PASCONAL NERVENTROPFEN in the Treatment of Nervous Diseases

Sleep Disorders Clinical Trial

— 174  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125605
• Other study ID #: 174A10PNAL
• Status: Completed
• Phase: N/A
• First received: May 10, 2010
• Last updated: March 24, 2015
• Start date: May 2010
• Est. completion date: October 2010

Study information

• Verified date: March 2015
• Source: Pascoe Pharmazeutische Praeparate GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Nervousness
• Parasomnias
• Sleep Disorders

Locations

Country	Name	City	State
Germany	Multiple German Practices	all over Germany

Sponsors (1)

Lead Sponsor	Collaborator
Pascoe Pharmazeutische Praeparate GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)	No
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).	begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)	No
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).	begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)	No
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	appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)	No
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)	begin (visit 1) and last obvservation (could be appr. after 2 weeks (visit 2) or 4 weeks (visit 3))	No
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).	begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))	No
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).	begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))	No
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).	begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))	No
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).	begin (visit 1) and last observation (appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))	No
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".	appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)	No
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".	appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)	No