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Clinical Trials/NCT00242008
NCT00242008
Completed
Phase 3

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

UCB Pharma1 site in 1 countryDecember 2004

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
UCB Pharma
Locations
1
Primary Endpoint
Effect on symptoms and other variables.
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2004
End Date
July 2005
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
UCB Pharma

Eligibility Criteria

Inclusion Criteria

  • Idiopathic Parkinson's disease

Exclusion Criteria

  • Not taking a dopamine agonist

Outcomes

Primary Outcomes

Effect on symptoms and other variables.

Tolerability of rotigotine as determined by the total number of subjects completing the trial.

Safety.

Study Sites (1)

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