A Trial To Assess Switching From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System In Idiopathic Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rotigotine
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring IDIOPATHIC PARKINSON'S DISEASE
Eligibility Criteria
Inclusion Criteria: Idiopathic Parkinson's disease Exclusion Criteria: Not taking a dopamine agonist
Sites / Locations
- Schwarz
Outcomes
Primary Outcome Measures
Tolerability of rotigotine as determined by the total number of subjects completing the trial.
Effect on symptoms and other variables.
Safety.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00242008
Brief Title
A Trial To Assess Switching From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System In Idiopathic Parkinson's Disease
Official Title
A Phase 3b, Open-Label, Multicenter, Multinational Trial To Assess The Tolerability Of Switching Subjects From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System And Its Effect On Symptoms In Subjects With Idiopathic Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
5. Study Description
Brief Summary
The purpose of this trial is to assess whether it is possible for subjects with idiopathic Parkinson's Disease to switch from ropinirole, pramipexole and cabergoline to rotigotine transdermal system (SPM 962) overnight without worsening of Parkinson's Disease symptoms.
Subjects who meet eligibility criteria will be switched overnight to treatment with rotigotine transdermal patches at a dose considered equivalent to the dose of dopamine agonist that the subject is currently taking. Subjects on ropinirole or pramipexole will take their last dose at bedtime and then apply rotigotine patch(es) upon awakening the next morning. Subjects on cabergoline will apply rotigotine patches 24 hours after the final dose of cabergoline. Subjects will continue rotigotine treatment for 28 days, during which dose can be increased or decreased as needed. At the end of treatment, subjects can select to enroll in an open-label extension trial.
The first subject was enrolled on 28 December 2004. The last subject was enrolled in June 2005 and the last subject visit was conducted in July 2005. This study is now closed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
IDIOPATHIC PARKINSON'S DISEASE
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rotigotine
Primary Outcome Measure Information:
Title
Tolerability of rotigotine as determined by the total number of subjects completing the trial.
Title
Effect on symptoms and other variables.
Title
Safety.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Idiopathic Parkinson's disease
Exclusion Criteria:
Not taking a dopamine agonist
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Schwarz
City
RTP
State/Province
North Carolina
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17909303
Citation
LeWitt PA, Boroojerdi B, MacMahon D, Patton J, Jankovic J. Overnight switch from oral dopaminergic agonists to transdermal rotigotine patch in subjects with Parkinson disease. Clin Neuropharmacol. 2007 Sep-Oct;30(5):256-65. doi: 10.1097/wnf.0b013e318154c7c4.
Results Reference
background
Learn more about this trial
A Trial To Assess Switching From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System In Idiopathic Parkinson's Disease
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