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 Pharma

ClinicalTrials.gov Identifier:

NCT00519532

First received: August 21, 2007

Last updated: October 17, 2014

Last verified: September 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

August 21, 2007

Last Updated Date

October 17, 2014

Start Date ^ICMJE

July 2007

Primary Completion Date

May 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.
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.

Original Primary Outcome Measures ^ICMJE

Change in motor function, sleep quality and non-motor symptoms over the course of the trial [ Time Frame: baseline to end of maintenance ]

Change History

Complete list of historical versions of study NCT00519532 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.
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.

Original Secondary Outcome Measures ^ICMJE

Change in Pain; Depression; Safety variables [ Time Frame: baseline to end of maintenance ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Parkinson's Disease

Intervention ^ICMJE

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®

Study Arms

Experimental: Rotigotine

Rotigotine Transdermal Patch

Intervention: Drug: Rotigotine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

May 2009

Primary Completion Date

May 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Completion of trial SP889

Exclusion Criteria:

Ongoing serious adverse event assessed as related to trial medication

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Australia, Finland, Germany, Hungary, Italy, New Zealand, Poland, South Africa, Spain, United Kingdom, United States

Removed Location Countries

Austria

Administrative Information

NCT Number ^ICMJE

NCT00519532

Other Study ID Numbers ^ICMJE

SP0915
EudraCT number: 2006-006907-35 ( Other Identifier: EudraCT )

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

UCB Pharma

Study Sponsor ^ICMJE

UCB Pharma

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

PRS Account

UCB Pharma

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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