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

This study has been completed.
Sponsor:
Information provided by:
Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier:
NCT01047605
First received: January 12, 2010
Last updated: May 14, 2010
Last verified: May 2010
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Comparison PP1 vs PP2 vs Placebo: Z3:qEEG (d2, beta1 (Cluster F7/T3)) [ Time Frame: 5 times wihtin 4 h ] [ Designated as safety issue: No ]
  • Comparison PP1 vs PP2 vs Placebo: Z4:qEEG (ME, theta (Cluster F7/T3/T6)) [ Time Frame: 5 times within 4 h ] [ Designated as safety issue: No ]
  • Comparison PP1 vs PP2 vs Placebo: Z5:qEEG (KLT, theta (Cluster F7/T3) + alpha (Cluster T4/T6)) [ Time Frame: 5 times within 4 h ] [ Designated as safety issue: No ]
  • Comparison PP1 vs PP2 vs Placebo: Z6: qEEG (Aa, all frequencies, Cluster C3/T3/P4) [ Time Frame: 5 times within 4 h ] [ Designated as safety issue: No ]
  • Comparison PP1 vs PP2 vs Placebo: Z7: Timely onset of effect and duration of effect [ Time Frame: 5 times within 4 h ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047605

Locations
Germany
Neurocode AG
Wetzlar, Germany, D-35578
Sponsors and Collaborators
Pascoe Pharmazeutische Praeparate GmbH
Investigators
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

No publications provided by Pascoe Pharmazeutische Praeparate GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anja Braschoss, MD, PASCOE pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier: NCT01047605     History of Changes
Other Study ID Numbers: 173 S 09 PSY, 2009-015827-97
Study First Received: January 12, 2010
Last Updated: May 14, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Pascoe Pharmazeutische Praeparate GmbH:
qEEG
herbal medicine
cognitive function
Neurapas balance
Pascoflair
hypericum
passionflower
valerian
Healthy volunteers
Influence on quantitative electro-encephalogram (qEEG).

ClinicalTrials.gov processed this record on October 21, 2014