Treatment of Patients Suffering From Nervous Restlessness With PASCOFLAIR®

July 4, 2024 updated by: Pascoe Pharmazeutische Praeparate GmbH
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
154

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of Symptom Inner Restlessness (Pre - Post)
Time Frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of Symptom Sleep Disturbance (Pre - Post)
Time Frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
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)
Time Frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
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)
Time Frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
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)
Time Frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
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)
Time Frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline )
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)
Time Frame: Change from Baseline (before treatment; week 0) to last visit (end of observation-approx. 12 weeks after baseline)
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)
Time Frame: Change from Baseline (before treatment; week 0) to last visit (end of observation - approx. 12 weeks after baseline)
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)
Time Frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
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)
Time Frame: Change from visit 2 (approx. 4 weeks after baseline) to last visit (end of observation- approx. 12 weeks after baseline)

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)
Time Frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
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)
Time Frame: Change from Baseline (before treatment) to last visit (end of observation- approx. 12 weeks after baseline)
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)
Time Frame: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
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
Time Frame: Evaluation of Tolerability on visit 3 (appr. 12 weeks after baseline)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pascoe Pharmazeutische Praeparate GmbH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut für Empirische Gesundheitsökonomie, Prof. Dr. Dr.med. Reinhard Rychlik,Am Ziegelfeld 28,51399 Burscheid,Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 199A14PF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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