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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00599196
First received: December 24, 2007
Last updated: August 30, 2011
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 early-stage idiopathic Parkinson's disease


Condition Intervention Phase
Early Stage Parkinson's Disease
Drug: Rotigotine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Extension to the Double-Blind SP513 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Number of Subjects With at Least One Adverse Event During This Open-label Extension Study [ Time Frame: six 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: six 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 10 (end of year 1), Visit 14 (end of year 2), Visit 18 (end of year 3), Visit 22 (end of year 4), Visit 26 (end of year 5), Visit 30 (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: 381
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
Rotigotine
Drug: Rotigotine

Rotigotine trans-dermal patches, once daily:

10 cm2 (2 mg/24 hours); 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);

Optimal dosing:

During the first year: The maximum Rotigotine dose allowed is 8 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- and ropinirole-controlled SP513 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with early-stage idiopathic Parkinson's Disease

  Eligibility

Ages Eligible for Study:   30 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 SP513 double-blind trial

Exclusion Criteria:

  • Subjects who had an ongoing serious adverse event from SP513 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: NCT00599196

  Hide Study Locations
Locations
Australia
Concord, Australia
Darlinghurst, Australia
East Gosford, Australia
Westmead, Australia
Austria
Innsbruck, Austria
Wien, Austria
Belgium
Brussels, Belgium
Hoboken, Belgium
Croatia
Zagreb, Croatia
Czech Republic
Brno, Czech Republic
Ostrava, Czech Republic
Plzen, Czech Republic
Finland
Espoo, Finland
Kuopio, Finland
Lappeenranta, Finland
Oulu, Finland
Pori, Finland
France
Aix-en -Provence, France
Caen Cedex, France
Toulouse Cedex, France
Germany
Aachen, Germany
Dresden, Germany
Kiel, Germany
Marburg, Germany
Hungary
Budapest, Hungary
Miskolc, Hungary
Pecs, Hungary
Israel
Hadera, Israel
Petach-Tikva, Israel
Tel Aviv, Israel
Italy
Milano, Italy
Padova, Italy
Pozzilli, Italy
Netherlands
Breda, Netherlands
Geldrop, Netherlands
New Zealand
Auckland, New Zealand
Christchurch, New Zealand
North Shore, New Zealand
Wellington, New Zealand
Norway
Stavanger, Norway
Trondheim, Norway
Poland
Gdansk, Poland
Katowice, Poland
Krakόw, Poland
Lublin, Poland
Mosina k/Poznania, Poland
Olsztyn, Poland
Warszawa, Poland
South Africa
Cape Town, South Africa
Pretoria, South Africa
Spain
Barcelona, Spain
Pamplona, Spain
Sweden
Karlstad, Sweden
Stockholm, Sweden
Switzerland
Bern, Switzerland
Lausanne, Switzerland
United Kingdom
Birmingham, United Kingdom
Blackpool, United Kingdom
Glasgow, United Kingdom
Liverpool, United Kingdom
London, United Kingdom
Newcastle Upon Tyne, United Kingdom
Swansea, United Kingdom
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided by UCB Pharma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00599196     History of Changes
Other Study ID Numbers: SP716, SP513OL
Study First Received: December 24, 2007
Results First Received: December 11, 2009
Last Updated: August 30, 2011
Health Authority: Austria: Agency for Health and Food Safety
Australia: Department of Health and Ageing Therapeutic Goods Administration
Croatia: Ministry of Science, Education and Sports
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Finland: Finnish Medicines Agency
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
New Zealand: Health Research Council
Norway: Norwegian Medicines Agency
Poland: Ministry of Health
South Africa: Department of Health
Sweden: Medical Products Agency
Switzerland: Swissmedic
Italy: Ministry of Health
Spain: Comité Ético de Investigación Clínica
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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
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 September 14, 2014