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A Trial To Assess Switching From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System In Idiopathic Parkinson's Disease
This study has been completed.
First Received: October 18, 2005   Last Updated: September 9, 2009   History of Changes
Sponsor: UCB, Inc.
Information provided by: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00242008
  Purpose

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 Intervention Phase
Parkinson's Disease
Drug: Rotigotine
Phase III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
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

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Tolerability of rotigotine as determined by the total number of subjects completing the trial.
  • Effect on symptoms and other variables.
  • Safety.

Study Start Date: December 2004
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Idiopathic Parkinson's disease

Exclusion Criteria:

  • Not taking a dopamine agonist
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242008

Locations
United States, North Carolina
Schwarz
RTP, North Carolina, United States
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center UCB, Inc.
  More Information

Additional Information:
Publications:
Study ID Numbers: SP824
Study First Received: October 18, 2005
Last Updated: September 9, 2009
ClinicalTrials.gov Identifier: NCT00242008     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
IDIOPATHIC PARKINSON'S DISEASE

Additional relevant MeSH terms:
Ropinirole
Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Antineoplastic Agents
Basal Ganglia Diseases
Physiological Effects of Drugs
Antiparkinson Agents
Neurodegenerative Diseases
Brain Diseases
Dopamine Agonists
Pramipexol
Movement Disorders
Therapeutic Uses
Nervous System Diseases
Central Nervous System Diseases
Protective Agents
Pharmacologic Actions
Parkinson Disease
Dopamine Agents
Parkinsonian Disorders
Cabergoline
Central Nervous System Agents
N 0437

ClinicalTrials.gov processed this record on November 09, 2009