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

January 12, 2010
May 14, 2010
January 2010
March 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01047605 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Pharmacological Effects of Neurapas® Balance and Pascoflair® 425 mg on Brain Activity in Healthy Volunteers
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

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

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Healthy
  • Drug: Neurapas balance
    6 tablets single dose
  • Drug: Pascoflair 425 mg
    3 tablets , single dose
  • Drug: P-Tabletten weiß
    3 tablets, single dose
  • Experimental: PP1
    Neurapas balance
    Intervention: Drug: Neurapas balance
  • Experimental: PP2
    Pascoflair 425 mg
    Intervention: Drug: Pascoflair 425 mg
  • Placebo Comparator: PL1
    P-Tabletten weiß
    Intervention: Drug: P-Tabletten weiß
Dimpfel W, Koch K, Weiss G. Early effect of NEURAPAS® balance on current source density (CSD) of human EEG. BMC Psychiatry. 2011 Aug 2;11:123.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
30 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01047605
173 S 09 PSY, 2009-015827-97
No
Anja Braschoss, MD, PASCOE pharmazeutische Praeparate GmbH
Pascoe Pharmazeutische Praeparate GmbH
Not Provided
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
Pascoe Pharmazeutische Praeparate GmbH
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP