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...
Date First Received: October 18, 2005
Last Updated: April 16, 2008
Verified by: UCB, April 2008
Clinical Trial Phase: Phase 3 | Start Date: December 2004
Overall Status: Completed
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Study Primary Completion Date: July 2005
Intervention(s) in this Clinical Trial
- Drug: Rotigotine
Outcome Measures for this Clinical Trial
Primary Measures
- Tolerability of rotigotine as determined by the total number of subjects completing the trial.
- Effect on symptoms and other variables.
- Safety.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Idiopathic Parkinson's disease
Exclusion Criteria:
- Not taking a dopamine agonist
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Sponsor Information
Lead Sponsor: UCB
Overall Clinical Trial Officials and Contacts
John Whitesides Study Director Schwarz Biosciences Inc.
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on December 03, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00242008
Study ID Number: SP824
ClinicalTrials.gov Identifier: NCT00242008
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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