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Explorative Efficacy Profile of Neurexan® in an Experimental Acute Stress Setting in Healthy Subjects

NCT01703819 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2015-02-11

Study results available
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Summary

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

Conditions

  • Acute Stress Reaction

Interventions

DRUG

Neurexan®

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

OTHER

Placebo

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

Sponsors & Collaborators

  • Biologische Heilmittel Heel GmbH

    lead INDUSTRY

Principal Investigators

  • Manfred Schedlowski, PhD · Institut für Medizinische Psychologie und Verhaltensimmunbiologie Universitätsklinikum Essen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
31 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01703819 on ClinicalTrials.gov