PASCONAL NERVENTROPFEN in the Treatment of Nervous Diseases

NCT01125605 | Completed Results

• 1 other identifier: 174A10PNAL
• Study Type: observational
• Target: 325
• Locations: 1 country
• Sites: 1

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.

Conditions

Nervousness; Sleep Disorders

Keywords

PASCONAL; nervousness; nervosity; sleep disorder

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• 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))

• 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))

• 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))

• 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))

• 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))

Study Arms (3)

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

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• Males and females
• Children 1-12 years old
• Adults \>12 years old
• suffering from nervous diseases, e.g. sleep disorders due to nervousness.
• children younger than 1 year
• no nervous diseases, e.g. sleep disorders due to nervousness.
• no treatment with PASCONAL NERVENTROPFEN

Sponsors & Collaborators

• Pascoe Pharmazeutische Praeparate GmbH: lead

Study Sites (1)

Multiple German Practices

All Over Germany, Germany

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Pascoe pharmazeutische Praeparate GmbH

klinische.forschung@pascoe.de

0049 641 7960100

Study Officials

• Bianka Krick

  Pascoe Pharmazeutische Praeparate GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 18, 2010
• Study Start: May 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 14, 2015
• Results First Posted: August 27, 2012

Record last verified: 2015-03

Locations

DE (1)