Nervousness, Sleep Disorders
Conditions
Keywords
PASCONAL, nervousness, nervosity, sleep disorder
Brief summary
The purpose of this observational study is to give an overview of the use of PASCONAL NERVENTROPFEN in a 2-4 week treatment of nervous diseases, especially sleep disorders due to nervousness.
Detailed description
The purpose of this observational study is to give an overview of the use of PASCONAL NERVENTROPFEN in a 2-4 week treatment of nervous diseases, especially sleep disorders due to nervousness. Efficacy and tolerability of the drug will be assessed. Special regard will be taken to the administration management, dose regimen, and to the effectiveness and safety in special patient groups (children 1-12 years of age), in relation to treatment conformity to the Summary of Product Characteristics (SmPC).
Interventions
None listed
Sponsors
Pascoe Pharmazeutische Praeparate GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Due to the design as an Observational Study no inclusion or
Exclusion criteria
for therapy are named. The included patient group is described under Cohort / Group. Observational Criteria (=inclusion criteria for documentation): * Males and females * Children 1-12 years old * Adults \>12 years old * suffering from nervous diseases, e.g. sleep disorders due to nervousness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3 | begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3) | The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints). |
| Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation | begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3) | The severity of nervousness/restlessness was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints). |
| Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation | begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3) | The severity of irritability/eccentricity was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints). |
| Tolerability After Visit 2 and Visit 3 | appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3) | Assessment of tolerability at visit 2 and visit 3 well tolerated = no side effcts poor tolerated = side effects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment | begin (visit 1) and last observation (appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)) | The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories improved, unchanged and worsened. For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was \> 0). |
| Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration | begin (visit 1) and last obvservation (could be appr. after 2 weeks (visit 2) or 4 weeks (visit 3)) | The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints). Decrease of the sumscore between baseline and last observation by concomitant medication (with and withour medication) and treatment duration (\< 4 weeks and \>= 4 weeks) |
| Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration | appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3) | Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication. The last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories PASCONAL® better, No difference and PASCONAL® worse. |
| Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no) | appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3) | Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication. The last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories PASCONAL® better, No difference and PASCONAL® worse. |
| Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication | begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)) | The symptom nervousness/restlessnesswas analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories improved, unchanged and worsened. For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was \> 0). |
| Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment | begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)) | The symptom nervousness/restlessness was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories improved, unchanged and worsened. For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was \> 0). |
| Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication | begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)) | The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories improved, unchanged and worsened. For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was \> 0). |
Countries
Germany
Participant flow
Recruitment details
Physicians who were registered in the past with the treatment focus on central nervous system / psyche. The recruitment of the participating physicians was done by the field service of PASCOE.
Pre-assignment details
It was an non-inteventional observational study with 3 visits.
Participants by arm
| Arm | Count |
|---|---|
| Observational Group Pasconal Nerventropfen | 325 |
| Total | 325 |
Baseline characteristics
| Characteristic | Observational Group |
|---|---|
| Age, Categorical <=18 years | 72 Participants |
| Age, Categorical >=65 years | 41 Participants |
| Age, Categorical Between 18 and 65 years | 212 Participants |
| Concomitant medication with concomitant medication | 176 participants |
| Concomitant medication without concomitant medication | 149 participants |
| Duration of disease years | 2.0 years STANDARD_DEVIATION 3.8 |
| Previous treatment of inclusion diagnosis without previous treatment of inclusion diagnosis | 80 participants |
| Previous treatment of inclusion diagnosis with previous treatment of inclusion diagnosis | 245 participants |
| Sex: Female, Male Female | 229 Participants |
| Sex: Female, Male Male | 96 Participants |
| State of inclusion diagnosis acute (<= 2 months) | 43 participants |
| State of inclusion diagnosis missing data | 119 participants |
| State of inclusion diagnosis subchronic/chronic (> 2 months) | 163 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 326 |
| serious Total, serious adverse events | 0 / 326 |
Outcome results
Primary
Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation
The severity of irritability/eccentricity was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).
