Clinical trial NCT01047605: Pharmacological Effects of Neurapas® Balance and Pascoflair® 425 mg on Brain Activity in Healthy Volunteers
Official title: Evaluation of the Pharmacological Effects of NEURAPAS® Balance and PASCOFLAIR® 425 mg by Quantitative Measurement of Brain Activity in 16 Healthy Volunteers. A Single-blinded, Randomised, Placebo-controlled, 3-armed Phase-I-study With Cross-over Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: qEEG
herbal medicine
cognitive function
Neurapas balance
Pascoflair
hypericum
passionflower
valerian
Healthy volunteers
Influence on quantitative electro-encephalogram (qEEG).
Lead sponsor: Pascoe Pharmazeutische Praeparate GmbH
Sponsor class: INDUSTRY
First posted: 2010-01-13
Enrollment: 16
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To evaluate the pharmacological effects of two herbal medicinal products (Neurapas balance and Pascoflair 425 mg) in comparison to placebo on brain activity.

Detailed description: Evaluation of the pharmacological effects of Neurapas® balance and Pascoflair® 425 mg by quantitative measurement of brain activity in 16 healthy volunteers.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female volunteers
* 30 - 70 years (extremes included)
* Medical history without any study relevant pathological findings
* Written and signed informed consent

Exclusion Criteria:

* Clinically study relevant acute or chronic disorders, that can be detected by clinical investigation or medical history
* Clinical, study-relevant pathological findings of clinical oar laboratory investigations
* Clinically relevant pathological EEG findings (e.g. artefact-free parts in Screening-EEG \<30% in one recording
* Clinically relevant allergies
* positive alcohol testing on Screening, Day A, B, or C, or anamnestic
* positive drug screening test on Screening, Day A, B, or C, or anamnestic
* Intake of study relevant medication 14 days prior to active Day A, or during active study duration, based on the volunteer´s information
* Regular intake of drug with primary central nervous effects (e.g. psychoactive drugs or central acting antihypertensive drugs)
* Known hypersensitivity / allergy against herbal extracts (i.e. dry extracts of Passionflower herb, St. John´s Wort herb, Valerian root) or lactose or an other excipient of the investigational medication
* Lapp-lactase deficiency (anamnestic)
* Hypersensitivity of the skin (anamnestic)
* BMI (Body-Mass-Index) \<18 or\>30
* Abuse of caffeine, teeine, or tobacco
* Smoking in the investigational site on Day A, B, or C
* Participation in an other clinical study within 60 days prior to Screening
* Positive Pregnancy Test (on Screening, Day A, B, or C) or Lactation
* Bad compliance
* Revocation of informed consent

Primary outcomes:
measure: Z1: qEEG (total): Median change of electrical activity (qEEG: of all electrode positions) compared to Baseline (PP1 vs PP2 vs Placebo)
timeFrame: 5 times within 4 h
Secondary outcomes:
measure: Comparison PP1 vs PP2 vs Placebo: Z2: qEEG (all frequencies, Clusters): Median change of electrical activity (qEEG: of selective brain-regional clusters of electrode positions) compared to Baseline
timeFrame: 5 times within 4 h
measure: Comparison PP1 vs PP2 vs Placebo: Z3:qEEG (d2, beta1 (Cluster F7/T3))
timeFrame: 5 times wihtin 4 h
measure: Comparison PP1 vs PP2 vs Placebo: Z4:qEEG (ME, theta (Cluster F7/T3/T6))
timeFrame: 5 times within 4 h
measure: Comparison PP1 vs PP2 vs Placebo: Z5:qEEG (KLT, theta (Cluster F7/T3) + alpha (Cluster T4/T6))
timeFrame: 5 times within 4 h
measure: Comparison PP1 vs PP2 vs Placebo: Z6: qEEG (Aa, all frequencies, Cluster C3/T3/P4)
timeFrame: 5 times within 4 h
measure: Comparison PP1 vs PP2 vs Placebo: Z7: Timely onset of effect and duration of effect
timeFrame: 5 times within 4 h
Other outcomes:
Locations:
city: Wetzlar
country: Germany
facility: Neurocode AG
Study officials:
affiliation: Neurocoed AG, Sportparkstr. 9, D-35578 Wetzlar, Germany
name: Winfried Wedekind, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurocode AG, Sportparkstr. 9, D-35578 Wetzlar, Germany
name: Wilfried Dimpfel, Prof
role: STUDY_CHAIR
affiliation: Pascoe Pharmazeutische Praeparate GmbH
name: Anja Braschoss, MD
role: STUDY_DIRECTOR
References:
citation: Dimpfel W, Koch K, Weiss G. Early effect of NEURAPAS(R) balance on current source density (CSD) of human EEG. BMC Psychiatry. 2011 Aug 2;11:123. doi: 10.1186/1471-244X-11-123.