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

Phase 3

Terminated

• Conditions: Parkinson's Disease
• Interventions: Drug: Rotigotine

• Registration Number: NCT00519532
• Lead Sponsor: UCB Pharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-08-21
• Study First Submitted QC: 2007-08-21
• Study First Posted: 2007-08-22
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Results First Submitted: 2010-03-17
• Results First Submitted QC: 2010-03-17
• Results First Posted: 2010-04-02
• Status Verified: 2010-09
• Last Update Submitted: 2014-10-17
• Last Update Posted: 2014-10-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Completion of trial SP889

Exclusion Criteria

• Ongoing serious adverse event assessed as related to trial medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rotigotine	Rotigotine	Rotigotine Transdermal Patch

Primary Outcome Measures

Name	Time	Method
Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance)	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.
Change From Baseline in Parkinson Disease Sleep Scale (PDSS) at Week 13 (End of Maintenance)	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

Name	Time	Method
Change From Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) at Week 13 (End of Maintenance)	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.
Change From Baseline in Number of Nocturias at Week 13 (End of Maintenance)	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.