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An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease. (SP512OL)

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ClinicalTrials.gov Identifier: NCT00594165
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : February 25, 2010
Last Update Posted : October 2, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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 early-stage idiopathic Parkinson's disease.

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

Detailed Description:
This is the open-label extension to the randomized, double-blind, placebo-controlled SP512 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with early-stage idiopathic Parkinson's Disease.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension to the Double-Blind SP512 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's Disease.
Study Start Date : June 2002
Primary Completion Date : November 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: Rotigotine
Rotigotine
Drug: Rotigotine

Rotigotine trans-dermal patches:

10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours)

Optimal dosing:

During the first year:

The maximum Rotigotine dose allowed is 6 mg/24 hours.

After the first year: allowed dose increase of Rotigotine up to a maximum of 16 mg/24 hours.

Other Name: Neupro


Outcome Measures

Primary Outcome Measures :
  1. Number of Subjects With at Least One Adverse Event During This Open-label Extension Study [ Time Frame: 7 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: 7 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 9 (end of year 1), Visit 13 (end of year 2), Visit 17 (end of year 3), Visit 21(end of year 4), Visit 25 (end of year 5), Visit 29 (end of year 6), End of Treatment (last study visit or early withdrawal visit) ]
    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.


Eligibility Criteria

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 six months of maintenance treatment in the SP512 double-blind trial

Exclusion Criteria:

  • Subjects who had an ongoing serious adverse event from SP512 double-blind trial that was assessed as related to study medication
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): NCT00594165


  Show 42 Study Locations
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
More Information

Additional Information:
Publications:
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00594165     History of Changes
Other Study ID Numbers: SP0702
SP512OL
First Posted: January 15, 2008    Key Record Dates
Results First Posted: February 25, 2010
Last Update Posted: October 2, 2014
Last Verified: September 2010

Keywords provided by UCB Pharma:
Rotigotine

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