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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease
Idiopathic Parkinson's Disease

Study Design

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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

Groups and Cohorts

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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.

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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).
2. 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).
3. 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).
4. 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.

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

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.

Criteria

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

UCB Pharma GmbH

Investigators

Study Director:	UCB Clinical Trial Call Center	+1 877 822 9493 (UCB)

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

FDA Safety Alerts and Recalls 

Publications of Results:

Timmermann L, Oehlwein C, Ransmayr G, Fröhlich 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.

Responsible Party:	UCB Pharma GmbH
ClinicalTrials.gov Identifier:	NCT01606670 History of Changes
Other Study ID Numbers:	SP1058
First Posted:	May 28, 2012
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