Phase 2 N=65 Randomized Treatment

Explorative Open Label Study of Efficacy Profile of Neurexan® in Experimental Acute Stress Setting in Healthy Subjects

Acute Stress Reaction

Bottom Line

View on ClinicalTrials.gov: NCT01703832 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2015

Primary outcome: Primary: Acute Stress Measured by Tension — 3089.4; 3253.4 mm*min — p=0.1233

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Neurexan® (Drug)
Age: Adult · 31+ yrs
Sex: All
Sponsor: Biologische Heilmittel Heel GmbH
Primary completion: Apr 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Acute Stress Measured by Tension	3089.4; 3253.4	0.1233
PRIMARY Acute Stress Measured by Nervousness	2377.3; 3426.8	0.5153
SECONDARY Changes in Saliva Alpha Amylase	155.6; 133.2; 242.8; 204.9; 171.3; 138.6	—
SECONDARY Changes in Saliva Cortisol	7.9; 8.1; 20.3; 19.8; 18.8; 20.6	—
SECONDARY Changes in Plasma Adrenocorticotropic Hormone (ACTH)	20.8; 20.0; 35.4; 31.0; 20.4; 20.6	—
SECONDARY Changes in Plasma Cortisol	365.9; 337.6; 554.3; 544.3; 466.8; 506.8	—
SECONDARY Changes in Plasma Catecholamines (Epinephrine)	44.6; 37.0; 58.2; 40.2; 37.3; 32.0	—
SECONDARY Changes in Plasma Catecholamines (Norepinephrine)	484.5; 457.0; 575.5; 529.0; 458.0; 459.0	—
SECONDARY Changes in Natural Killer (NK) Cells (Subgroup)	11.8; 11.2; 21.3; 17.7; 11.6; 8.6	—
SECONDARY Changes in Blood Pressure	120.5; 123.5; 131.0; 136.5; 123.0; 128.5	—
SECONDARY Changes in Heart Rate	67.0; 69.0; 87.0; 83.0; 68.0; 71.0	—
SECONDARY State Anxiety and Stress Perception Measured by STAI-X1	32.0; 33.0; 51.0; 56.0; 32.0; 32.0	—
SECONDARY Psychological Questionnaire (Modified Somatic SCL90)	0.042; 0.083; 0.000; 0.000	—

Summary

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

Eligibility Criteria

Inclusion Criteria

Provide written informed consent
Healthy male or female
age between 31 to 59 years
Fluent in German language.
Ability to understand the explanations and instructions given by the study physician

Exclusion Criteria

allergies to ingredients of Neurexan® (Passiflora incarnata, Avena sativa, Coffea arabica, Zincum isovalerianicum, lactose monohydrate, magnesium stearate)
lactose intolerance
use of any psychological stress-management intervention within the last 4 weeks
sick leave for any reason
participation in any other clinical study 3 months prior to Screening Visit
current or recent (3 months prior to Screening Visit) history of substance abuse or drug dependence including nicotine and alcohol (as verified in the respective IDCL list)
smokers
alcohol intake within last 24 hours (before Baseline Visit V3)
shift workers or work regularly during night time
use of any psychotropic medication or suffering from severe psychiatric illness needing acute intervention
BMI > 30 kg/m2
currently pregnant (verified by urine pregnancy test) or lactating
participation in a previous TSST study
high chronic stress as verified with the TICS-SSCS (a score of ≥ 23 on the screening scale for chronic stress meets the criterion of being chronically stressed)
major mental disorder as verified with the IDCL (depressive episode, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia and mania.)
employee of the Sponsor, one of the investigators or the CRO
use of any concomitant medication except contraceptives
any somatic disease or other condition the Investigator or their duly assigned representatives believes may affect the ability of the individual to complete the study or the interpretation of the study results
Individuals whose ability to speak for themselves lacks or can be doubted

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01703832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.