Time frame: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)
Population: descriptive; for all partcipations with values at the visits
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Visit 1 | Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation | 0=not present | 0 participants |
| Visit 1 | Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation | 1=mild | 86 participants |
| Visit 1 | Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation | 2=moderate | 140 participants |
| Visit 1 | Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation | 3=Strong | 67 participants |
| Visit 2 | Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation | 1=mild | 163 participants |
| Visit 2 | Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation | 2=moderate | 72 participants |
| Visit 2 | Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation | 3=Strong | 15 participants |
| Visit 2 | Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation | 0=not present | 41 participants |
| Visit 3 | Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation | 2=moderate | 25 participants |
| Visit 3 | Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation | 1=mild | 136 participants |
| Visit 3 | Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation | 3=Strong | 6 participants |
| Visit 3 | Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation | 0=not present | 111 participants |
| Last Observation | Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation | 3=Strong | 9 participants |
| Last Observation | Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation | 1=mild | 142 participants |
| Last Observation | Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation | 0=not present | 115 participants |
| Last Observation | Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation | 2=moderate | 27 participants |
Primary
Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation
The severity of nervousness/restlessness was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).
Time frame: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)
Population: descriptive; for all partcipations with values at the visits
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Visit 1 | Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation | 3=Strong | 79 participants |
| Visit 1 | Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation | 2=moderate | 166 participants |
| Visit 1 | Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation | 0=not present | 0 participants |
| Visit 1 | Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation | 1=mild | 63 participants |
| Visit 2 | Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation | 1=mild | 171 participants |
| Visit 2 | Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation | 0=not present | 23 participants |
| Visit 2 | Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation | 2=moderate | 98 participants |
| Visit 2 | Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation | 3=Strong | 14 participants |
| Visit 3 | Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation | 2=moderate | 26 participants |
| Visit 3 | Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation | 3=Strong | 9 participants |
| Visit 3 | Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation | 1=mild | 180 participants |
| Visit 3 | Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation | 0=not present | 78 participants |
| Last Observation | Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation | 3=Strong | 11 participants |
| Last Observation | Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation | 0=not present | 79 participants |
| Last Observation | Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation | 1=mild | 789 participants |
| Last Observation | Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation | 2=moderate | 29 participants |
Primary
Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3
The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints).
Time frame: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)
Population: descriptive; for all partcipations with values at the visits
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Visit 1 | Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3 | 15.8 units on a scale | Standard Deviation 6.1 |
| Visit 2 | Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3 | 9.2 units on a scale | Standard Deviation 5.6 |
| Visit 3 | Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3 | 5.1 units on a scale | Standard Deviation 4.5 |
| Last Observation | Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3 | 6.2 units on a scale | Standard Deviation 5.2 |
Primary
Tolerability After Visit 2 and Visit 3
Assessment of tolerability at visit 2 and visit 3 well tolerated = no side effcts poor tolerated = side effects
Time frame: appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)
Population: descriptive; for safety 326 patients were analysed; 1 patient had no efficacy values and were not analysed for efficacy; so a discrepancy between 325 patients (for efficacy) and 326 (for safety) occured
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Visit 1 | Tolerability After Visit 2 and Visit 3 | poor tolerated | 13 participants |
| Visit 1 | Tolerability After Visit 2 and Visit 3 | well tolerated | 313 participants |
| Visit 2 | Tolerability After Visit 2 and Visit 3 | well tolerated | 303 participants |
| Visit 2 | Tolerability After Visit 2 and Visit 3 | poor tolerated | 23 participants |
Secondary
Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration
The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints). Decrease of the sumscore between baseline and last observation by concomitant medication (with and withour medication) and treatment duration (\< 4 weeks and \>= 4 weeks)
Time frame: begin (visit 1) and last obvservation (could be appr. after 2 weeks (visit 2) or 4 weeks (visit 3))
Population: exploratively, all participations with values
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Visit 1 | Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration | with concomitant medication | 15.9 units on a scale | Standard Deviation 5.5 |
| Visit 1 | Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration | without concomitant medication | 15.7 units on a scale | Standard Deviation 6.2 |
| Visit 1 | Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration | < 4 weeks treatment duration | 14.3 units on a scale | Standard Deviation 5.3 |
| Visit 1 | Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration | >= 4 weeks treatment duration | 16.1 units on a scale | Standard Deviation 6.2 |
| Visit 2 | Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration | >= 4 weeks treatment duration | 5.9 units on a scale | Standard Deviation 4.9 |
| Visit 2 | Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration | with concomitant medication | 7.7 units on a scale | Standard Deviation 5.6 |
| Visit 2 | Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration | < 4 weeks treatment duration | 7.4 units on a scale | Standard Deviation 6 |
| Visit 2 | Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration | without concomitant medication | 5.8 units on a scale | Standard Deviation 5 |
Comparison: decrease of the sum score between baseline (visit 1) and last observation was exploratively analysedp-value: 0.0033ANCOVA
Comparison: decrease of the sum score between baseline (visit1) and last observation by duration of treatmentp-value: 0.0002ANCOVA
Secondary
Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication
The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories improved, unchanged and worsened. For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was \> 0).
