Idiopathic Parkinson's DiseaseNEUPADNCT01606670

Observational Study With Neupro® to Evaluate the Patient´s Perception of Pain Associated With Parkinson´s Disease

An observational study of Idiopathic Parkinson's Disease, run by UCB Pharma GmbH at 27 sites in 2 countries.

Completed

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

Trial summary

The primary objective of this study is to evaluate the perception of pain associated with Parkinson´s Disease in patients who receive Neupro® for the first time. Read more about this study

Who is it for?: Any age
Conditions the study is for: Idiopathic Parkinson's Disease
How many people: 93 participants
Where: 27 sitesin 2 countries
Study dates: May 2012to Jul 2014
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients with pain associated with idiopathic Parkinson´s Disease. Every consecutive, eligible patient to be treated with Neupro® as per physician's decision.

Who may be able to join

The decision by the treating physician to treat a patient with Neupro® for the first time is made before the patient's participation in this Non-Interventional Study (NIS)
A Patient Data Consent form is signed and dated by the patient
Male and female patients that suffer from pain associated with idiopathic Parkinson's Disease according to the physician's assessment
Patients have not been treated with Rotigotine in the past

Who cannot join

None listed.

Trial locations and contacts

27 sites in 2 countries.

Country

City, postcode or hospital

27 sites in 2 countries

Germany25 sites

16
Altenholz
5
Alzenau in Unterfranken
22
Bad Honnef
26
Bad Krozingen
10
Berlin
20
Cologne
4
Dresden
34
Düsseldorf
38
Erbach im Odenwald
24
Freiburg im Breisgau
1
Gera
3
Göttingen
32
Hamburg
2
Heidenheim
11
Königsbrück
15
Mühldorf
33
Münster
35
Osnabrück
31
Rüsselsheim am Main
7
Schriesheim
44
Senftenberg
12
Stadtroda
13
Ulm
41
Westerstede
37
Würzburg

Other trials in Germany

Austria2 sites

61
Feldbach
60
Linz

Other trials in Austria

About this study

Official title: A Multicenter, Non-interventional Study With Neupro® to Evaluate the Perception of Pain Associated With Idiopathic Parkinson's Disease

The primary objective of this study is to evaluate the perception of pain associated with Parkinson´s Disease in patients who receive Neupro® for the first time.

Conditions: Idiopathic Parkinson's Disease
Keywords: Rotigotine, Neupro®
Medical subject headings: Parkinson Disease

What participants receive

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

Study groups in NCT01606670
Study group	Role	What they receive
Neupro® Treatment		Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member state Germany.

What is being measured

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

Change From Baseline to Visit 2 in the Sum Score Calculated From the 4 Items of the Affective Dimension of the Pain Description List (Schmerzbeschreibungsliste SBL, Question 10) of the German Pain Questionnaire
The Pain Description List (SBL, question 10) is part of the validated German Pain Questionnaire (DSF).
The SBL consists of a 12 item list of adjectives. Each adjective is ranked from 0 (not applicable) to 3 (exactly applicable).
8 of the 12 adjectives will be used to assess the sensory items of pain and 4 adjectives to describe the affective items of pain.
The 8 sensory items are used to assess qualitative description of pain. For the 4 affective pain items, a sum score ranges from 0 (not applicable) to 12 (exactly applicable). Values above 8 can be considered noticeable.
Measured: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)

Secondary outcomes (4)

Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II
The UPDRS is a scale for the assessment of function in Parkinson's disease. Part II measures 'Activities of Daily Living'. It consists of 13 questions, each ranging from 0 (none) to 4 (severe abnormalities). The sum score of the UPDRS Part II ranges from 0 (normal) to 52 (worst score possible).
Measured: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)
Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part III
The UPDRS is a scale for the assessment of function in Parkinson's disease. Part III measures 'Motor Function'. It consists of 14 items with 27 questions, each ranging from 0 (normal) to 4 (severe abnormalities). The sum score of the UPDRS Part III ranges from 0 (normal) to 108 (worst score possible).
Measured: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)
Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III
The UPDRS is a scale for the assessment of function in Parkinson's disease. Part II measures 'Activities of Daily Living' and Part III 'Motor Function'. They consist of 40 questions, each ranging from 0 (normal) to 4 (severe abnormalities). The sum score of the UPDRS Part II+III ranges from 0 (normal) to 160 (worst score possible).
Measured: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)
Change From Baseline to Visit 2 in the Short-form Parkinson's Disease Questionnaire (PDQ-8) Total Score
The PDQ-8 is a self-administered 8 item questionnaire that assesses the overall health status. The questions will be rated from 0 (never) to 4 (always [or cannot do at all]). The total score ranges from 0 (never) to 32 (always [or cannot do at all]) with lower scores indicating a better health status.
Measured: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)

Timeline

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

May 2012Jul 2014

First posted28 May 2012 (estimated)
Study startMay 2012
Primary completionJul 2014
Study completionJul 2014

