Transdermal Rotigotine User Surveillance Study (TRUST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00599339
First received: January 10, 2008
Last updated: July 24, 2015
Last verified: July 2015
  Purpose

This study will be conducted in an observational multiple-cohort design aimed at acquiring clinical, treatment, health status, and economic data. Patients with Parkinson's disease (PD) will be enrolled.


Condition
Idiopathic Parkinson Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Naturalistic, Multisite, Observational Study of Rotigotine Transdermal Patch and Other Currently Prescribed Therapies in Patients With Idiopathic Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) [ Time Frame: From Baseline to Visit 7 (Month 33) ] [ Designated as safety issue: No ]
    The Unified Parkinson's disease rating scale (UPDRS) Part III (Motor Examination) contains 31 questions. Each question ranges from 0 (best possible outcome) to 4 (worst outcome). The total score ranges from 0 (best possible outcome) to 124 (worst outcome).


Secondary Outcome Measures:
  • Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33) [ Time Frame: From Baseline to Visit 7 (Month 33) ] [ Designated as safety issue: No ]
    The Unified Parkinson's disease rating scale (UPDRS) question 32 of part IV asks. "What Proportion of the waking day are dyskinesias present?" Answers range from 0 (None) to 4 (76-100 % of the day).

  • Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33) [ Time Frame: From Baseline to Visit 7 (Month 33) ] [ Designated as safety issue: No ]
    The Unified Parkinson's disease rating scale (UPDRS) Part IV question 33 asks for complications of therapy in the past week, through the question "How disabling are the dyskinesias ? " Answers range from 0 (Not disabling) to 4 (Completely disabling).

  • Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33) [ Time Frame: 33 months ] [ Designated as safety issue: No ]
    The Unified Parkinson's disease rating scale (UPDRS) Part IV question 39 asks "What proportion of the waking day is the patient "off", on average?" Answers range from 0 (None) to 4 (76-100 % of the day).

  • Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33) [ Time Frame: 33 months ] [ Designated as safety issue: No ]

    The NADCS assesses sleep-related motor complaints including nocturnal akinesia, dystonia and painful cramps by an ordinal severity scale.

    The NADCS total score ranges from 0 (normal) to 4 (maximum severity). NADCS value was missing for one subject at Visit 7.


  • Hoehn & Yahr Stage at Visit 7 (Month 33) [ Time Frame: 33 months ] [ Designated as safety issue: No ]

    The Hoehn and Yahr staging of Parkinson's disease in the "on" stage, if applicable, had to be completed by the physician.

    Possible staging:

    • 0 No signs of disease
    • 1 Unilateral disease
    • 2 Bilateral disease without impairment of balance
    • 3 Mild to moderate bilateral disease, some postural instability, physically dependent
    • 4 Severe disability, still able to walk or stand unassisted
    • 5 Wheelchair bound or bedridden unless aided

  • Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months) [ Time Frame: 33 months ] [ Designated as safety issue: Yes ]
    The analysis was performed for the non-disjunctive classification into patients at risk to develop an Adverse Event associated with Rotigotine and patients at risk to develop an Adverse Event not associated with Rotigotine.


Enrollment: 2195
Study Start Date: June 2006
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Neupro
Neupro at study onset
Dopamine Agonist
Other Dopamine-Agonist at study onset
L-Dopa
L-Dopa
Neupro + L-Dopa
Neupro in combination with L-Dopa at study onset
Dopamine Agonist + L-Dopa
Other Dopamine Agonist in combination with L-Dopa at study onset

Detailed Description:

All patients attending the physician and fulfilling the eligibility criteria are included.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary Care

Criteria

Inclusion Criteria:

  • Patients with idiopathic early-stage Parkinson's Disease requiring dopaminergic monotherapy (rotigotine, other dopamine agonists or levodopa) at study onset
  • Patients with advanced-stage Parkinson's Disease requiring dopaminergic therapy with levodopa in combination with rotigotine or other dopamine agonists at study onset

Exclusion Criteria:

  • Patients who are unable to comply with study requirements
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599339

  Show 211 Study Locations
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00599339     History of Changes
Other Study ID Numbers: SP0854
Study First Received: January 10, 2008
Results First Received: April 10, 2015
Last Updated: July 24, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
Czech Republic: State Institute for Drug Control
Italy: The Italian Medicines Agency
Romania: National Medicines Agency
Slovakia: State Institute for Drug Control
Switzerland: Swissmedic
Greece: National Organization of Medicines
Denmark: Danish Medicines Agency
Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by UCB Pharma:
Rotigotine
Neupro

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Dopamine Agonists
N 0437
Dopamine Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 03, 2015