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

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ClinicalTrials.gov Identifier: NCT01606670
Recruitment Status : Completed
First Posted : May 28, 2012
Results First Posted : April 29, 2015
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma GmbH )

Study Description
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Rotigotine

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, Older Adult
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Additional Information:
FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

Publications of Results:

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