Clinical trial NCT02651922: Treatment of Patients Suffering From Nervous Restlessness With PASCOFLAIR®
Official title: Treatment of Patients Suffering From Nervous Restlessness With PASCOFLAIR®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nervous Restlessness
Keywords: Nervous restlessness
Pascoflair
Passiflora incarnata
Benzodiazepine
Lead sponsor: Pascoe Pharmazeutische Praeparate GmbH
Sponsor class: INDUSTRY
Collaborators: name: Institut für Empirische Gesundheitsökonomie, Prof. Dr. Dr.med. Reinhard Rychlik,Am Ziegelfeld 28,51399 Burscheid,Germany
First posted: 2016-01-11
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients had to suffer from nervous restlessness in order to be eligible for study documentation.

Brief summary: 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.

Detailed description: 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. Data were collected in collaboration with 22 physicians in Germany.

The study was designed as a one armed non-interventional study. Patients had to suffer from nervous restlessness in order to be eligible for study documentation. Participants agreed to a medical treatment with PASCOFLAIR® of 12 weeks. In this context, documented patients could take PASCOFLAIR® at the first time or could have started within the past three months before the initial visit. Furthermore, documented patients had to be older than 18 years and must be able to read and understand the patient declaration of data protection and the declaration of consent. The patient must not be an alcoholic, must not be drug dependent and have no other types of addiction. Patients who were pregnant or breast-feeding were not eligible for study participation. Furthermore, patients showing hypersensitivity against passionflower extract or against other components of the medication were excluded. The signed declaration of consent of participating patients is available.

The treatment of affected patients may not be documented, if a redemption (written or spoken) of the declaration of consent is existing or the patient takes Benzodiazepines.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Symptom Inner Restlessness (Pre - Post)
timeFrame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
Secondary outcomes:
measure: Change of Symptom Sleep Disturbance (Pre - Post)
timeFrame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
measure: Change of Symptom Exhaustion (Pre - Post)
timeFrame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
measure: Change of Symptom Fear (Pre - Post)
timeFrame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
measure: Change of Symptom Lack of Concentration (Pre - Post)
timeFrame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
measure: Change of Symptom Transpiration (Pre - Post)
timeFrame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline )
measure: Change of Symptom Nausea (Pre - Post)
timeFrame: Change from Baseline (before treatment; week 0) to last visit (end of observation-approx. 12 weeks after baseline)
measure: Change of Symptom Trembling (Pre - Post)
timeFrame: Change from Baseline (before treatment; week 0) to last visit (end of observation - approx. 12 weeks after baseline)
measure: Change of Symptom Palpation (Pre - Post)
timeFrame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
measure: Change of BDEPQ (Benzodiazepine Dependence Questionnaire)
timeFrame: Change from visit 2 (approx. 4 weeks after baseline) to last visit (end of observation- approx. 12 weeks after baseline)
measure: Change of RS-13 (Resilience Questionnaire) (Pre - Post)
timeFrame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
measure: Change in EQ-5D (Health Questionnaire) Scores (Pre - Post)
timeFrame: Change from Baseline (before treatment) to last visit (end of observation- approx. 12 weeks after baseline)
measure: Change of EQ-5D VAS Scores (Pre - Post)
timeFrame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
measure: Tolerability Assess Using a 5 Point Scale
timeFrame: Evaluation of Tolerability on visit 3 (appr. 12 weeks after baseline)
Other outcomes:
Locations:
Study officials:
References: