An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advance-Stage Parkinson's Disease (SP715)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00594386
First received: December 24, 2007
Last updated: May 25, 2012
Last verified: September 2010
  Purpose

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 Intervention Phase
Parkinson's Disease
Drug: Rotigotine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Extension to the Double-Blind SP650 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease.

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Number of Subjects With at Least One Adverse Event During This Open-label Extension Study [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    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:
  • Number of Subjects Who Withdrew From the Trial Due to an Adverse Event. [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

  • Mean Epworth Sleepiness Scale Score During the Open-label Extension. [ Time Frame: Visit 11 (end of year 1), Visit 15 (end of year 2), Visit 19 (end of year 3), Visit 23 (end of year 4), Visit 27 (end of year 5), Visit 31 (end of year 6), End of Treatment (last study visit or early withdrawal visit) ] [ Designated as safety issue: No ]
    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.


Enrollment: 258
Study Start Date: August 2002
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rotigotine Drug: Rotigotine

Rotigotine transdermal 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

Detailed Description:

This is the open-label extension to the randomized, double-blind, placebo-controlled SP650 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease who are not well-controlled on Levodopa.

  Eligibility

Ages Eligible for Study:   31 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who have completed six months of maintenance treatment in the SP650 double-blind trial

Exclusion Criteria:

  • Subjects who had an ongoing serious adverse event from the SP650 double-blind trial that was assessed as related to study medication
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594386

  Show 41 Study Locations
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00594386     History of Changes
Other Study ID Numbers: SP715
Study First Received: December 24, 2007
Results First Received: November 16, 2009
Last Updated: May 25, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by UCB, Inc.:
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
N 0437
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014