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

September 24, 2014 updated by: UCB Pharma

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

395

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

  • Australia
      • Bedford Park, Australia
      • Concord, Australia
      • Darlinghurst, Australia
      • East Gosford, Australia
      • Westmead, Australia
  • Austria
      • Innsbruck, Austria
  • Croatia
      • Zagreb, Croatia
  • Czech Republic
      • Brno, Czech Republic
      • Ostrava - Poruba, Czech Republic
      • Pardubice, Czech Republic
      • Plzen, Czech Republic
      • Praha, Czech Republic
  • Finland
      • Oulu, Finland
      • Pori, Finland
  • France
      • Aix-en -Provence, France
      • Lille cedex, France
      • Lyon, France
  • Germany
      • Aachen, Germany
      • Bochum, Germany
  • Hungary
      • Budapest, Hungary
      • Miskolc, Hungary
      • Pecs, Hungary
  • Israel
      • Petach-Tikva, Israel
      • Tel Aviv, Israel
  • Italy
      • Milano, Italy
      • Napoli, Italy
      • Padova, Italy
      • Pisa, Italy
      • Pozzilli, Italy
      • Roma, Italy
  • New Zealand
      • Auckland, New Zealand
      • Christchurch, New Zealand
      • Wellington, New Zealand
  • Norway
      • Bergen, Norway
      • Stavanger, Norway
      • Tonsberg, Norway
      • Trondheim, Norway
  • Poland
      • Gdansk, Poland
      • Krakow, Poland
      • Lublin, Poland
      • Mosina k/Poznania, Poland
      • Olsztyn, Poland
      • Warszawa, Poland
  • South Africa
      • Cape Town, South Africa
      • Pretoria, South Africa
      • Tygerberg, South Africa
  • Spain
      • Barcelona, Spain
      • Madrid, Spain
      • San Sebastian, Spain
  • Sweden
      • Stockholm, Sweden
  • United Kingdom
      • Blackpool, United Kingdom
      • Glasgow, United Kingdom
      • Sheffield, United Kingdom

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 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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 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: five years
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
five 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: five years
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
five years
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.
Visit 13 (end of year 1), Visit 17 (end of year 2), Visit 21 (end of year 3), Visit 25(end of year 4)

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

August 1, 2004

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

July 16, 2007

First Submitted That Met QC Criteria

July 16, 2007

First Posted (Estimate)

July 17, 2007

Study Record Updates

Last Update Posted (Estimate)

October 2, 2014

Last Update Submitted That Met QC Criteria

September 24, 2014

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0516
  • 2004-000148-26 (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.

Clinical Trials on Advanced Stage Parkinson's Disease

Clinical Trials on Rotigotine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe