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CompletedNCT02651922Updated Jul 30, 2024Results posted

Treatment of Patients Suffering From Nervous Restlessness With PASCOFLAIR®

An observational study in Nervous Restlessness, sponsored by Pascoe Pharmazeutische Praeparate GmbH. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-30.

Sponsored by Pascoe Pharmazeutische Praeparate GmbH · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
154
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Nervous Restlessness

Keywords

  • Nervous restlessness
  • Pascoflair
  • Passiflora incarnata
  • Benzodiazepine
03

In context

Lead sponsor

Pascoe Pharmazeutische Praeparate GmbH is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients suffering from nervous restlessness

Exclusion criteria

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 against passionflower extract or against other components of the medication
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
154 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  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"

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

Secondary outcomes

  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"

    Time frame: 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"

    Time frame: 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"

    Time frame: 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"

    Time frame: 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"

    Time frame: 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"

    Time frame: 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"

    Time frame: 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"

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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)

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

07

Results

Posted Jun 19, 2017

Participant flow

Participant flow — Overall Study
MilestonePASCOFLAIR Group (Verum)
Started156
Completed154
Not completed2
Withdrew: Due to exclusion criteria2

Outcome measures

PrimaryChange 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"

Time frame:
Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
Reported as:
Number · participants
Change of Symptom Inner Restlessness (Pre - Post)
participantsPASCOFLAIR Group (Verum)
improved137
unchanged3
detoriated6
SecondaryChange 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"

Time frame:
Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
Reported as:
Number · participants
Change of Symptom Sleep Disturbance (Pre - Post)
participantsPASCOFLAIR Group (Verum)
improved131
unchanged8
deteriorated7
SecondaryChange of Symptom Exhaustion (Pre - Post)

Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"

Time frame:
Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
Reported as:
Number · participants
Change of Symptom Exhaustion (Pre - Post)
participantsPASCOFLAIR Group (Verum)
improved130
unchanged7
detoriorated8
SecondaryChange of Symptom Fear (Pre - Post)

Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"

Time frame:
Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
Reported as:
Number · participants
Change of Symptom Fear (Pre - Post)
participantsPASCOFLAIR Group (Verum)
improved121
unchanged6
detoriorated10
SecondaryChange 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"

Time frame:
Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
Reported as:
Number · participants
Change of Symptom Lack of Concentration (Pre - Post)
participantsPASCOFLAIR Group (Verum)
improved123
unchanged11
detoriorated8
SecondaryChange of Symptom Transpiration (Pre - Post)

Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"

Time frame:
Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline )
Reported as:
Number · participants
Change of Symptom Transpiration (Pre - Post)
participantsPASCOFLAIR Group (Verum)
improved106
unchanged9
detoriorated6
SecondaryChange of Symptom Nausea (Pre - Post)

Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"

Time frame:
Change from Baseline (before treatment; week 0) to last visit (end of observation-approx. 12 weeks after baseline)
Reported as:
Number · participants
Change of Symptom Nausea (Pre - Post)
participantsPASCOFLAIR Group (Verum)
improved79
unchnaged7
detoriorated6
SecondaryChange of Symptom Trembling (Pre - Post)

Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"

Time frame:
Change from Baseline (before treatment; week 0) to last visit (end of observation - approx. 12 weeks after baseline)
Reported as:
Number · participants
Change of Symptom Trembling (Pre - Post)
participantsPASCOFLAIR Group (Verum)
improved91
unchanged8
deterioreated9
SecondaryChange of Symptom Palpation (Pre - Post)

Symptom was assessed in a Likert scale ranging from 0 "no symptoms at all" to 10 "very severe symptoms"

Time frame:
Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
Reported as:
Number · participants
Change of Symptom Palpation (Pre - Post)
participantsPASCOFLAIR Group (Verum)
improved117
unchanged9
deteriorated4
SecondaryChange 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).

Time frame:
Change from visit 2 (approx. 4 weeks after baseline) to last visit (end of observation- approx. 12 weeks after baseline)
Reported as:
Number · participants
Change of BDEPQ (Benzodiazepine Dependence Questionnaire)
participantsPASCOFLAIR Group (Verum)
improved91
unchanged13
deteriorated28
SecondaryChange 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).

Time frame:
Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
Reported as:
Number · participants
Change of RS-13 (Resilience Questionnaire) (Pre - Post)
participantsPASCOFLAIR Group (Verum)
improved115
unchanged3
deteriorated14
SecondaryChange 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).

Time frame:
Change from Baseline (before treatment) to last visit (end of observation- approx. 12 weeks after baseline)
Reported as:
Number · participants
Change in EQ-5D (Health Questionnaire) Scores (Pre - Post)
participantsPASCOFLAIR Group (Verum)
improved104
unchanged22
deterioreated7
SecondaryChange of EQ-5D VAS Scores (Pre - Post)

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

Time frame:
Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)
Reported as:
Number · participants
Change of EQ-5D VAS Scores (Pre - Post)
participantsPASCOFLAIR Group (Verum)
improved119
unchanged5
deteriorated11
SecondaryTolerability Assess Using a 5 Point Scale

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

Time frame:
Evaluation of Tolerability on visit 3 (appr. 12 weeks after baseline)
Reported as:
Number · participants
Tolerability Assess Using a 5 Point Scale
participantsPASCOFLAIR Group (Verum)
very good109
good35
satisfactory2
bad1
very bad1

Adverse events

Collected over The observational period was from September 2014 till June 2015. Per Patient were adrs collected for the treatment period (12 weeks).. Non-serious events are listed at a 1.0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
PASCOFLAIR Group (Verum)—0/154 (0%)3/154 (1.9%)
Most frequent other events
Most frequent other events
EventPASCOFLAIR Group (Verum)
FatigueGastrointestinal disorders3/154
Numbness in limbsNervous system disorders1/154

Baseline characteristics

A total of 156 patients participated in the study. Two patients were excluded from the analysis, because they received Benzodiazepines (Tavor, Lexostad). One patient was 17 years of age when documented in the study. The overall study population considered in the analyses was 154 patients.

Age, Customized
Age, Customized(participants)PASCOFLAIR Group (Verum)
<=18 years1
Between 18 and 65 years128
>=65 years23
missing data2
Age, Continuous
Age, Continuous(years)PASCOFLAIR Group (Verum)
Mean47.9 ± 17.1
Sex/Gender, Customized
Sex/Gender, Customized(participants)PASCOFLAIR Group (Verum)
Female115
Male38
missing data1
Region of Enrollment
Region of Enrollment(participants)PASCOFLAIR Group (Verum)
Germany154
08

Study locations

No study locations are listed for this record.

09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02651922
Lead sponsor
Pascoe Pharmazeutische Praeparate GmbH
Collaborators
Institut für Empirische Gesundheitsökonomie, Prof. Dr. Dr.med. Reinhard Rychlik,Am Ziegelfeld 28,51399 Burscheid,Germany
Responsible party
Sponsor
First posted
Jan 11, 2016
Start date
Sep 2014
Primary completion
Jun 2015
Completion
Jun 2015
Results posted
Jun 19, 2017
Last update
Jul 30, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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