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

Completed

• Conditions: Idiopathic Parkinson's Disease

• Registration Number: NCT01606670
• Lead Sponsor: UCB Pharma GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-22
• Study First Submitted QC: 2012-05-23
• Study First Posted: 2012-05-28
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Results First Submitted: 2015-04-01
• Results First Submitted QC: 2015-04-28
• Results First Posted: 2015-04-29
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-09
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
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®)	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 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®)	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 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®)	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.
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®)	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).

Trial Locations

Locations (27)

5; 🇩🇪 Alzenau, Germany

16; 🇩🇪 Altenholz, Germany

22; 🇩🇪 Bad Honnef, Germany

26; 🇩🇪 Bad Krozingen, Germany

10; 🇩🇪 Berlin, Germany

4; 🇩🇪 Dresden, Germany

38; 🇩🇪 Erbach, Germany

34; 🇩🇪 Düsseldorf, 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

35; 🇩🇪 Osnabrück, Germany

33; 🇩🇪 Münster, Germany

7; 🇩🇪 Schriesheim, Germany

31; 🇩🇪 Ruesselsheim, Germany

44; 🇩🇪 Senftenberg, Germany

12; 🇩🇪 Stadtroda, Germany

41; 🇩🇪 Westerstede, Germany

13; 🇩🇪 Ulm, Germany

37; 🇩🇪 Würzburg, Germany

61; 🇦🇹 Feldbach, Austria

60; 🇦🇹 Linz, Austria