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.

Study Overview

• Status: Completed
• Conditions: Nervous Restlessness

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.

• Study Type: Observational
• Enrollment (Actual): 154

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients had to suffer from nervous restlessness in order to be eligible for study documentation.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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 )
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)
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)
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)
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. BDEPQ score ranges from 0 (no dependence) to 85 (most severe dependence).	Change from visit 2 (approx. 4 weeks after baseline) to last visit (end of observation- approx. 12 weeks after baseline)
Change of RS-13 (Resilience Questionnaire) (Pre - Post)	RS-13 is a 13 items self Report questionnaire measure the resilience, which applies a reliance scale ranging from 13 (lowest stress resistance) to 91 (highest stress resistance).	Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
Change in EQ-5D (Health Questionnaire) Scores (Pre - Post)	EQ-5D™ is a standardised instrument for use as a measure of health Outcome The EQ-5D assesses five aspects of QoL: mobility, self-care, usual activity, pain/discomfort and anxiety/depression. An EQ-5D profile score of 0 points represents the worst QoL (death), while 1 point stands for full health. Data analysis was performed according to the EuroQol manual. The EQ-VAS ranges from 0 (worst QoL) to 100 (best QoL).	Change from Baseline (before treatment) to last visit (end of observation- approx. 12 weeks after baseline)
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)
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)

Collaborators and Investigators

• Sponsor: Pascoe Pharmazeutische Praeparate GmbH
• Collaborators: Institut für Empirische Gesundheitsökonomie, Prof. Dr. Dr.med. Reinhard Rychlik,Am Ziegelfeld 28,51399 Burscheid,Germany

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: January 6, 2016
• First Submitted That Met QC Criteria: January 8, 2016
• First Posted (Estimated): January 11, 2016

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 4, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Benzodiazepine; Pascoflair; Nervous restlessness; Passiflora incarnata
• Additional Relevant MeSH Terms: Behavioral Symptoms; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Dyskinesias; Psychomotor Disorders; Aberrant Motor Behavior in Dementia; Psychomotor Agitation
• Other Study ID Numbers: 199A14PF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO