NCT01159691

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 23, 2013

Completed
Last Updated

May 21, 2013

Status Verified

May 1, 2013

Enrollment Period

1.8 years

First QC Date

July 8, 2010

Results QC Date

March 11, 2013

Last Update Submit

May 13, 2013

Conditions

Idiopathic Parkinson's Disease

Keywords

RotigotineNeupro®Parkinson's diseaseGastrointestinalSwitch from oral therapy to patch

Outcome Measures

Primary Outcomes (4)

  • 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)

Study Arms (1)

Neupro

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

02

Berlin, Germany

Location

24

Bochum, Germany

Location

38

Buchholz, Germany

Location

7

Cologne, Germany

Location

30

Erbach im Odenwald, Germany

Location

14

Gera, Germany

Location

28

Göttingen, Germany

Location

16

Karlstadt am Main, Germany

Location

40

Lauf an der Pegnitz, Germany

Location

39

Lüneburg, Germany

Location

37

München, Germany

Location

31

Neuburg am Inn, Germany

Location

35

Nuremberg, Germany

Location

22

Schriesheim, Germany

Location

34

Schwäbisch Gmünd, Germany

Location

21

Stadtroda, Germany

Location

12

Stuttgart, Germany

Location

36

Stuttgart, Germany

Location

1

Ulm, Germany

Location

32

Ulm, Germany

Location

29

Wolfratshausen, Germany

Location

Related Publications (1)

  • 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.

    PMID: 25595315DERIVED

Related Links

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Results Point of Contact

Title
UCB Clinical Trial Call Center
Organization
UCB
+1 877 822 9493 (UCB)

Study Officials

  • UCB Clinical Trial Call Center

    +1 877 822 9493 (UCB)

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2010

First Posted

July 9, 2010

Study Start

June 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

May 21, 2013

Results First Posted

April 23, 2013

Record last verified: 2013-05

Locations

DE(21)