PASCONAL NERVENTROPFEN in the Treatment of Nervous Diseases (174)

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Disorders; 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).

• Study Type: Observational
• Enrollment (Actual): 325

Contacts and Locations

Study Locations

• Germany
  • all over Germany, Germany
    • Multiple German Practices

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Observational groups

Patients (adults and children 1-12 years of age) suffering from nervous diseases, e.g. sleep-disturbances due to nervousness.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Adults > 12 years; adult patients and patients older than 12 years
Children 6-12 years; children between 6 and 12 years
Children 1-6 years; children between 1 and 6 years

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Pascoe Pharmazeutische Praeparate GmbH
• Investigators: Study Director: Bianka Krick, Pascoe Pharmazeutische Praeparate GmbH

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: May 10, 2010
• First Submitted That Met QC Criteria: May 17, 2010
• First Posted (Estimate): May 18, 2010

Study Record Updates

• Last Update Posted (Estimate): April 14, 2015
• Last Update Submitted That Met QC Criteria: March 24, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: sleep disorder; nervousness; PASCONAL; nervosity
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: 174A10PNAL