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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01125579
Other study ID # 162A07NPB
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2008
Est. completion date November 2008

Study information

Verified date May 2010
Source Pascoe Pharmazeutische Praeparate GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Purpose: To document data on effectiveness of NEURAPAS® balance (NPB) in the treatment of nervous restlessness in children aged 6 to 12. Each patient is treated with NPB. No placebo group is established. Course and severity of symptoms is documented by a questionnaire on 13 common symptoms of nervous restlessness and a Visual Analogue Scale (VAS). A standardized questionnaire (Parent Child Behaviour Checklist (CBCL/4-18)) is completed. Choice and doses of therapy are at the respective physician's discretion. The planned treatment and observation period is 2 - 4 weeks.


Description:

Purpose: To document data on effectiveness of NEURAPAS® balance (NPB) in the treatment of nervous restlessness in children aged 6 to 12. Patients and methods: A prospective, non-interventional, non-randomized, observational study conducted in German pediatric practices. Each patient is treated with NPB. No placebo group is established. As subjective criteria to document course and severity of symptoms, a questionnaire on 13 common symptoms of nervous restlessness and a Visual Analogue Scale (VAS) is used. As an objective criterion, a standardized questionnaire (Parent Child Behaviour Checklist (CBCL/4-18)) is completed. Choice and doses of therapy are at the respective physician's discretion. The planned treatment and observation period is 2 - 4 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 115
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender All
Age group 6 Years to 11 Years
Eligibility Due to the design as an Observational Study no inclusion or exclusion criteria are named. The included patient group is described under "Cohort / Group". Observational Criteria: - age 6 - 11 (extremes included) - nervous restlessness and/or - agitated depression and/or - affective disorders Exclusion Criteria: - patients <6 and >12 years of age

Study Design


Locations

Country Name City State
Germany multiple German Paediatric Practices Giessen Hessen

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 Change in Parent Child Behaviour Checklist (CBCL/4-18) Parent Child Behaviour Checklist (CBCL/4-18), standardized questionnaire after 2 + 4 weeks´ treatment
Secondary Tolerability of NEURAPAS balance kind, frequency, duration, outcome of ADR after 2 + 4 weeks
Secondary Change of 13 common symptoms of nervous restlessness Questionnaire on 13 common symptoms of nervous restlessness in children after 2 + 4 weeks
Secondary Change of the impact of the child´s complaints on daily family life (VAS) Visual Analogue Scale (VAS)to assess the impact of the child´s complaints on daily family life after 2 + 4 weeks
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