Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| NeuroCode AG | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum arm | Active Comparator | Intervention: Drug: Verum (Pascoflair) |
|
| Placebo arm | Placebo Comparator | Intervention: Drug: Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pascoflair | Drug | 1 x 2 tablets (single-dose) |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | day A (treatment day) - 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability in a 4- Point scale | Tolerability in a 4- Point scale (very good, good, moderately, poor) | Final examination (day AB) -1 day |
| Correlation between questionnaire items and spectral EEG power with regard to different frequency ranges. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
1 x 2 tablets (single-dose) |
|
Correlation between questionnaire items and spectral EEG power with regard to different frequency ranges.
| Final examination - 1 day |