Clinical trial NCT01606670: Observational Study With Neupro® to Evaluate the Patient´s Perception of Pain Associated With Parkinson´s Disease
Official title: A Multicenter, Non-interventional Study With Neupro® to Evaluate the Perception of Pain Associated With Idiopathic Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Parkinson's Disease
Keywords: Rotigotine
Neupro®
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2012-05-28
Enrollment: 93
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: 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
timeFrame: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)
Secondary outcomes:
measure: Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II
timeFrame: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)
measure: Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part III
timeFrame: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)
measure: Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III
timeFrame: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)
measure: Change From Baseline to Visit 2 in the Short-form Parkinson's Disease Questionnaire (PDQ-8) Total Score
timeFrame: From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)
Other outcomes:
Locations:
city: Feldbach
country: Austria
facility: 61
city: Linz
country: Austria
facility: 60
city: Altenholz
country: Germany
facility: 16
city: Alzenau
country: Germany
facility: 5
city: Bad Honnef
country: Germany
facility: 22
city: Bad Krozingen
country: Germany
facility: 26
city: Berlin
country: Germany
facility: 10
city: Dresden
country: Germany
facility: 4
city: Düsseldorf
country: Germany
facility: 34
city: Erbach
country: Germany
facility: 38
city: Freiburg
country: Germany
facility: 24
city: Gera
country: Germany
facility: 1
city: Goettingen
country: Germany
facility: 3
city: Hamburg
country: Germany
facility: 32
city: Heidenheim
country: Germany
facility: 2
city: Konigsbruck
country: Germany
facility: 11
city: Köln
country: Germany
facility: 20
city: Mühldorf Am Inn
country: Germany
facility: 15
city: Münster
country: Germany
facility: 33
city: Osnabrück
country: Germany
facility: 35
city: Ruesselsheim
country: Germany
facility: 31
city: Schriesheim
country: Germany
facility: 7
city: Senftenberg
country: Germany
facility: 44
city: Stadtroda
country: Germany
facility: 12
city: Ulm
country: Germany
facility: 13
city: Westerstede
country: Germany
facility: 41
city: Würzburg
country: Germany
facility: 37
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Timmermann L, Oehlwein C, Ransmayr G, Frohlich H, Will E, Schroeder H, Lauterbach T, Bauer L, Kassubek J. Patients' perception of Parkinson's disease-associated pain following initiation of rotigotine: a multicenter non-interventional study. Postgrad Med. 2017 Jan;129(1):46-54. doi: 10.1080/00325481.2017.1258953. Epub 2016 Nov 24.