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Idiopathic Parkinson's DiseaseStudies 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: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01606670
Sponsor's protocol ID: SP1058
Acronym: NEUPAD
Status last verified: Mar 2018
First submitted: 22 May 2012
Last updated: 4 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Timmermann L, Oehlwein C, Ransmayr G, Frohlich H, Will E, Schroeder H, Lauterbach T, Bauer L, Kassubek J. Patients' perception of Parkinson's disease-associated pain following initiation of rotigotine: a multicenter non-interventional study. Postgrad Med. 2017 Jan;129(1):46-54. doi: 10.1080/00325481.2017.1258953. Epub 2016 Nov 24.
PubMed 27883297

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 Idiopathic Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Non-interventional Study With Neupro® to Evaluate the Perception of Pain Associated With Idiopathic Parkinson's Disease
ClinicalTrials.gov ID: NCT01606670
Acronym / sponsor ID: NEUPAD / SP1058
Conditions: Idiopathic Parkinson's Disease
Keywords: Rotigotine, Neupro®
Study type: Observational
Recruitment status: Completed
Enrolment: 93 participants (actual)
Lead sponsor: UCB Pharma GmbHIndustry (pharma, biotech, devices)
Study start: May 2012
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 28 May 2012 (estimated)
Results: Posted 29 Apr 2015

Clinical summary

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

The primary objective of this study is to evaluate the perception of pain associated with Parkinson´s Disease in patients who receive Neupro® for the first time.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Neupro® Treatment	–	–Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member state Germany.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with pain associated with idiopathic Parkinson´s Disease. Every consecutive, eligible patient to be treated with Neupro® as per physician's decision.

Key inclusion criteria (4 listed)

The decision by the treating physician to treat a patient with Neupro® for the first time is made before the patient's participation in this Non-Interventional Study (NIS)
A Patient Data Consent form is signed and dated by the patient
Male and female patients that suffer from pain associated with idiopathic Parkinson's Disease according to the physician's assessment
Patients have not been treated with Rotigotine in the past

Key exclusion criteria (0 listed)

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

Change From Baseline to Visit 2 in the Sum Score Calculated From the 4 Items of the Affective Dimension of the Pain Description List (Schmerzbeschreibungsliste SBL, Question 10) of the German Pain Questionnaire
Time frame: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)
The Pain Description List (SBL, question 10) is part of the validated German Pain Questionnaire (DSF). The SBL consists of a 12 item list of adjectives. Each adjective is ranked from 0 (not applicable) to 3 (exactly applicable). 8 of the 12 adjectives will be used to assess the sensory items of pain and 4 adjectives to describe the affective items of pain. The 8 sensory items are used to assess qualitative description of pain. For the 4 affective pain items, a sum score ranges from 0 (not applicable) to 12 (exactly applicable). Values above 8 can be considered noticeable.

4 secondary outcomes

Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II
Time frame: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)
Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part III
Time frame: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)
Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III
Time frame: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)
Change From Baseline to Visit 2 in the Short-form Parkinson's Disease Questionnaire (PDQ-8) Total Score
Time frame: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)

Results and safety

Results posted to the registry on 29 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Neupro® Treatment	93	77

Primary outcome: Change From Baseline to Visit 2 in the Sum Score Calculated From the 4 Items of the Affective Dimension of the Pain Description List (Schmerzbeschreibungsliste SBL, Question 10) of the German Pain Questionnaire

Time frame: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®). Mean (Standard Deviation). Unit: units on a scale

Measure	Neupro® Treatment n = 70
Value	-1.3 (2.8)

Population analysed: Full Analysis Set (FAS). The FAS includes all enrolled patients who had applied the rotigotine transdermal patch at least once and for whom valid data for the primary effectiveness variable were available from Baseline and a subsequent routine visit.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected over the whole study from Visit 1 (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Neupro® Treatment	0 of 93 (0%)	10 of 93 (10.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27883297Timmermann L, Oehlwein C, Ransmayr G, Frohlich H, Will E, Schroeder H, Lauterbach T, Bauer L, Kassubek J. Patients' perception of Parkinson's disease-associated pain following initiation of rotigotine: a multicenter non-interventional study. Postgrad Med. 2017 Jan;129(1):46-54. doi: 10.1080/00325481.2017.1258953. Epub 2016 Nov 24.
Product InformationLink provided by the sponsor.
FDA Safety Alerts and RecallsLink provided by the sponsor.

Related trials for Idiopathic Parkinson's Disease

RecruitingPhase 2
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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.

UCB Clinical Trial Call Center study director

+1 877 822 9493 (UCB)

27 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Idiopathic Parkinson's Disease, run by UCB Pharma GmbH at 27 sites in 2 countries.

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 4 inclusion and 0 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 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Germany, Austria. 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 29 Apr 2015). 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 From Baseline to Visit 2 in the Sum Score Calculated From the 4 Items of the Affective Dimension of the Pain Description List (Schmerzbeschreibungsliste SBL, Question 10) of the German Pain Questionnaire (time frame: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)). 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 NCT01606670, which also lists 1 linked publication.

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 4 Apr 2018; AzTrials last refreshed its copy on 31 Oct 2026.