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Pharmacological Effects of Pascoflair® on Brain Activity in Patients Suffering From Test Anxiety

Primary Purpose

Stress, Brain Activity, Passiflora Incarnata

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Pascoflair

Placebo

About this trial

This is an interventional treatment trial for Stress

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Healthy male and female subjects.
Age between 18 and 40 years (both included).
Anxiety questionnaire PAF (pre-selection of subjects) - values above T> 60 are regarded as conclusive.
Inconclusive case history and diagnosis.
Subject must be capable of giving informed consent.
Acceptance of written consent to participate in the study after education in written and oral form (informed consent).

Exclusion Criteria:

Acute or chronic disease with an impact on the study, which becomes obvious by case history or clinical examination.
Clinically relevant pathological findings from clinical and laboratory findings.
Presence of clinically relevant pathological EEG features or artifact-free portion of the screening EEG <30%.
Clinically relevant allergic symptoms.
Detection of alcohol at the time of initial examination (day SC) or on study day A (positive alcohol test) or by case history.
Detection of drugs (positive drug test) at the time of initial examination (day SC).
Consumption of clinically relevant medication during last fourteen days before and during the active study period based on the notification of the subject or his case history.
Consumption of medication with primarily central action (i.e. psychotropic drugs or centrally acting antihypertensives).
Known intolerance / hypersensitivity (allergy) to plant derived extracts (Passion flower dry extract) or any of the ingredients of the investigational product (anamnestic).
Presence of a rare, genetic disease such as fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase deficiency (anamnestic).
BMI (Body Mass Index) <18 or> 32.
Consumption of unusual quantities or misuse of coffee (more than 4 cups a day), tea (more than 4 cups a day) or tobacco (more than 20 cigarettes per day).
Smoking on day of A.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Verum arm

Placebo arm

Arm Description

Intervention: Drug: Verum (Pascoflair)

Intervention: Drug: Placebo

Outcomes

Primary Outcome Measures

Comparison of verum and placebo Beta 1 power

Comparison of verum and placebo efficacy is performed on electric power in 17 different brain regions within six frequency ranges defined as target parameters in the presence of different stress inducing cognitive tests or exciting video scenes

Secondary Outcome Measures

Tolerability in a 4- Point scale

Tolerability in a 4- Point scale (very good, good, moderately, poor)

Correlation between questionnaire items and spectral EEG power with regard to different frequency ranges.

Full Information

NCT ID

NCT05049447

First Posted

September 21, 2015

Last Updated

September 16, 2021

Sponsor

Pascoe Pharmazeutische Praeparate GmbH

Collaborators

NeuroCode AG

1. Study Identification

Unique Protocol Identification Number

NCT05049447

Brief Title

Pharmacological Effects of Pascoflair® on Brain Activity in Patients Suffering From Test Anxiety

Official Title

Proof of Effectiveness of Pascoflair Using Qantitative Measurement of Electric Brain Activity During Examination Stress in 40 Subjects Suffering From Test Anxiety. A Double-blind, Randomized, Placebo-controlled, 2-armed, Phase IV Study in Parallel Design.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

May 2015 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pascoe Pharmazeutische Praeparate GmbH

Collaborators

NeuroCode AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Proof of effectiveness of Pascoflair using qantitative measurement of electric brain activity during examination stress in 40 subjects suffering from test anxiety. A double-blind, randomized, placebo-controlled, 2-armed, Phase IV study in parallel design.

Detailed Description

Anxiolytic effects of PASCOFLAIR® shall be tested in subjects suffering from test anxiety after single intake by aid of a newly developed, validated method consisting of a combination of eye tracking (following glances) with neurocode tracking (quantitative EEG with a time resolution of 364 ms).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress, Brain Activity, Passiflora Incarnata, Test Anxiety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Verum arm

Arm Type

Active Comparator

Arm Description

Intervention: Drug: Verum (Pascoflair)

Arm Title

Placebo arm

Arm Type

Placebo Comparator

Arm Description

Intervention: Drug: Placebo

Intervention Type

Drug

Intervention Name(s)

Pascoflair

Intervention Description

1 x 2 tablets (single-dose)

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

1 x 2 tablets (single-dose)

Primary Outcome Measure Information:

Title

Comparison of verum and placebo Beta 1 power

Description

Time Frame

day A (treatment day) - 1 day

Secondary Outcome Measure Information:

Title

Tolerability in a 4- Point scale

Description

Tolerability in a 4- Point scale (very good, good, moderately, poor)

Time Frame

Final examination (day AB) -1 day

Title

Correlation between questionnaire items and spectral EEG power with regard to different frequency ranges.

Description

Correlation between questionnaire items and spectral EEG power with regard to different frequency ranges.

Time Frame

Final examination - 1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy male and female subjects. Age between 18 and 40 years (both included). Anxiety questionnaire PAF (pre-selection of subjects) - values above T> 60 are regarded as conclusive. Inconclusive case history and diagnosis. Subject must be capable of giving informed consent. Acceptance of written consent to participate in the study after education in written and oral form (informed consent). Exclusion Criteria: Acute or chronic disease with an impact on the study, which becomes obvious by case history or clinical examination. Clinically relevant pathological findings from clinical and laboratory findings. Presence of clinically relevant pathological EEG features or artifact-free portion of the screening EEG <30%. Clinically relevant allergic symptoms. Detection of alcohol at the time of initial examination (day SC) or on study day A (positive alcohol test) or by case history. Detection of drugs (positive drug test) at the time of initial examination (day SC). Consumption of clinically relevant medication during last fourteen days before and during the active study period based on the notification of the subject or his case history. Consumption of medication with primarily central action (i.e. psychotropic drugs or centrally acting antihypertensives). Known intolerance / hypersensitivity (allergy) to plant derived extracts (Passion flower dry extract) or any of the ingredients of the investigational product (anamnestic). Presence of a rare, genetic disease such as fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase deficiency (anamnestic). BMI (Body Mass Index) <18 or> 32. Consumption of unusual quantities or misuse of coffee (more than 4 cups a day), tea (more than 4 cups a day) or tobacco (more than 20 cigarettes per day). Smoking on day of A.

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Pharmacological Effects of Pascoflair® on Brain Activity in Patients Suffering From Test Anxiety

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