Time frame: begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))
Population: exploratively, all participations with values
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Visit 1 | Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication | improved | 43 participants |
| Visit 1 | Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication | unchanged | 21 participants |
| Visit 1 | Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication | worsened | 2 participants |
| Visit 2 | Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication | improved | 195 participants |
| Visit 2 | Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication | unchanged | 30 participants |
| Visit 2 | Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication | worsened | 2 participants |
p-value: 0.0006Fisher Exact
Secondary
Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment
The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories improved, unchanged and worsened. For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was \> 0).
Time frame: begin (visit 1) and last observation (appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))
Population: exploratively, all participations with values
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Visit 1 | Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment | improved | 40 participants |
| Visit 1 | Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment | unchanged | 19 participants |
| Visit 1 | Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment | worsened | 2 participants |
| Visit 2 | Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment | improved | 198 participants |
| Visit 2 | Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment | unchanged | 32 participants |
| Visit 2 | Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment | worsened | 2 participants |
p-value: 0.0016Fisher Exact
Secondary
Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication
The symptom nervousness/restlessnesswas analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories improved, unchanged and worsened. For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was \> 0).
Time frame: begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))
Population: exploratively, all participations with values
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Visit 1 | Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication | improved | 46 participants |
| Visit 1 | Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication | unchanged | 19 participants |
| Visit 1 | Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication | worsened | 3 participants |
| Visit 2 | Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication | improved | 206 participants |
| Visit 2 | Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication | unchanged | 32 participants |
| Visit 2 | Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication | worsened | 2 participants |
p-value: 0.0014Fisher Exact
Secondary
Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment
The symptom nervousness/restlessness was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories improved, unchanged and worsened. For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was \> 0).
Time frame: begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))
Population: exploratively, all participations with values
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Visit 1 | Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment | improved | 46 participants |
| Visit 1 | Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment | unchanged | 16 participants |
| Visit 1 | Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment | worsened | 3 participants |
| Visit 2 | Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment | improved | 206 participants |
| Visit 2 | Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment | unchanged | 35 participants |
| Visit 2 | Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment | worsened | 2 participants |
p-value: 0.0125Fisher Exact
Secondary
Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no)
Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication. The last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories PASCONAL® better, No difference and PASCONAL® worse.
Time frame: appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)
Population: exploratively, all participations with values
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Visit 1 | Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no) | PASCONAL better | 40 participants |
| Visit 1 | Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no) | No difference | 18 participants |
| Visit 1 | Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no) | PACONAL worse | 10 participants |
| Visit 2 | Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no) | PASCONAL better | 128 participants |
| Visit 2 | Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no) | No difference | 34 participants |
| Visit 2 | Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no) | PACONAL worse | 12 participants |
p-value: 0.0504Fisher Exact
Secondary
Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration
Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication. The last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories PASCONAL® better, No difference and PASCONAL® worse.
Time frame: appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)
Population: exploratively, all participations with values
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Visit 1 | Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration | PASCONAL better | 25 participants |
| Visit 1 | Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration | No difference | 16 participants |
| Visit 1 | Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration | PACONAL worse | 11 participants |
| Visit 2 | Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration | PASCONAL better | 143 participants |
| Visit 2 | Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration | No difference | 36 participants |
| Visit 2 | Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration | PACONAL worse | 11 participants |
p-value: 0.0002Fisher Exact