A Trial To Assess Switching From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System In Idiopathic Parkinson's Disease

• Sponsor: UCB Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00242008
• Collaborator: (none)
• Location: 1
• Duration (Months): 7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: Rotigotine	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Dec 1, 2004
• Actual Primary Completion Date: Jul 1, 2005
• Actual Study Completion Date: Jul 1, 2005

Outcome Measures

Primary Outcome Measures

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

2. Effect on symptoms and other variables. []

3. Safety. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• Idiopathic Parkinson's disease

Exclusion Criteria:

• Not taking a dopamine agonist

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Schwarz	RTP	North Carolina	United States

Sponsors and Collaborators

• UCB Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center, UCB Pharma

Study Documents (Full-Text)

None provided.

More Information

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.

• ClinicalTrials.gov Identifier: NCT00242008
• Other Study ID Numbers: SP0824; 2004-002650-59
• First Posted: Oct 19, 2005
• Last Update Posted: Sep 25, 2014
• Last Verified: Sep 1, 2009

• Keywords provided by , ,: IDIOPATHIC PARKINSON'S DISEASE
• Additional relevant MeSH terms: Parkinson Disease; Rotigotine

Study Results

No Results Posted as of Sep 25, 2014