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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Neurapas balance; Drug: Pascoflair 425 mg; Drug: P-Tabletten weiß

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Wetzlar, Germany, D-35578
    • NeuroCode AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: January 12, 2010
• First Submitted That Met QC Criteria: January 12, 2010
• First Posted (Estimate): January 13, 2010

Study Record Updates

• Last Update Posted (Estimate): May 17, 2010
• Last Update Submitted That Met QC Criteria: May 14, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Healthy volunteers; cognitive function; herbal medicine; qEEG; Neurapas balance; Pascoflair; hypericum; passionflower; valerian; Influence on quantitative electro-encephalogram (qEEG).
• Other Study ID Numbers: 173 S 09 PSY; 2009-015827-97 (EudraCT Number)