We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00242008
Recruitment Status : Completed
First Posted : October 19, 2005
Last Update Posted : September 25, 2014
Sponsor:
Information provided by:

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  (Clinical Trial)
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 : December 2004
Primary Completion Date : July 2005
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Idiopathic Parkinson's disease

Exclusion Criteria:

  • Not taking a dopamine agonist
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00242008


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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00242008     History of Changes
Other Study ID Numbers: SP0824
2004-002650-59 ( EudraCT Number )
First Posted: October 19, 2005    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2009

Keywords provided by UCB Pharma:
IDIOPATHIC PARKINSON'S DISEASE

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