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

NCT ID: NCT00519532

Last Updated: 2014-10-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rotigotine

Rotigotine Transdermal Patch

Group Type EXPERIMENTAL

Rotigotine

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Neupro®

Eligibility Criteria

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Inclusion Criteria

* Completion of trial SP889

Exclusion Criteria

* Ongoing serious adverse event assessed as related to trial medication
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

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St. Petersburg, Florida, United States

Site Status

Salisbury, North Carolina, United States

Site Status

Concord, , Australia

Site Status

Oulu, , Finland

Site Status

Berlin, , Germany

Site Status

Dresden, , Germany

Site Status

Kassel, , Germany

Site Status

Marburg, , Germany

Site Status

Naumburg, , Germany

Site Status

Ulm, , Germany

Site Status

Budapest, , Hungary

Site Status

Nyíregyháza, , Hungary

Site Status

Chieti, , Italy

Site Status

Milan, , Italy

Site Status

Christchurch, , New Zealand

Site Status

Olyszytn, , Poland

Site Status

Cape Town, , South Africa

Site Status

Barcelona, , Spain

Site Status

Madrid, , Spain

Site Status

Lancashire, , United Kingdom

Site Status

Liverpool, , United Kingdom

Site Status

Countries

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

Related Links

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http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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EudraCT number: 2006-006907-35

Identifier Type: OTHER

Identifier Source: secondary_id

SP0915

Identifier Type: -

Identifier Source: org_study_id

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