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

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

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.

Study Overview

• Status: Terminated
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: Rotigotine

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 3

Contacts and Locations

Study Locations

• 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
• United States
  • Florida
    • St. Petersburg, Florida, United States, 33701
  • North Carolina
    • Salisbury, North Carolina, United States, 28144

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Completion of trial SP889

Exclusion Criteria:

• Ongoing serious adverse event assessed as related to trial medication

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Neupro®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in UPDRS III Score at 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.	Baseline (baseline SP915) and week 13 (End of maintenance)
Change From Baseline in Parkinson Disease Sleep Scale (PDSS) at 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.	Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) at 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.	Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)
Change From Baseline in Number of Nocturias at 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.	Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)

Collaborators and Investigators

• Sponsor: UCB Pharma

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: August 21, 2007
• First Submitted That Met QC Criteria: August 21, 2007
• First Posted (Estimate): August 22, 2007

Study Record Updates

• Last Update Posted (Estimate): October 27, 2014
• Last Update Submitted That Met QC Criteria: October 17, 2014
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Parkinson's Disease; Rotigotine; Neupro®
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine Agonists; Dopamine Agents; Rotigotine
• Other Study ID Numbers: SP0915; EudraCT number: 2006-006907-35 (Other Identifier: EudraCT)