Idiopathic Parkinson's DiseaseCARE-ACTNCT01330290
Caregivers' and Physicians' Treatment Preference in Parkinson Patients Treated With Neupro® Requiring Caregiver Support
An observational study of Idiopathic Parkinson's Disease, run by UCB Pharma at 54 sites in Germany.
Trial summary
The study objective is to evaluate advantages and disadvantages of Neupro® versus oral anti-Parkinson medication by caregivers and physicians in idiopathic Parkinson's Disease patients requiring caregiver support in nursing home or outpatient care settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Parkinson's Disease
- What is being tested?
- Neupro®
- Type of treatment
- Pill or oral medicine
- How many people
- 148 participants
- Where
- 54 sitesGermany
- Study dates
- Mar 2011to Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Idiopathic Parkinson's Disease (iPD) patients treated with a combination of L-dopa or other oral iPD drug and Neupro® for at least one month and requiring caregiver support documented as per medical records Every consecutive, eligible patient to be treated with Neupro® as per physician's decision
Who may be able to join
- Only patients having signed the consent form regarding study information, data transfer and data use
- The patients suffer from idiopathic Parkinson's Disease (iPD) treated with a combination of L-dopa or another oral iPD drug and Neupro® for at least one month
- The patients require caregiver support documented as per medical records (e.g. based on German level of care intensity 1 or greater)
- The decision to prescribe Neupro® must have been made by the physician independent of his/her decision to include the patient in the study
Who cannot join
- Patients not fulfilling the inclusion criteria
- And according to Summary of Product Characteristics (SmPC): Hypersensitivity to the active substance or to any of the excipients, magnetic resonance tomography (MRT) or cardioversion
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
Germany54 sites
52
Abensberg
53
Alzenau in Unterfranken
18
Beelitz-Heilstätten
42
Bensheim
24
Berlin
27
Berlin
37
Celle
58
Cologne
17
Dillingen
48
Dresden
32
Eisenach
39
Erbach im Odenwald
43
Erfurt
60
Essen
5
Gelnhausen
40
Gelsenkirchen
31
Göttingen
38
Guelders
29
Hagen
57
Halle
6
Halle
28
Hamm
47
Hanover
7
Herborn
55
Hoppegarten
59
Jena
50
Karlstadt am Main
44
Königsbrück
51
Lappersdorf
8
Lohr
4
Marktheidenfeld
45
Merzig
36
Minden
34
Mittweida
35
Mühldorf
25
München
41
München
30
Münster
49
Neuburg am Inn
21
Neumarkt
13
Niederschöna
9
Oschatz
54
Schorndorf
2
Schriesheim
1
Stralsund
12
Stratroda
15
Stuttgard
33
Stuttgart
20
Ulm
14
Unterhaching
22
Weil am Rhein
11
Westerstede
23
Wolfach
56
Wolfratshausen
About this study
Official title: A Multi-site, Non-interventional, Cross-sectional Evaluation of the Caregivers' and the Physicians' Preferred Route of Administration and the Physicians' Rationale for the Choice of Neupro® in Patients With Parkinson Requiring Caregiver Support
The study objective is to evaluate advantages and disadvantages of Neupro® versus oral anti-Parkinson medication by caregivers and physicians in idiopathic Parkinson's Disease patients requiring caregiver support in nursing home or outpatient care settings.
- Conditions
- Idiopathic Parkinson's Disease
- Being tested
- Neupro®
- Keywords
- Rotigotine, Neupro®, Parkinson, Treatment preference, Care-giving
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neupro®Drug
Also called Rotigotine
Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed.
| Study group | Role | What they receive |
|---|---|---|
| Neupro® Treatment | Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro® Receives: Drug: Neupro® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Score of the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication
The caregivers were asked to fill out a questionnaire composed of 7 questions covering caregiving aspects. The mean score is calculated from the scores for the single responses which are rated from 'great disadvantages' to 'great advantages' and scored on a 5-point scale from -2 to +2.
Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers.
Measured: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Mean Score of the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication
The physicians were asked to fill out a questionnaire composed of 10 questions covering medical and caregiving aspects. The mean score is calculated from the scores for the single responses which are rated from 'great disadvantages' to 'great advantages' and scored on a 5-point scale from -2 to +2.
Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians.
Measured: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Secondary outcomes (19)
Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Substance in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support
The physician was asked if he / she prescribed Neupro® due to substance in idiopathic Parkinson's Disease patients requiring caregiver support. The possible answers were "applicable" and "not applicable".
Measured: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Application Form in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support
The physician was asked if he / she prescribed Neupro® due to application form in idiopathic Parkinson's Disease patients requiring caregiver support. The possible answers were "applicable" and "not applicable".
Measured: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia
This individual question from the caregivers' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians.
Measured: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Nausea and/or Vomiting in Patients With Nausea and/or Vomiting.
This individual question from the physicians' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians.
Measured: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance
This individual question from the physicians' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians.
Measured: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication
This individual question from the physicians' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians.
Measured: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Surgery Requiring General Anaesthesia
This individual question from the physicians' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians.
Measured: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dose Adaption
This individual question from the physicians' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians.
Measured: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration
This individual question from the physicians' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians.
Measured: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients
This individual question from the physicians' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians.
Measured: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Risk of Interaction With Other Treatments
This individual question from the physicians' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians.
Measured: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Resorption
This individual question from the physicians' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians.
Measured: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia
This individual question from the caregivers' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers.
Measured: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Nausea and/or Vomiting in Patients With Nausea and/or Vomiting
This individual question from the caregivers' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers.
Measured: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance
This individual question from the caregivers' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers.
Measured: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication
This individual question from the caregivers' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers.
Measured: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration
This individual question from the caregivers' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers.
Measured: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients
This individual question from the caregivers' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers.
Measured: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Care-giving Efforts
This individual question from the caregivers' questionnaire was to be assessed from "major disadvantages" to "major advantages", and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.
Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers.
Measured: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2012
- Study completionAug 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
- Cross-sectional
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330290
- Sponsor's protocol ID
- SP0939
- Acronym
- CARE-ACT
- Status last verified
- Nov 2013
- First submitted
- 18 Mar 2011
- Last updated
- 10 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sieb JP, Themann P, Warnecke T, Lauterbach T, Berkels R, Grieger F, Lorenzl S. Caregivers' and physicians' attitudes to rotigotine transdermal patch versus oral Parkinson's disease medication: an observational study. Curr Med Res Opin. 2015 May;31(5):967-74. doi: 10.1185/03007995.2015.1030376.
PubMed 25772231
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-site, Non-interventional, Cross-sectional Evaluation of the Caregivers' and the Physicians' Preferred Route of Administration and the Physicians' Rationale for the Choice of Neupro® in Patients With Parkinson Requiring Caregiver Support
- ClinicalTrials.gov ID
- NCT01330290
- Acronym / sponsor ID
- CARE-ACT / SP0939
- Conditions
- Idiopathic Parkinson's Disease
- Keywords
- Rotigotine, Neupro®, Parkinson, Treatment preference, Care-giving
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 6 Apr 2011 (estimated)
- Results
- Posted 10 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objective is to evaluate advantages and disadvantages of Neupro® versus oral anti-Parkinson medication by caregivers and physicians in idiopathic Parkinson's Disease patients requiring caregiver support in nursing home or outpatient care settings.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neupro® Treatment | – | Drug: Neupro®Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Idiopathic Parkinson's Disease (iPD) patients treated with a combination of L-dopa or other oral iPD drug and Neupro® for at least one month and requiring caregiver support documented as per medical records Every consecutive, eligible patient to be treated with Neupro® as per physician's decision
Key inclusion criteria (4 listed)
- Only patients having signed the consent form regarding study information, data transfer and data use
- The patients suffer from idiopathic Parkinson's Disease (iPD) treated with a combination of L-dopa or another oral iPD drug and Neupro® for at least one month
- The patients require caregiver support documented as per medical records (e.g. based on German level of care intensity 1 or greater)
- The decision to prescribe Neupro® must have been made by the physician independent of his/her decision to include the patient in the study
Key exclusion criteria (2 listed)
- Patients not fulfilling the inclusion criteria
- And according to Summary of Product Characteristics (SmPC): Hypersensitivity to the active substance or to any of the excipients, magnetic resonance tomography (MRT) or cardioversion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neupro®Also: RotigotineNeupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed. | Drug | Neupro® Treatment |
Primary outcome
Mean Score of the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
The caregivers were asked to fill out a questionnaire composed of 7 questions covering caregiving aspects. The mean score is calculated from the scores for the single responses which are rated from 'great disadvantages' to 'great advantages' and scored on a 5-point scale from -2 to +2. Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers.
Mean Score of the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
The physicians were asked to fill out a questionnaire composed of 10 questions covering medical and caregiving aspects. The mean score is calculated from the scores for the single responses which are rated from 'great disadvantages' to 'great advantages' and scored on a 5-point scale from -2 to +2. Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians.
19 secondary outcomes
Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Substance in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Application Form in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Nausea and/or Vomiting in Patients With Nausea and/or Vomiting.
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Surgery Requiring General Anaesthesia
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dose Adaption
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Risk of Interaction With Other Treatments
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Resorption
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Nausea and/or Vomiting in Patients With Nausea and/or Vomiting
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Care-giving Efforts
Time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25772231Sieb JP, Themann P, Warnecke T, Lauterbach T, Berkels R, Grieger F, Lorenzl S. Caregivers' and physicians' attitudes to rotigotine transdermal patch versus oral Parkinson's disease medication: an observational study. Curr Med Res Opin. 2015 May;31(5):967-74. doi: 10.1185/03007995.2015.1030376.
- Product informationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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)
54 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 at 54 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 4 inclusion and 2 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 10 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 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 10 Dec 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?
Mean Score of the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication (time frame: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.). The study lists 2 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 NCT01330290, 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 10 Dec 2013.