N/A
N=93
Observational Study With Neupro® to Evaluate the Patient´s Perception of Pain Associated With Parkinson´s Disease
Idiopathic Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01606670 ↗Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: 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 — -1.3 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- UCB Pharma GmbH
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-1.3 | — |
| SECONDARY Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II |
-1.3 | — |
| SECONDARY Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part III |
-3.9 | — |
| SECONDARY Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III |
-5.3 | — |
| SECONDARY Change From Baseline to Visit 2 in the Short-form Parkinson's Disease Questionnaire (PDQ-8) Total Score |
-2.0 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01606670). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.