StressPhase 4NCT05049447
Pharmacological Effects of Pascoflair® on Brain Activity in Patients Suffering From Test Anxiety
A Phase 4 study testing Pascoflair in people with Stress and Brain Activity, run by Pascoe Pharmazeutische Praeparate GmbH.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Stress, Brain Activity, Passiflora Incarnata
- What is being tested?
- Pascoflair
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Aug 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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).
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- 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.
About this study
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.
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.
Read the 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).
- Conditions
- Stress, Brain Activity, Passiflora Incarnata, Test Anxiety
- Being tested
- Pascoflair, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PascoflairDrug
1 x 2 tablets (single-dose)
PlaceboOther
1 x 2 tablets (single-dose)
| Study group | Role | What they receive |
|---|---|---|
| Verum arm | Active comparator | Intervention: Drug: Verum (Pascoflair) Receives: Drug: Pascoflair |
| Placebo arm | Placebo comparator | Intervention: Drug: Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day A (treatment day) - 1 day
Secondary outcomes (2)
Tolerability in a 4- Point scale
Tolerability in a 4- Point scale (very good, good, moderately, poor)
Measured: Final examination (day AB) -1 day
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.
Measured: Final examination - 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study startMay 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pascoe Pharmazeutische Praeparate GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NeuroCode AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049447
- Sponsor's protocol ID
- 200S14PF
- Status last verified
- Sep 2021
- First submitted
- 21 Sep 2015
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05049447
- Acronym / sponsor ID
- 200S14PF
- Conditions
- Stress, Brain Activity, Passiflora Incarnata, Test Anxiety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pascoe Pharmazeutische Praeparate GmbHIndustry (pharma, biotech, devices)
- Collaborators
- NeuroCode AG
- Study start
- May 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum arm | Active comparator | Drug: PascoflairIntervention: Drug: Verum (Pascoflair) |
| Placebo arm | Placebo comparator | Other: PlaceboIntervention: Drug: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pascoflair1 x 2 tablets (single-dose) | Drug | Verum arm |
| Placebo1 x 2 tablets (single-dose) | Other | Placebo arm |
Primary outcome
Comparison of verum and placebo Beta 1 power
Time frame: day A (treatment day) - 1 day
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
2 secondary outcomes
Tolerability in a 4- Point scale
Time frame: Final examination (day AB) -1 day
Correlation between questionnaire items and spectral EEG power with regard to different frequency ranges.
Time frame: Final examination - 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pascoflair in people with Stress and Brain Activity, run by Pascoe Pharmazeutische Praeparate GmbH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of verum and placebo Beta 1 power (time frame: day A (treatment day) - 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.