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An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT00501969
Recruitment Status : Completed
First Posted : July 17, 2007
Results First Posted : January 12, 2010
Last Update Posted : October 2, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Brief Summary:
The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with advanced-stage idiopathic Parkinson's disease

Condition or disease Intervention/treatment Phase
Advanced Stage Parkinson's Disease Drug: Rotigotine Phase 3

Detailed Description:
This is the open-label extension to the randomized, double-blind, placebo-and active controlled SP515 (NCT00244387) trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease that were not well-controlled on levodopa

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 395 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension to the Double-Blind SP515 (NCT00244387) Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease Who Are Not Well Controlled on L-Dopa
Study Start Date : August 2004
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Rotigotine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Rotigotine
Rotigotine
Drug: Rotigotine

Rotigotine trans-dermal patches once daily:

20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours) 50 cm2 (10 mg/24 hours) 60 cm2 (12 mg/24 hours) 70 cm2 (14 mg/24 hours) 80 cm2 (16 mg/24 hours)

Other Name: Neupro®



Primary Outcome Measures :
  1. Number of Subjects With at Least One Adverse Event During This Open-label Extension Study [ Time Frame: five years ]
    Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.


Secondary Outcome Measures :
  1. Number of Subjects Who Withdrew From the Trial Due to an Adverse Event [ Time Frame: five years ]
    Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

  2. Mean Epworth Sleepiness Scale Score During the Open-label Extension [ Time Frame: Visit 13 (end of year 1), Visit 17 (end of year 2), Visit 21 (end of year 3), Visit 25(end of year 4) ]
    The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.



Information from the National Library of Medicine

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Ages Eligible for Study:   31 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who have completed four months of maintenance treatment in the SP515 (NCT00244387) double-blind trial

Exclusion Criteria:

  • Subjects who had an ongoing serious adverse event from SP515 (NCT00244387) double-blind trial that was assessed as related to study medication

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): NCT00501969


  Show 53 Study Locations
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)

Additional Information:
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00501969     History of Changes
Other Study ID Numbers: SP0516
2004-000148-26 ( EudraCT Number )
First Posted: July 17, 2007    Key Record Dates
Results First Posted: January 12, 2010
Last Update Posted: October 2, 2014
Last Verified: March 2012

Keywords provided by UCB Pharma:
Rotigotine
Neupro®

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Rotigotine
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs