Change in Gastrointestinal Complaints After Switch From Oral Parkinson's Disease Treatment to Neupro® Transdermal Patch (NON-GI)

A Multicentric, Non-interventional Study on Switching From Oral Parkinson Therapy to Neupro® in Patients With Idiopathic Parkinson's Disease With Gastrointestinal Symptoms

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Parkinson's Disease

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • 02
  • Bochum, Germany
    • 24
  • Buchholz, Germany
    • 38
  • Erbach, Germany
    • 30
  • Gera, Germany
    • 14
  • Goettingen, Germany
    • 28
  • Karlstadt, Germany
    • 16
  • Köln, Germany
    • 7
  • Lauf an der Pegnitz, Germany
    • 40
  • Lüneburg, Germany
    • 39
  • München, Germany
    • 37
  • Neuburg, Germany
    • 31
  • Nürnberg, Germany
    • 35
  • Schriesheim, Germany
    • 22
  • Schwäbisch Gmünd, Germany
    • 34
  • Stadtroda, Germany
    • 21
  • Stuttgart, Germany
    • 12
  • Stuttgart, Germany
    • 36
  • Ulm, Germany
    • 1
  • Ulm, Germany
    • 32
  • Wolfratshausen, Germany
    • 29

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Neupro; Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Visit 3 in the Assessment of Intensity of Gastrointestinal (GI) Complaints for Any Reason as Per Visual Analogue Scale (VAS)	Patients were asked to classify the intensity of their GI complaints on a scale ranging from 0 (no complaints) to 100 (extremely severe complaints). Negative values indicate an improvement from Baseline to Visit 3 with larger negative values showing a better improvement.	From Baseline to Visit 3 (approximately 6 weeks)
Change From Baseline to Visit 3 in the Sum Score of Gastrointestinal (GI) Complaints	Sum score of GI complaints was calculated from frequency and intensity of the complaints. The intensity of GI complaints during the last week ranges from 0 (no complaints) to 3 (severe) and the frequency of these complaints during the last week ranges from 0 (never) to 4 (every day). For each of the seven GI complaints assessed at a visit (swallowing disorders, heartburn, feeling of fullness, nausea, vomiting, abdominal pain, and diarrhea), intensity and frequency were multiplied to achieve individual item scores of GI complaints (range: 0 - 12). Finally, the sum score of GI complaints per visit was calculated by accumulating 6 of the 7 item scores (excluding swallowing disorders, which was recorded at Baseline only) for patients with valid values in each score (range: 0 - 72). Negative values indicate an improvement from Baseline to Visit 3 with larger negative values showing a better improvement.	From Baseline to Visit 3 (approximately 6 weeks)
Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2	Patient satisfaction referring to GI complaints is classified into 5 categories: Missing; Very satisfied; Satisfied; Moderately satisfied; Not satisfied.	At Visit 2 (after approximately 2-4 weeks)
Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3	Patient satisfaction referring to GI complaints is classified into 5 categories: Missing; Very satisfied; Satisfied; Moderately satisfied; Not satisfied.	At Visit 3 (after approximately 6 weeks)

Collaborators and Investigators

• Sponsor: UCB Pharma GmbH

Publications and helpful links

General Publications

• 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.

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: July 8, 2010
• First Submitted That Met QC Criteria: July 8, 2010
• First Posted (Estimate): July 9, 2010

Study Record Updates

• Last Update Posted (Estimate): May 21, 2013
• Last Update Submitted That Met QC Criteria: May 13, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Rotigotine; Parkinson's disease; Gastrointestinal; Neupro®; Switch from oral therapy to patch
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: SP0970

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No