Nervousness174NCT01125605

PASCONAL NERVENTROPFEN in the Treatment of Nervous Diseases

An observational study of Nervousness and Sleep Disorders, run by Pascoe Pharmazeutische Praeparate GmbH at 1 site in Germany.

Completed

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

Official record

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Trial summary

The purpose of this observational study is to give an overview of the use of PASCONAL NERVENTROPFEN in a 2-4 week treatment of nervous diseases, especially sleep disorders due to nervousness. Read more about this study

Who is it for?: Ages 1 year and older
Conditions the study is for: Nervousness, Sleep Disorders
How many people: 325 participants
Where: 1 siteGermany
Study dates: May 2010to Oct 2010
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 1 year and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Observational groups Patients (adults and children 1-12 years of age) suffering from nervous diseases, e.g. sleep-disturbances due to nervousness.

Who may be able to join

None listed.

Who cannot join

children younger than 1 year
no nervous diseases, e.g. sleep disorders due to nervousness.
no treatment with PASCONAL NERVENTROPFEN

Trial locations and contacts

1 site in 1 country.

Germany1 site

Multiple German Practices
All Over Germany

Other trials in Germany

About this study

Official title: PASCONAL NERVENTROPFEN in the Treatment of Adults and Children Suffering From Nervous Diseases (e.g. Sleep Disorders Due to Nervousness)

The purpose of this observational study is to give an overview of the use of PASCONAL NERVENTROPFEN in a 2-4 week treatment of nervous diseases, especially sleep disorders due to nervousness.

Read the detailed description

The purpose of this observational study is to give an overview of the use of PASCONAL NERVENTROPFEN in a 2-4 week treatment of nervous diseases, especially sleep disorders due to nervousness.

Efficacy and tolerability of the drug will be assessed. Special regard will be taken to the administration management, dose regimen, and to the effectiveness and safety in special patient groups (children 1-12 years of age), in relation to treatment conformity to the Summary of Product Characteristics (SmPC).

Conditions: Nervousness, Sleep Disorders
Keywords: PASCONAL, nervousness, nervosity, sleep disorder
Medical subject headings: Sleep Wake Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01125605
Study group	Role	What they receive
Adults > 12 years		adult patients and patients older than 12 years
Children 6-12 years		children between 6 and 12 years
Children 1-6 years		children between 1 and 6 years

What is being measured

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

Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3
The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints).
Measured: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)
Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation
The severity of nervousness/restlessness was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).
Measured: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)
Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation
The severity of irritability/eccentricity was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).
Measured: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)
Tolerability After Visit 2 and Visit 3
Assessment of tolerability at visit 2 and visit 3 well tolerated = no side effcts poor tolerated = side effects
Measured: appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)

Secondary outcomes (7)

Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration
The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints).
Decrease of the sumscore between baseline and last observation by concomitant medication (with and withour medication) and treatment duration (< 4 weeks and >= 4 weeks)
Measured: begin (visit 1) and last obvservation (could be appr. after 2 weeks (visit 2) or 4 weeks (visit 3))
Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication
The symptom nervousness/restlessnesswas analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0).
Measured: begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))
Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment
The symptom nervousness/restlessness was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0).
Measured: begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))
Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication
The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0).
Measured: begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))
Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment
The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0).
Measured: begin (visit 1) and last observation (appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))
Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no)
Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication.
The last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories "PASCONAL® better", "No difference" and "PASCONAL® worse".
Measured: appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)
Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration
Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication.
The last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories "PASCONAL® better", "No difference" and "PASCONAL® worse".
Measured: appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)

Timeline

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

May 2010Oct 2010

First posted18 May 2010 (estimated)
Study startMay 2010
Primary completionOct 2010
Study completionOct 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for NervousnessStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 325 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01125605
Sponsor's protocol ID: 174A10PNAL
Acronym: 174
Status last verified: Mar 2015
First submitted: 10 May 2010
Last updated: 14 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Nervousness trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PASCONAL NERVENTROPFEN in the Treatment of Adults and Children Suffering From Nervous Diseases (e.g. Sleep Disorders Due to Nervousness)
ClinicalTrials.gov ID: NCT01125605
Acronym / sponsor ID: 174 / 174A10PNAL
Conditions: Nervousness, Sleep Disorders
Keywords: PASCONAL, nervousness, nervosity, sleep disorder
Study type: Observational
Recruitment status: Completed
Enrolment: 325 participants (actual)
Lead sponsor: Pascoe Pharmazeutische Praeparate GmbHIndustry (pharma, biotech, devices)
Study start: May 2010
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 18 May 2010 (estimated)
Results: Posted 27 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this observational study is to give an overview of the use of PASCONAL NERVENTROPFEN in a 2-4 week treatment of nervous diseases, especially sleep disorders due to nervousness.

