NCT01047605

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

May 17, 2010

Status Verified

May 1, 2010

Enrollment Period

2 months

First QC Date

January 12, 2010

Last Update Submit

May 14, 2010

Conditions

Healthy

Keywords

qEEGherbal medicinecognitive functionNeurapas balancePascoflairhypericumpassionflowervalerianHealthy volunteersInfluence on quantitative electro-encephalogram (qEEG).

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (3)

PP1

EXPERIMENTAL

Neurapas balance

Drug: Neurapas balance

PP2

EXPERIMENTAL

Pascoflair 425 mg

Drug: Pascoflair 425 mg

PL1

PLACEBO COMPARATOR

P-Tabletten weiß

Drug: P-Tabletten weiß

Interventions

Neurapas balanceDRUG

6 tablets single dose

PP1
Pascoflair 425 mgDRUG

3 tablets , single dose

PP2
P-Tabletten weißDRUG

3 tablets, single dose

PL1

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male and female volunteers
  • years (extremes included)
  • Medical history without any study relevant pathological findings
  • Written and signed informed consent

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurocode AG

Wetzlar, D-35578, Germany

Location

Related Publications (1)

  • 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.

    PMID: 21810233DERIVED

Study Officials

  • Winfried Wedekind, MD, PhD

    Neurocoed AG, Sportparkstr. 9, D-35578 Wetzlar, Germany

    PRINCIPAL INVESTIGATOR

  • Wilfried Dimpfel, Prof

    Neurocode AG, Sportparkstr. 9, D-35578 Wetzlar, Germany

    STUDY CHAIR

  • Anja Braschoss, MD

    Pascoe Pharmazeutische Praeparate GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 12, 2010

First Posted

January 13, 2010

Study Start

January 1, 2010

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

May 17, 2010

Record last verified: 2010-05

Locations

DE(1)