Nervous Restlessness Clinical Trial
Official title:
Treatment of Patients Suffering From Nervous Restlessness With PASCOFLAIR®
The study was carried out as a prospective, non-interventional study with the intention of subsequent process cost analyses (PCA) and also considers quality of life, drug misuse, dependence, adverse events and therapy satisfaction.
| Status | Completed |
| Enrollment | 154 |
| Est. completion date | June 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - patients suffering from nervous restlessness Exclusion Criteria: - Age < 18 years and must be able to read and understand the patient declaration of data protection and the declaration of consent - alcoholics, drug pending, addictive disorder - pregnancy or lactating - patients showing hypersensitivity against passionflower extract or against other components of the medication |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Pascoe Pharmazeutische Praeparate GmbH | Institut für Empirische Gesundheitsökonomie, Prof. Dr. Dr.med. Reinhard Rychlik,Am Ziegelfeld 28,51399 Burscheid,Germany |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change of symptom Inner Restlessness (pre - post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) | No |
| Secondary | Change of symptom sleep disturbance (pre - post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) | No |
| Secondary | Change of symptom exhaustion (pre - post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) | No |
| Secondary | Change of symptom fear (pre - post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) | No |
| Secondary | Change of symptom lack of concentration (pre - post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) | No |
| Secondary | Change of symptom transpiration (pre - post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline ) | No |
| Secondary | Change of symptom nausea (pre - post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | Change from Baseline (before treatment; week 0) to last visit (end of observation-approx. 12 weeks after baseline) | No |
| Secondary | Change of symptom trembling (pre - post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | Change from Baseline (before treatment; week 0) to last visit (end of observation - approx. 12 weeks after baseline) | No |
| Secondary | Change of symptom palpation (pre - post) | Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms" | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) | No |
| Secondary | Change of BDEPQ (Benzodiazepine Dependence Questionnaire) | The Benzodiazepine Dependence Questionnaire (BDEPQ) is a 30 item self report questionnaire designed to measure dependence on benzodiazepine tranquilisers, sedatives and hypnotics. Items cover all aspects of the dependence syndrome with the exception of withdrawal symptoms. Each item is rated on a four point likert scale referring to experiences in the last month. | Change from visit 2 (approx. 4 weeks after baseline) to last visit (end of observation- approx. 12 weeks after baseline) | No |
| Secondary | Change of RS-13 (Resilience questionnaire) (pre - post) | RS-13 is a 13 items self Report questionnaire measure the resilience | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) | No |
| Secondary | Change in EQ-5D (health questionnaire) scores (pre - post) | EQ-5D™ is a standardised instrument for use as a measure of health outcome | Change from Baseline (before treatment) to last visit (end of observation- approx. 12 weeks after baseline) | No |
| Secondary | Change of EQ-5D VAS scores (pre - post) | VAS values (Quality of Life) range from 0 (very poor) to 100 (best possible state). | Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline) | No |
| Secondary | Tolerability assess using a 5 Point scale | Assessment of tolerability using a 5 point scale (very good, good, satisfactory, bad, very bad) | Evaluation of Tolerability on visit 3 (appr. 12 weeks after baseline) | Yes |