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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma GmbH )
ClinicalTrials.gov Identifier:
NCT01606670
First received: May 22, 2012
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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
Idiopathic Parkinson's Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • 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®) ] [ Designated as safety issue: No ]

    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 is obtained with the highest possible score being 12. Values above 8 can be considered noticeable.



Secondary Outcome Measures:
  • 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®) ] [ Designated as safety issue: No ]
    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®) ] [ Designated as safety issue: No ]
    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®) ] [ Designated as safety issue: No ]
    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®) ] [ Designated as safety issue: No ]
    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, if applicable]).


Enrollment: 93
Study Start Date: May 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01606670

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

Additional Information:
No publications provided

Responsible Party: UCB Pharma ( UCB Pharma GmbH )
ClinicalTrials.gov Identifier: NCT01606670     History of Changes
Other Study ID Numbers: SP1058
Study First Received: May 22, 2012
Last Updated: July 7, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Federal Office for Safety in Health Care

Keywords provided by UCB Pharma:
Rotigotine
Neupro®

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on October 20, 2014