PASCONAL NERVENTROPFEN in the Treatment of Nervous Diseases

Study Overview
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Brief Summary
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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
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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).

Official Title
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PASCONAL NERVENTROPFEN in the Treatment of Adults and Children Suffering From Nervous Diseases (e.g. Sleep Disorders Due to Nervousness)

Conditions
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Nervousness, Sleep Disorders

Participation Criteria
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Eligibility Criteria
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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. Exclusion criteria for documentation: children younger than 1 year no nervous diseases, e.g. sleep disorders due to nervousness. no treatment with PASCONAL NERVENTROPFEN

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults > 12 years<br>adult patients and patients older than 12 years | |
| Children 6-12 years<br>children between 6 and 12 years | |
| Children 1-6 years<br>children between 1 and 6 years | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3) | 
| 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). | begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3) | 
| 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). | begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3) | 
| 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 | appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | begin (visit 1) and last obvservation (could be appr. after 2 weeks (visit 2) or 4 weeks (visit 3)) | 
| 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). | begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)) | 
| 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). | begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)) | 
| 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). | begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)) | 
| 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). | begin (visit 1) and last observation (appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)) | 
| 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. | appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3) | 
| 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. | appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PASCONAL, nervousness, nervosity, sleep disorder