Observational Study With Neupro® to Evaluate the Patient´s Perception of Pain Associated With Parkinson´s Disease (NEUPAD)
This study has been completed.
Sponsor:
UCB Pharma GmbH
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
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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 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
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 March 03, 2015