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

This study is currently recruiting participants.
Verified April 2014 by UCB, Inc.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc. ( UCB Pharma GmbH )
ClinicalTrials.gov Identifier:
NCT01606670
First received: May 22, 2012
Last updated: April 8, 2014
Last verified: April 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, Inc.:

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]).


Estimated Enrollment: 90
Study Start Date: May 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01606670

Contacts
Contact: UCB Clinical Trial Call Center +1 877 822 9493

  Show 50 Study Locations
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, Inc. ( UCB Pharma GmbH )
ClinicalTrials.gov Identifier: NCT01606670     History of Changes
Other Study ID Numbers: SP1058
Study First Received: May 22, 2012
Last Updated: April 8, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Federal Office for Safety in Health Care

Keywords provided by UCB, Inc.:
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
N 0437
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014