An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's Disease

September 24, 2014 updated by: UCB Pharma

A Multicenter, Multinational, Phase 3b, Open-Label Extension Trial to Assess the Safety and Tolerability of Long-Term Treatment of Rotigotine Patch in Subjects With Idiopathic Parkinson's Disease

The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of rotigotine in subjects with idiopathic PD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is the open-label extension to the open-label trials SP824 (NCT00242008), SP825 (NCT00243971), and SP826 (NCT00243945) that assessed the efficacy and safety and tolerability of rotigotine in subjects with idiopathic Parkinson's Disease.

Study Type

Interventional

Enrollment (Actual)

186

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
  • Germany
      • Bochum, Germany
      • Dresden, Germany
      • Kassel, Germany
      • Ulm, Germany
  • Israel
      • Tel Aviv, Israel
  • Italy
      • Ancona, Italy
      • Lucca, Italy
      • Messina, Italy
  • South Africa
    • Gauteng
      • Pretoria, Gauteng, South Africa
    • Western Cape
      • Parow, Western Cape, South Africa
      • Plumstead, Western Cape, South Africa
  • Spain
      • Barcelona, Spain
  • United Kingdom
      • Bridgend, United Kingdom
      • North Shields, United Kingdom
      • Tyne and Wear, United Kingdom
    • Redruth
      • Barncose Terrace, Redruth, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Florida
      • St. Petersburg, Florida, United States
    • Indiana
      • Fort Wayne, Indiana, United States
    • Michigan
      • Southfield, Michigan, United States
    • New York
      • Forest Hills, New York, United States
    • North Carolina
      • Asheville, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Texas
      • Houston, Texas, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

31 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who have completed treatment in one of the SP824 (NCT00242008), SP825 (NCT00243971), or SP826 (NCT00243945) trials

Exclusion Criteria:

  • Subjects who had an ongoing serious adverse event from the previous OLE trial that was assessed as related to study medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:

The maximum rotigotine dose allowed is 16 mg/24 hours.

Other Names:
  • Neupro

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event
Time Frame: four years
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
four years
Mean Epworth Sleepiness Scale Score During the Open-label Extension.
Time Frame: Visit 6 (post year 1), Visit 10 (post year 2), Visit 14 (post year 3), 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.
Visit 6 (post year 1), Visit 10 (post year 2), Visit 14 (post year 3), End of Treatment (last study visit or early withdrawal visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

July 20, 2007

First Submitted That Met QC Criteria

July 20, 2007

First Posted (ESTIMATE)

July 23, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

October 2, 2014

Last Update Submitted That Met QC Criteria

September 24, 2014

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0833
  • 2004-002641-12 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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