Detailed description

The purpose of this observational study is to give an overview of the use of PASCONAL NERVENTROPFEN in a 2-4 week treatment of nervous diseases, especially sleep disorders due to nervousness.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Adults > 12 years	–	–adult patients and patients older than 12 years
Children 6-12 years	–	–children between 6 and 12 years
Children 1-6 years	–	–children between 1 and 6 years

Who may qualify

Ages: 1 year and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Observational groups Patients (adults and children 1-12 years of age) suffering from nervous diseases, e.g. sleep-disturbances due to nervousness.

Key inclusion criteria (0 listed)

Key exclusion criteria (3 listed)

children younger than 1 year
no nervous diseases, e.g. sleep disorders due to nervousness.
no treatment with PASCONAL NERVENTROPFEN

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3
Time frame: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)
The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints).
Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation
Time frame: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)
The severity of nervousness/restlessness was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).
Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation
Time frame: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)
The severity of irritability/eccentricity was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).
Tolerability After Visit 2 and Visit 3
Time frame: appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)
Assessment of tolerability at visit 2 and visit 3 well tolerated = no side effcts poor tolerated = side effects

7 secondary outcomes

Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration
Time frame: begin (visit 1) and last obvservation (could be appr. after 2 weeks (visit 2) or 4 weeks (visit 3))
Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication
Time frame: begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))
Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment
Time frame: begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))
Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication
Time frame: begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))
Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment
Time frame: begin (visit 1) and last observation (appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))
Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no)
Time frame: appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)
Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration
Time frame: appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)

Results and safety

Results posted to the registry on 27 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Observational Group	325	325

Primary outcome: Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3

Time frame: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3). Mean (Standard Deviation). Unit: units on a scale

Measure	Visit 1 n = 325	Visit 2 n = 325	Visit 3 n = 309	Last Observation n = 325
Value	15.8 (6.1)	9.2 (5.6)	5.1 (4.5)	6.2 (5.2)

Population analysed: descriptive; for all partcipations with values at the visits

Primary outcome: Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation

Time frame: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3). Number. Unit: participants

Measure	Visit 1 n = 308	Visit 2 n = 306	Visit 3 n = 293	Last Observation n = 308
0=not present	0	23	78	79
1=mild	63	171	180	789
2=moderate	166	98	26	29
3=Strong	79	14	9	11

Population analysed: descriptive; for all partcipations with values at the visits

Primary outcome: Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation

Time frame: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3). Number. Unit: participants

Measure	Visit 1 n = 293	Visit 2 n = 291	Visit 3 n = 278	Last Observation n = 293
0=not present	0	41	111	115
1=mild	86	163	136	142
2=moderate	140	72	25	27
3=Strong	67	15	6	9

Population analysed: descriptive; for all partcipations with values at the visits

Primary outcome: Tolerability After Visit 2 and Visit 3

Time frame: appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3). Number. Unit: participants

Measure	Visit 2 n = 326	Visit 3 n = 326
well tolerated	313	303
poor tolerated	13	23

Population analysed: descriptive; for safety 326 patients were analysed; 1 patient had no efficacy values and were not analysed for efficacy; so a discrepancy between 325 patients (for efficacy) and 326 (for safety) occured

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: after appr. 2 weeks and after appr. 4 weeks. Other adverse events reported at 0.1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Observational Group	0 of 326 (0%)	14 of 326 (4.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Nervousness

Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingPhase 2
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ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bianka Krick study director

Pascoe Pharmazeutische Praeparate GmbH

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Nervousness and Sleep Disorders, run by Pascoe Pharmazeutische Praeparate GmbH at 1 site in Germany.

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 0 inclusion and 3 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 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

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 27 Aug 2012). 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?

Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3 (time frame: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)). The study lists 4 primary outcomes in all. 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 NCT01125605.

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 14 Apr 2015.