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
Sponsored by
About this trial
This is an interventional treatment trial for Stress
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.
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.
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
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
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
No
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
Learn more about this trial
Pharmacological Effects of Pascoflair® on Brain Activity in Patients Suffering From Test Anxiety
We'll reach out to this number within 24 hrs