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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Pascoflair 425 mg; Drug: P-Tabletten weiß; Drug: Neurapas balance

• Registration Number: NCT01047605
• Lead Sponsor: Pascoe Pharmazeutische Praeparate GmbH

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-12
• Study First Submitted QC: 2010-01-12
• Study First Posted: 2010-01-13
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-14
• Last Update Posted: 2010-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PP2	Pascoflair 425 mg	Pascoflair 425 mg
PL1	P-Tabletten weiß	P-Tabletten weiß
PP1	Neurapas balance	Neurapas balance

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Neurocode AG; 🇩🇪 Wetzlar, Germany