Clinical trial NCT01125605: PASCONAL NERVENTROPFEN in the Treatment of Nervous Diseases
Official title: PASCONAL NERVENTROPFEN in the Treatment of Adults and Children Suffering From Nervous Diseases (e.g. Sleep Disorders Due to Nervousness)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nervousness
Sleep Disorders
Keywords: PASCONAL
nervousness
nervosity
sleep disorder
Lead sponsor: Pascoe Pharmazeutische Praeparate GmbH
Sponsor class: INDUSTRY
First posted: 2010-05-18
Enrollment: 325
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility 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.

Exclusion criteria for documentation:

* children younger than 1 year
* no nervous diseases, e.g. sleep disorders due to nervousness.
* no treatment with PASCONAL NERVENTROPFEN

Primary outcomes:
measure: Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3
timeFrame: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)
measure: Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation
timeFrame: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)
measure: Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation
timeFrame: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)
measure: Tolerability After Visit 2 and Visit 3
timeFrame: appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)
Secondary outcomes:
measure: Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration
timeFrame: begin (visit 1) and last obvservation (could be appr. after 2 weeks (visit 2) or 4 weeks (visit 3))
measure: Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication
timeFrame: begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))
measure: Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment
timeFrame: begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))
measure: Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication
timeFrame: begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))
measure: Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment
timeFrame: begin (visit 1) and last observation (appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))
measure: Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no)
timeFrame: appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)
measure: Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration
timeFrame: appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)
Other outcomes:
Locations:
city: all over Germany
country: Germany
facility: Multiple German Practices
Study officials:
affiliation: Pascoe Pharmazeutische Praeparate GmbH
name: Bianka Krick
role: STUDY_DIRECTOR
References: