Caregivers' and Physicians' Treatment Preference in Parkinson Patients Treated With Neupro® Requiring Caregiver Support (CARE-ACT)
This study has been completed.
Sponsor:
UCB, Inc.
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01330290
First received: March 18, 2011
Last updated: September 25, 2012
Last verified: September 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Idiopathic Parkinson's Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| 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 |
Resource links provided by NLM:
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- Mean score of the caregivers' rating of Neupro® compared to oral anti-Parkinson medication [ Time Frame: After at least one month of treatment with Rotigotine in combination with an oral IPD treatment, measurement (documentation) at a single time point ] [ Designated as safety issue: No ]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.
- Mean score of the physicians' rating of Neupro® compared to oral anti-Parkinson medication [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Assessment of the physicians' rationale for the choice of Neupro® due to substance in idiopathic Parkinsons Disease patients requiring caregiver support [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]
- Assessment of the physicians' rationale for the choice of Neupro® due to application form in idiopathic Parkinsons Disease patients requiring caregiver support [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]
- 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: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]The response is rated on a 5-point scale from -2 to 2.
- Score for the physicians' rating of Neupro® compared to oral anti-Parkinson medication in relation to control of compliance [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]The response is rated on a 5-point scale from -2 to 2.
- 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: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]The response is rated on a 5-point scale from -2 to 2.
- Score for the physicians' rating of Neupro® compared to oral anti-Parkinson medication in relation to surgery requiring general anaesthesia. [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]The response is rated on a 5-point scale from -2 to 2.
- Score for the physicians' rating of Neupro® compared to oral anti-Parkinson medication in relation to dose adaption. [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]The response is rated on a 5-point scale from -2 to 2.
- Score for the physicians' rating of Neupro® compared to oral anti-Parkinson medication with regard to independency of food administration. [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]The response is rated on a 5-point scale from -2 to 2.
- Score for the physicians' rating of Neupro® compared to oral anti-Parkinson medication with regard to sleeping patients. [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]The response is rated on a 5-point scale from -2 to 2.
- Score for the physicians' rating of Neupro® compared to oral anti-Parkinson medication in relation to risk of interaction with other treatments. [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]The response is rated on a 5-point scale from -2 to 2.
- Score for the physicians' rating of Neupro® compared to oral anti-Parkinson medication in relation to resorption. [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]The response is rated on a 5-point scale from -2 to 2.
- Score for the caregivers' rating of Neupro® compared to oral anti-Parkinson medication in relation to dysphagia in patients with dysphagia. [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]The response is rated on a 5-point scale from -2 to 2.
- 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: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]The response is rated on a 5-point scale from -2 to 2.
- Score for the caregivers' rating of Neupro® compared to oral anti-Parkinson medication in relation to control of compliance [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]The response is rated on a 5-point scale from -2 to 2.
- 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: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]The response is rated on a 5-point scale from -2 to 2.
- Score for the caregivers' rating of Neupro® compared to oral anti-Parkinson medication with regard to independency of food administration. [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]The response is rated on a 5-point scale from -2 to 2.
- Score for the caregivers' rating of Neupro® compared to oral anti-Parkinson medication with regard to sleeping patients. [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]The response is rated on a 5-point scale from -2 to 2.
- Score for the caregivers' rating of Neupro® compared to oral anti-Parkinson medication in relation to care-giving efforts [ Time Frame: Single measurement after at least one month of treatment with Rotigotine in combination with an oral IPD treatment preceding onset of study ] [ Designated as safety issue: No ]The response is rated on a 5-point scale from -2 to 2.
| Enrollment: | 148 |
| Study Start Date: | March 2011 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Neupro® Treatment
Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24h) as per approved label in EU/in accordance with the terms of the local marketing authorization for Neupro®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Criteria
Inclusion Criteria:
- Only patients having signed the consent form regarding study information, data transfer and data use
- The patients suffer from 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.
Exclusion Criteria:
- Patients not fulfilling the inclusion criteria
- And according to SmPC: Hypersensitivity to the active substance or to any of the excipients, magnetic resonance tomography (MRT) or cardioversion
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330290
Hide Study Locations
Hide Study LocationsLocations
| Germany | |
| 52 | |
| Abensberg, Germany | |
| 53 | |
| Alzenau, Germany | |
| 18 | |
| Beelitz-Heilstätten, Germany | |
| 42 | |
| Bensheim, Germany | |
| 27 | |
| Berlin, Germany | |
| 24 | |
| Berlin, Germany | |
| 37 | |
| Celle, Germany | |
| 17 | |
| Dillingen, Germany | |
| 48 | |
| Dresden, Germany | |
| 32 | |
| Eisenach, Germany | |
| 39 | |
| Erbach, Germany | |
| 43 | |
| Erfurt, Germany | |
| 60 | |
| Essen, Germany | |
| 38 | |
| Geldern, Germany | |
| 5 | |
| Gelnhausen, Germany | |
| 40 | |
| Gelsenkirchen, Germany | |
| 31 | |
| Göttingen, Germany | |
| 29 | |
| Hagen, Germany | |
| 6 | |
| Halle, Germany | |
| 57 | |
| Halle, Germany | |
| 28 | |
| Hamm, Germany | |
| 47 | |
| Hannover, Germany | |
| 7 | |
| Herborn, Germany | |
| 55 | |
| Hoppegarten, Germany | |
| 59 | |
| Jena, Germany | |
| 50 | |
| Karlstadt, Germany | |
| 44 | |
| Konigsbruck, Germany | |
| 58 | |
| Köln, Germany | |
| 51 | |
| Lappersdorf, Germany | |
| 8 | |
| Lohr, Germany | |
| 4 | |
| Marktheidenfeld, Germany | |
| 45 | |
| Merzig, Germany | |
| 36 | |
| Minden, Germany | |
| 34 | |
| Mittweida, Germany | |
| 25 | |
| Muenchen, Germany | |
| 35 | |
| Mühldorf am Inn, Germany | |
| 41 | |
| München, Germany | |
| 30 | |
| Münster, Germany | |
| 49 | |
| Neuburg, Germany | |
| 21 | |
| Neumarkt, Germany | |
| 13 | |
| Niederschoena, Germany | |
| 9 | |
| Oschatz, Germany | |
| 54 | |
| Schorndorf, Germany | |
| 2 | |
| Schriesheim, Germany | |
| 1 | |
| Stralsund, Germany | |
| 12 | |
| Stratroda, Germany | |
| 15 | |
| Stuttgard, Germany | |
| 33 | |
| Stuttgart, Germany | |
| 20 | |
| Ulm, Germany | |
| 14 | |
| Unterhaching, Germany | |
| 22 | |
| Weil Am Rhein, Germany | |
| 11 | |
| Westerstede, Germany | |
| 23 | |
| Wolfach, Germany | |
| 56 | |
| Wolfratshausen, Germany | |
Sponsors and Collaborators
UCB, Inc.
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
More Information
No publications provided
| Responsible Party: | UCB, Inc. |
| ClinicalTrials.gov Identifier: | NCT01330290 History of Changes |
| Other Study ID Numbers: | SP0939 |
| Study First Received: | March 18, 2011 |
| Last Updated: | September 25, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by UCB, Inc.:
|
Rotigotine Neupro® Parkinson Treatment preference Care-giving |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
N 0437 Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013