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Completed

NCT Number: NCT01125605

PASCONAL NERVENTROPFEN in the Treatment of Nervous Diseases

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.

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Key information

Conditions

Nervousness Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders Sleep Wake Disorders

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple German Practices

All Over Germany, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3

    Time frame: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (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).

  2. Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation

    Time frame: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)

    The severity of nervousness/restlessness was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).

  3. Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation

    Time frame: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)

    The severity of irritability/eccentricity was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).

  4. Tolerability After Visit 2 and Visit 3

    Time frame: appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)

    Assessment of tolerability at visit 2 and visit 3 well tolerated = no side effcts poor tolerated = side effects

Secondary outcomes

  1. Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration

    Time frame: begin (visit 1) and last obvservation (could be appr. after 2 weeks (visit 2) or 4 weeks (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).

    Decrease of the sumscore between baseline and last observation by concomitant medication (with and withour medication) and treatment duration (< 4 weeks and >= 4 weeks)

  2. Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication

    Time frame: begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))

    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).

  3. Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment

    Time frame: begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))

    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).

  4. Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication

    Time frame: begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))

    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).

  5. Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment

    Time frame: begin (visit 1) and last observation (appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))

    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).

  6. Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no)

    Time frame: appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)

    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".

  7. Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration

    Time frame: appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)

    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".

Sponsors and collaborators

Lead sponsor

Pascoe Pharmazeutische Praeparate GmbH

Industry

Registry information

Official study title

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

Acronym: 174

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 18, 2010
Registry last updated
Apr 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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