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Caregivers' and Physicians' Treatment Preference in Parkinson Patients Treated With Neupro® Requiring Caregiver Support (CARE-ACT)

This study has been completed.
Sponsor:
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
History of Changes
  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:

Drug Information available for: Rotigotine
U.S. FDA Resources

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

  Show 54 Study Locations
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 19, 2013