full Range)
Unit of Measure: units on a scale
- 210 min
0.000
(0.00 to 0.83)
0.000
(0.00 to 0.42)
+100 min
0.000
(0.00 to 0.75)
0.000
(0.00 to 0.33)
Time Frame Randomization until individual study end
Adverse Event Reporting Description 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
 
Arm/Group Title Neurexan® Placebo
Hide Arm/Group Description

0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Neurexan®

6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Placebo

All-Cause Mortality
Neurexan® Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Neurexan® Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/32 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Neurexan® Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   4/34 (11.76%)   3/32 (9.38%) 
Gastrointestinal disorders     
Nausea  1  1/34 (2.94%)  0/32 (0.00%) 
General disorders     
Feeling Cold  1  1/34 (2.94%)  0/32 (0.00%) 
Fatigue  1  0/34 (0.00%)  1/32 (3.13%) 
Investigations     
Blood Pressure Decrease  1  0/34 (0.00%)  2/32 (6.25%) 
Nervous system disorders     
Tremor  1  0/34 (0.00%)  1/32 (3.13%) 
Procedural dizziness  1  1/34 (2.94%)  0/32 (0.00%) 
Headache  1  2/34 (5.88%)  0/32 (0.00%) 
Dizziness  1  1/34 (2.94%)  1/32 (3.13%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  0/34 (0.00%)  1/32 (3.13%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Christine Frank, PhD
Organization: Biologische Heilmittel Heel GmbH
Phone: +49 7221 501 3188
Publications:
Responsible Party: Biologische Heilmittel Heel GmbH
ClinicalTrials.gov Identifier: NCT01703819     History of Changes
Other Study ID Numbers: C1201
2012-002358-22 ( EudraCT Number )
First Submitted: October 8, 2012
First Posted: October 11, 2012
Results First Submitted: August 1, 2014
Results First Posted: February 11, 2015
Last Update Posted: February 11, 2015