Observational Study With Neupro® to Evaluate the Patient´s Perception of Pain Associated With Parkinson´s Disease
NEUPAD
A Multicenter, Non-interventional Study With Neupro® to Evaluate the Perception of Pain Associated With Idiopathic Parkinson's Disease
1 other identifier
observational
93
2 countries
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2012
Typical duration for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 22, 2012
CompletedFirst Posted
Study publicly available on registry
May 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
April 29, 2015
CompletedApril 4, 2018
March 1, 2018
2.2 years
May 22, 2012
April 1, 2015
March 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
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.
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
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
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
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
From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)
Study Arms (1)
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.
Eligibility Criteria
Patients with pain associated with idiopathic Parkinson´s Disease. Every consecutive, eligible patient to be treated with Neupro® as per physician's decision.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharma GmbHlead
Study Sites (27)
61
Feldbach, Austria
60
Linz, Austria
16
Altenholz, Germany
5
Alzenau in Unterfranken, Germany
22
Bad Honnef, Germany
26
Bad Krozingen, Germany
10
Berlin, Germany
20
Cologne, Germany
4
Dresden, Germany
34
Düsseldorf, Germany
38
Erbach im Odenwald, Germany
24
Freiburg im Breisgau, Germany
1
Gera, Germany
3
Göttingen, Germany
32
Hamburg, Germany
2
Heidenheim, Germany
11
Königsbrück, Germany
15
Mühldorf, Germany
33
Münster, Germany
35
Osnabrück, Germany
31
Rüsselsheim am Main, Germany
7
Schriesheim, Germany
44
Senftenberg, Germany
12
Stadtroda, Germany
13
Ulm, Germany
41
Westerstede, Germany
37
Würzburg, Germany
Related Publications (1)
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.
PMID: 27883297RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2012
First Posted
May 28, 2012
Study Start
May 1, 2012
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
April 4, 2018
Results First Posted
April 29, 2015
Record last verified: 2018-03