Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's Disease

This study has been terminated.
(Due to clinical trial supplies shortage)
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00519532
First received: August 21, 2007
Last updated: August 30, 2011
Last verified: September 2010
  Purpose

The objective of this open-label extension is to assess the long-term effect of the 24-hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non-motor symptoms of Parkinson's disease. The long-term safety and tolerability of the rotigotine transdermal patch will also be evaluated.


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: A Multicenter, Multinational, Phase 3b, Open-label Extension Trial to Evaluate the Long-term Effect of the 24-hour Transdermal Delivery of Rotigotine on Motor Function, Sleep Quality, and Nocturnal and Non-motor Symptoms in Subjects With Idiopathic Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance) [ Time Frame: Baseline (baseline SP915) and week 13 (End of maintenance) ] [ Designated as safety issue: No ]

    The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the elements in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities.

    Baseline is defined as first titration visit (T1) of SP915.


  • Change From Baseline in Parkinson Disease Sleep Scale (PDSS) at Week 13 (End of Maintenance) [ Time Frame: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance) ] [ Designated as safety issue: No ]

    The Parkinson Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores range between 0= never and 4= very often.

    Baseline is defined as Visit 2 of previous double- blind trial SP889.



Secondary Outcome Measures:
  • Change From Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) at Week 13 (End of Maintenance) [ Time Frame: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance) ] [ Designated as safety issue: No ]

    Subjects were asked to assess nocturnal akinesia, dystonia and cramps, using an ordinal severity scale. While a score of 0= normal and 4= maximal severity, subjects could also rate their symptoms with values of 0.5, 1.5, 2.5, 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps scores were used to evaluate sleep.

    Baseline is defined as Visit 2 of previous double- blind trial SP889.


  • Change From Baseline in Number of Nocturias at Week 13 (End of Maintenance) [ Time Frame: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance) ] [ Designated as safety issue: No ]

    The change in number of nocturias was used to evaluate improvements in sleep disorders.

    Baseline is defined as Visit 2 of previous double- blind trial SP889.



Enrollment: 84
Study Start Date: July 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rotigotine
Rotigotine Transdermal Patch
Drug: Rotigotine

Rotigotine transdermal patches:

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

Optimal dosing: The maximum rotigotine dose allowed is 16mg/24h

Other Name: Neupro®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completion of trial SP889

Exclusion Criteria:

  • Ongoing serious adverse event assessed as related to trial 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: NCT00519532

Locations
United States, Florida
St. Petersburg, Florida, United States, 33701
United States, North Carolina
Salisbury, North Carolina, United States, 28144
Australia
Concord, Australia
Finland
Oulu, Finland, 90220
Germany
Berlin, Germany, 10713
Dresden, Germany, 01307
Kassel, Germany, 34128
Marburg, Germany, 35039
Naumburg, Germany, 06618
Ulm, Germany, 89081
Hungary
Budapest, Hungary, 1145
Nyiregyhaza, Hungary, 4400
Italy
Chieti, Italy
Milano, Italy, 20127
New Zealand
Christchurch, New Zealand
Poland
Olyszytn, Poland
South Africa
Cape Town, South Africa
Spain
Barcelona, Spain
Madrid, Spain
United Kingdom
Lancashire, United Kingdom
Liverpool, United Kingdom, L9 7JL
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: NCT00519532     History of Changes
Other Study ID Numbers: SP915, EudraCT number: 2006-006907-35
Study First Received: August 21, 2007
Results First Received: March 17, 2010
Last Updated: August 30, 2011
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Spain: Spanish Agency of Medicines
Hungary: National Institute of Pharmacy
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Austria: Agency for Health and Food Safety
Finland: Finnish Medicines Agency
New Zealand: Medsafe
South Africa: Medicines Control Council
Australia: Department of Health and Ageing Therapeutic Goods Administration
Poland: Ministry of Health

Keywords provided by UCB, Inc.:
Neupro®
Rotigotine
Parkinson's Disease

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 19, 2014