Clinical trial NCT01159691: Change in Gastrointestinal Complaints After Switch From Oral Parkinson's Disease Treatment to Neupro® Transdermal Patch
Official title: A Multicentric, Non-interventional Study on Switching From Oral Parkinson Therapy to Neupro® in Patients With Idiopathic Parkinson's Disease With Gastrointestinal Symptoms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Parkinson's Disease
Keywords: Rotigotine
Neupro®
Parkinson's disease
Gastrointestinal
Switch from oral therapy to patch
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2010-07-09
Enrollment: 76
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 Parkinson's Disease (PD) suffering from gastrointestinal complaints under oral anti-parkinson treatment; treated in Germany by neurological outpatient centers (clinic/ practice of neurologist).

Brief summary: The study intends to collect data on gastrointestinal symptoms (swallowing disorders, heartburn, feeling of fullness, nausea, vomiting, abdominal pain, diarrhea) and on patient satisfaction under everyday practice conditions after changing treatment to Neupro® transdermal patch in patients suffering from idiopathic Parkinson´s Disease with gastrointestinal symptoms while being treated with oral antiparkinson drugs. The objective of the study is to ascertain whether switching therapy to Neupro® transdermal patch can provide any relief in gastrointestinal symptoms.

Detailed description: Routine treatment as per approved label in Europe in accordance with the terms of the local marketing authorization for Neupro®.

Eligibility criteria: Inclusion Criteria:

* The decision to prescribe Neupro® must have been made by the physician before and independently of his/her decision to include the patient in the study
* The patient's treatment must be in accordance with the terms of the local marketing authorization (MA) for Neupro®
* The patient must have a diagnosis of Idiopathic Parkinson's disease
* The patient must have signed the Consent form regarding study information, data transfer and use
* Patient suffering from gastrointestinal symptoms while being treated with oral Parkinson's medication

Exclusion Criteria:

Not applicable

Primary outcomes:
measure: Change From Baseline to Visit 3 in the Assessment of Intensity of Gastrointestinal (GI) Complaints for Any Reason as Per Visual Analogue Scale (VAS)
timeFrame: From Baseline to Visit 3 (approximately 6 weeks)
measure: Change From Baseline to Visit 3 in the Sum Score of Gastrointestinal (GI) Complaints
timeFrame: From Baseline to Visit 3 (approximately 6 weeks)
measure: Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2
timeFrame: At Visit 2 (after approximately 2-4 weeks)
measure: Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3
timeFrame: At Visit 3 (after approximately 6 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: 02
city: Bochum
country: Germany
facility: 24
city: Buchholz
country: Germany
facility: 38
city: Erbach
country: Germany
facility: 30
city: Gera
country: Germany
facility: 14
city: Goettingen
country: Germany
facility: 28
city: Karlstadt
country: Germany
facility: 16
city: Köln
country: Germany
facility: 7
city: Lauf an der Pegnitz
country: Germany
facility: 40
city: Lüneburg
country: Germany
facility: 39
city: München
country: Germany
facility: 37
city: Neuburg
country: Germany
facility: 31
city: Nürnberg
country: Germany
facility: 35
city: Schriesheim
country: Germany
facility: 22
city: Schwäbisch Gmünd
country: Germany
facility: 34
city: Stadtroda
country: Germany
facility: 21
city: Stuttgart
country: Germany
facility: 12
city: Stuttgart
country: Germany
facility: 36
city: Ulm
country: Germany
facility: 1
city: Ulm
country: Germany
facility: 32
city: Wolfratshausen
country: Germany
facility: 29
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Woitalla D, Kassubek J, Timmermann L, Lauterbach T, Berkels R, Grieger F, Muller T. Reduction of gastrointestinal symptoms in Parkinson's disease after a switch from oral therapy to rotigotine transdermal patch: a non-interventional prospective multicenter trial. Parkinsonism Relat Disord. 2015 Mar;21(3):199-204. doi: 10.1016/j.parkreldis.2014.11.024. Epub 2014 Dec 4.