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 May 2013 by UCB, Inc.
Sponsor:
UCB Pharma GmbH
Information provided by (Responsible Party):
UCB, Inc. ( UCB Pharma GmbH )
ClinicalTrials.gov Identifier:
NCT01606670
First received: May 22, 2012
Last updated: May 10, 2013
Last verified: May 2013
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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:
MedlinePlus related topics:
Parkinson's Disease
Drug Information available for:
Rotigotine
U.S. FDA Resources
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: | 150 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 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 |
Locations
| Germany | |
| 40 | Recruiting |
| Achim, Germany | |
| 16 | Recruiting |
| Altenholz, Germany | |
| 5 | Recruiting |
| Alzenau, Germany | |
| 22 | Recruiting |
| Bad Honnef, Germany | |
| 26 | Recruiting |
| Bad Krozingen, Germany | |
| 10 | Recruiting |
| Berlin, Germany | |
| 27 | Recruiting |
| Berlin, Germany | |
| 14 | Recruiting |
| Bielefeld, Germany | |
| 9 | Recruiting |
| Bochum, Germany | |
| 23 | Recruiting |
| Bremerhaven, Germany | |
| 4 | Recruiting |
| Dresden, Germany | |
| 34 | Recruiting |
| Düsseldorf, Germany | |
| 38 | Recruiting |
| Erbach, Germany | |
| 24 | Recruiting |
| Freiburg, Germany | |
| 1 | Recruiting |
| Gera, Germany | |
| 3 | Recruiting |
| Goettingen, Germany | |
| 32 | Recruiting |
| Hamburg, Germany | |
| 19 | Recruiting |
| Hannover, Germany | |
| 2 | Recruiting |
| Heidenheim, Germany | |
| 36 | Recruiting |
| Jena, Germany | |
| 21 | Recruiting |
| Kastellaun, Germany | |
| 11 | Recruiting |
| Konigsbruck, Germany | |
| 20 | Recruiting |
| Köln, Germany | |
| 17 | Withdrawn |
| Lohr, Germany | |
| 15 | Recruiting |
| Mühldorf am Inn, Germany | |
| 18 | Withdrawn |
| München, Germany | |
| 28 | Recruiting |
| München, Germany | |
| 33 | Recruiting |
| Münster, Germany | |
| 6 | Recruiting |
| Oldenburg, Germany | |
| 30 | Recruiting |
| Osnabrück, Germany | |
| 35 | Recruiting |
| Osnabrück, Germany | |
| 39 | Recruiting |
| Remscheid, Germany | |
| 31 | Recruiting |
| Ruesselsheim, Germany | |
| 7 | Recruiting |
| Schriesheim, Germany | |
| 29 | Recruiting |
| Schwendi, Germany | |
| 12 | Recruiting |
| Stadtroda, Germany | |
| 8 | Recruiting |
| Stuttgart, Germany | |
| 13 | Recruiting |
| Ulm, Germany | |
| 41 | Recruiting |
| Westerstede, Germany | |
| 37 | Recruiting |
| 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, Inc. ( UCB Pharma GmbH ) |
| ClinicalTrials.gov Identifier: | NCT01606670 History of Changes |
| Other Study ID Numbers: | SP1058 |
| Study First Received: | May 22, 2012 |
| Last Updated: | May 10, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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 May 21, 2013