Idiopathic Parkinson's DiseaseNON-GINCT01159691

Change in Gastrointestinal Complaints After Switch From Oral Parkinson's Disease Treatment to Neupro® Transdermal Patch

An observational study of Idiopathic Parkinson's Disease, run by UCB Pharma GmbH at 21 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Idiopathic Parkinson's Disease
How many people: 76 participants
Where: 21 sitesGermany
Study dates: Jun 2010to Mar 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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).

Who may be able to join

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

Who cannot join

Not applicable

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

Germany21 sites

02
Berlin
24
Bochum
38
Buchholz
7
Cologne
30
Erbach im Odenwald
14
Gera
28
Göttingen
16
Karlstadt am Main
40
Lauf an der Pegnitz
39
Lüneburg
37
München
31
Neuburg am Inn
35
Nuremberg
22
Schriesheim
34
Schwäbisch Gmünd
21
Stadtroda
12
Stuttgart
36
Stuttgart
1
Ulm
32
Ulm
29
Wolfratshausen

Other trials in Germany

About this study

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

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.

Read the detailed description

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

Conditions: Idiopathic Parkinson's Disease
Keywords: Rotigotine, Neupro®, Parkinson's disease, Gastrointestinal, Switch from oral therapy to patch
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01159691
Study group	Role	What they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Visit 3 (after approximately 6 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Mar 2012

First posted9 Jul 2010 (estimated)
Study startJun 2010
Primary completionMar 2012
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Idiopathic Parkinson's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01159691
Sponsor's protocol ID: SP0970
Acronym: NON-GI
Status last verified: May 2013
First submitted: 8 Jul 2010
Last updated: 21 May 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 25595315

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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MediPD: An Online Mediterranean Diet Program for People Living With Parkinson's Disease
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All Idiopathic Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01159691
Acronym / sponsor ID: NON-GI / SP0970
Conditions: Idiopathic Parkinson's Disease
Keywords: Rotigotine, Neupro®, Parkinson's disease, Gastrointestinal, Switch from oral therapy to patch
Study type: Observational
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: UCB Pharma GmbHIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 9 Jul 2010 (estimated)
Results: Posted 23 Apr 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

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

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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).

Key inclusion criteria (5 listed)

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

Key exclusion criteria (1 listed)

Not applicable

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Change From Baseline to Visit 3 in the Assessment of Intensity of Gastrointestinal (GI) Complaints for Any Reason as Per Visual Analogue Scale (VAS)
Time frame: From Baseline to Visit 3 (approximately 6 weeks)
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.
Change From Baseline to Visit 3 in the Sum Score of Gastrointestinal (GI) Complaints
Time frame: From Baseline to Visit 3 (approximately 6 weeks)
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.
Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2
Time frame: At Visit 2 (after approximately 2-4 weeks)
Patient satisfaction referring to GI complaints is classified into 5 categories: * Missing * Very satisfied * Satisfied * Moderately satisfied * Not satisfied.
Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3
Time frame: At Visit 3 (after approximately 6 weeks)
Patient satisfaction referring to GI complaints is classified into 5 categories: * Missing * Very satisfied * Satisfied * Moderately satisfied * Not satisfied.

Results and safety

Results posted to the registry on 23 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Neupro	76	54

Primary outcome: Change From Baseline to Visit 3 in the Assessment of Intensity of Gastrointestinal (GI) Complaints for Any Reason as Per Visual Analogue Scale (VAS)

Time frame: From Baseline to Visit 3 (approximately 6 weeks). Mean (Standard Deviation). Unit: millimeter (mm)

Measure	Neupro n = 58
Value	-26.8 (28.8)

Population analysed: Of the 65 subjects in the Full Analysis Set, 58 are included in this analysis.

Primary outcome: Change From Baseline to Visit 3 in the Sum Score of Gastrointestinal (GI) Complaints

Time frame: From Baseline to Visit 3 (approximately 6 weeks). Mean (Standard Deviation). Unit: units on a scale

Measure	Neupro n = 58
Value	-8.4 (8.1)

Population analysed: Of the 65 subjects in the Full Analysis Set, 58 are included in this analysis.

Primary outcome: Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2

Time frame: At Visit 2 (after approximately 2-4 weeks). Number. Unit: participants

Measure	Neupro n = 65
Missing	1
Very satisfied	25
Satisfied	26
Moderately satisfied	8
Not satisfied	5

Population analysed: All of the 65 subjects in the Full Analysis Set are included in this analysis.

Primary outcome: Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3

Time frame: At Visit 3 (after approximately 6 weeks). Number. Unit: participants

Measure	Neupro n = 65
Missing	7
Very satisfied	28
Satisfied	22
Moderately satisfied	6
Not satisfied	2

Population analysed: All of the 65 subjects in the Full Analysis Set are included in this analysis.

Adverse events

Time frame: Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Neupro	4 of 75 (5.3%)	21 of 75 (28%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25595315Woitalla 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.
Product InformationLink provided by the sponsor.
FDA Safety Alerts and RecallsLink provided by the sponsor.

Related trials for Idiopathic Parkinson's Disease

Not yet recruitingObservational study
Longitudinal Observation of Neurodegeneration in Parkinson's Disease Using Molecular Imaging and Blood Biomarkers
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Ginger-PD: Ginger as a Modifier of Ghrelin Levels and Gut Function in Parkinson's Disease
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

UCB Clinical Trial Call Center study director

+1 877 822 9493 (UCB)

21 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Idiopathic Parkinson's Disease, run by UCB Pharma GmbH at 21 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: From Baseline to Visit 3 (approximately 6 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01159691, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2013.