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

• ClinicalTrials.gov Identifier: NCT00519532
• Recruitment Status: Terminated
• First Posted: August 22, 2007
• Results First Posted: April 2, 2010
• Last Update Posted: October 27, 2014
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Parkinson's Disease	Drug: Rotigotine	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 84 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: July 2007
• Actual Primary Completion Date: May 2009
• Actual Study Completion Date: May 2009

Arms and Interventions

Arm	Intervention/treatment
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®

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance) [ Time Frame: Baseline (baseline SP915) and week 13 (End of maintenance) ]

   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.

2. 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) ]

   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 :

1. 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) ]

   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.

2. 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) ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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 Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493 (UCB)

More Information

Additional Information:

FDA Safety Alerts and Recalls 

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00519532
• Other Study ID Numbers: SP0915; EudraCT number: 2006-006907-35 ( Other Identifier: EudraCT )
• First Posted: August 22, 2007
• Results First Posted: April 2, 2010
• Last Update Posted: October 27, 2014
• Last Verified: September 2010

Keywords provided by UCB Pharma:

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; Synucleinopathies; Neurodegenerative Diseases; Rotigotine; Dopamine Agonists; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs