Observational Study With Neupro® to Evaluate the Patient´s Perception of Pain Associated With Parkinson´s Disease (NEUPAD)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01606670 |
Recruitment Status
:
Completed
First Posted
: May 28, 2012
Results First Posted
: April 29, 2015
Last Update Posted
: April 4, 2018
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Idiopathic Parkinson's Disease |
Study Type : | Observational |
Actual Enrollment : | 93 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Multicenter, Non-interventional Study With Neupro® to Evaluate the Perception of Pain Associated With Idiopathic Parkinson's Disease |
Study Start Date : | May 2012 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | July 2014 |

Group/Cohort |
---|
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.
|
- 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.
- 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®) ]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).
- 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®) ]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).
- 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®) ]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).
- 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®) ]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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606670
Austria | |
61 | |
Feldbach, Austria | |
60 | |
Linz, Austria | |
Germany | |
16 | |
Altenholz, Germany | |
5 | |
Alzenau, Germany | |
22 | |
Bad Honnef, Germany | |
26 | |
Bad Krozingen, Germany | |
10 | |
Berlin, Germany | |
4 | |
Dresden, Germany | |
34 | |
Düsseldorf, Germany | |
38 | |
Erbach, Germany | |
24 | |
Freiburg, Germany | |
1 | |
Gera, Germany | |
3 | |
Goettingen, Germany | |
32 | |
Hamburg, Germany | |
2 | |
Heidenheim, Germany | |
11 | |
Konigsbruck, Germany | |
20 | |
Köln, Germany | |
15 | |
Mühldorf Am Inn, Germany | |
33 | |
Münster, Germany | |
35 | |
Osnabrück, Germany | |
31 | |
Ruesselsheim, Germany | |
7 | |
Schriesheim, Germany | |
44 | |
Senftenberg, Germany | |
12 | |
Stadtroda, Germany | |
13 | |
Ulm, Germany | |
41 | |
Westerstede, Germany | |
37 | |
Würzburg, Germany |
Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
Additional Information:
Publications of Results:
Responsible Party: | UCB Pharma GmbH |
ClinicalTrials.gov Identifier: | NCT01606670 History of Changes |
Other Study ID Numbers: |
SP1058 |
First Posted: | May 28, 2012 Key Record Dates |
Results First Posted: | April 29, 2015 |
Last Update Posted: | April 4, 2018 |
Last Verified: | March 2018 |
Keywords provided by UCB Pharma ( UCB Pharma GmbH ):
Rotigotine Neupro® |
Additional relevant MeSH terms:
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders |
Neurodegenerative Diseases Rotigotine Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |