A Trial To Assess Switching From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System In Idiopathic Parkinson's Disease
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson's Disease
Intervention: Rotigotine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
John Whitesides, Study Director, Affiliation: Schwarz Biosciences Inc.
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.
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Primary outcome: Tolerability of rotigotine as determined by the total number of subjects completing the trial.Effect on symptoms and other variables. Safety.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Idiopathic Parkinson's disease
Exclusion Criteria:
- Not taking a dopamine agonist
Locations and Contacts
Schwarz, RTP, North Carolina, United States
Additional Information
Related publications: 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.
Starting date: December 2004
Ending date: July 2005
Last updated: April 16, 2008
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