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Pharmacological Effects of Neurapas® Balance and Pascoflair® 425 mg on Brain Activity in Healthy Volunteers (NCAG 5209)

This study has been completed.
Information provided by:
Pascoe Pharmazeutische Praeparate GmbH Identifier:
First received: January 12, 2010
Last updated: May 14, 2010
Last verified: May 2010
To evaluate the pharmacological effects of two herbal medicinal products (Neurapas balance and Pascoflair 425 mg) in comparison to placebo on brain activity.

Condition Intervention Phase
Drug: Neurapas balance
Drug: Pascoflair 425 mg
Drug: P-Tabletten weiß
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Participant)
Primary Purpose: Basic Science
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

Further study details as provided by Pascoe Pharmazeutische Praeparate GmbH:

Primary Outcome Measures:
  • Z1: qEEG (total): Median change of electrical activity (qEEG: of all electrode positions) compared to Baseline (PP1 vs PP2 vs Placebo) [ Time Frame: 5 times within 4 h ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 5 times within 4 h ]
  • Comparison PP1 vs PP2 vs Placebo: Z3:qEEG (d2, beta1 (Cluster F7/T3)) [ Time Frame: 5 times wihtin 4 h ]
  • Comparison PP1 vs PP2 vs Placebo: Z4:qEEG (ME, theta (Cluster F7/T3/T6)) [ Time Frame: 5 times within 4 h ]
  • Comparison PP1 vs PP2 vs Placebo: Z5:qEEG (KLT, theta (Cluster F7/T3) + alpha (Cluster T4/T6)) [ Time Frame: 5 times within 4 h ]
  • Comparison PP1 vs PP2 vs Placebo: Z6: qEEG (Aa, all frequencies, Cluster C3/T3/P4) [ Time Frame: 5 times within 4 h ]
  • Comparison PP1 vs PP2 vs Placebo: Z7: Timely onset of effect and duration of effect [ Time Frame: 5 times within 4 h ]

Estimated Enrollment: 16
Study Start Date: January 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PP1
Neurapas balance
Drug: Neurapas balance
6 tablets single dose
Experimental: PP2
Pascoflair 425 mg
Drug: Pascoflair 425 mg
3 tablets , single dose
Placebo Comparator: PL1
P-Tabletten weiß
Drug: P-Tabletten weiß
3 tablets, single dose

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

Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01047605

Neurocode AG
Wetzlar, Germany, D-35578
Sponsors and Collaborators
Pascoe Pharmazeutische Praeparate GmbH
Principal Investigator: Winfried Wedekind, MD, PhD Neurocoed AG, Sportparkstr. 9, D-35578 Wetzlar, Germany
Study Chair: Wilfried Dimpfel, Prof Neurocode AG, Sportparkstr. 9, D-35578 Wetzlar, Germany
Study Director: Anja Braschoss, MD Pascoe Pharmazeutische Praeparate GmbH
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Anja Braschoss, MD, PASCOE pharmazeutische Praeparate GmbH Identifier: NCT01047605     History of Changes
Other Study ID Numbers: 173 S 09 PSY
2009-015827-97 ( EudraCT Number )
Study First Received: January 12, 2010
Last Updated: May 14, 2010

Keywords provided by Pascoe Pharmazeutische Praeparate GmbH:
herbal medicine
cognitive function
Neurapas balance
Healthy volunteers
Influence on quantitative electro-encephalogram (qEEG). processed this record on April 28, 2017