AzTrials
AzTrials

Nervous RestlessnessNCT02651922

Treatment of Patients Suffering From Nervous Restlessness With PASCOFLAIR®

An observational study of Nervous Restlessness, run by Pascoe Pharmazeutische Praeparate GmbH.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nervous Restlessness
How many people
154 participants
Where
No sites listed yet
Study dates
Sep 2014to Jun 2015
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • patients suffering from nervous restlessness

Who cannot join

  • 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

About this study

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.

Read the 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.

Keywords
Nervous restlessness, Pascoflair, Passiflora incarnata, Benzodiazepine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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"

    Measured: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)

Secondary outcomes (13)

  1. 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"

    Measured: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)

  2. 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"

    Measured: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)

  3. 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"

    Measured: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)

  4. 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"

    Measured: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)

  5. 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"

    Measured: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline )

  6. 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"

    Measured: Change from Baseline (before treatment; week 0) to last visit (end of observation-approx. 12 weeks after baseline)

  7. 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"

    Measured: Change from Baseline (before treatment; week 0) to last visit (end of observation - approx. 12 weeks after baseline)

  8. 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"

    Measured: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)

  9. 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).

    Measured: Change from visit 2 (approx. 4 weeks after baseline) to last visit (end of observation- approx. 12 weeks after baseline)

  10. 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).

    Measured: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)

  11. 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).

    Measured: Change from Baseline (before treatment) to last visit (end of observation- approx. 12 weeks after baseline)

  12. Change of EQ-5D VAS Scores (Pre - Post)

    VAS values (Quality of Life) range from 0 (very poor) to 100 (best possible state).

    Measured: Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)

  13. Tolerability Assess Using a 5 Point Scale

    Assessment of tolerability using a 5 point scale (very good, good, satisfactory, bad, very bad)

    Measured: Evaluation of Tolerability on visit 3 (appr. 12 weeks after baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2016 (estimated)
  2. Study startSep 2014
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02651922
Sponsor's protocol ID
199A14PF
Status last verified
Jul 2024
First submitted
6 Jan 2016
Last updated
30 Jul 2024
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Nervous Restlessness, run by Pascoe Pharmazeutische Praeparate GmbH.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02651922.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in