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

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 Overview

• Status: Completed
• Conditions: Idiopathic Parkinson's Disease

• Study Type: Observational
• Enrollment (Actual): 93

Contacts and Locations

Study Locations

• Austria
  • Feldbach, Austria
    • 61
  • Linz, Austria
    • 60
• Germany
  • Altenholz, Germany
    • 16
  • Alzenau, Germany
    • 5
  • Bad Honnef, Germany
    • 22
  • Bad Krozingen, Germany
    • 26
  • Berlin, Germany
    • 10
  • Dresden, Germany
    • 4
  • Düsseldorf, Germany
    • 34
  • Erbach, Germany
    • 38
  • Freiburg, Germany
    • 24
  • Gera, Germany
    • 1
  • Goettingen, Germany
    • 3
  • Hamburg, Germany
    • 32
  • Heidenheim, Germany
    • 2
  • Konigsbruck, Germany
    • 11
  • Köln, Germany
    • 20
  • Mühldorf Am Inn, Germany
    • 15
  • Münster, Germany
    • 33
  • Osnabrück, Germany
    • 35
  • Ruesselsheim, Germany
    • 31
  • Schriesheim, Germany
    • 7
  • Senftenberg, Germany
    • 44
  • Stadtroda, Germany
    • 12
  • Ulm, Germany
    • 13
  • Westerstede, Germany
    • 41
  • Würzburg, Germany
    • 37

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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.	From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)

Collaborators and Investigators

• Sponsor: UCB Pharma GmbH

Publications and helpful links

General 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.

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: May 22, 2012
• First Submitted That Met QC Criteria: May 23, 2012
• First Posted (Estimate): May 28, 2012

Study Record Updates

• Last Update Posted (Actual): April 4, 2018
• Last Update Submitted That Met QC Criteria: March 9, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Rotigotine; Neupro®
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: SP1058