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An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's Disease

NCT ID: NCT00505687

Last Updated: 2014-10-02

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2008-12-31

Brief Summary

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The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of rotigotine in subjects with idiopathic PD.

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Detailed Description

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This is the open-label extension to the open-label trials SP824 (NCT00242008), SP825 (NCT00243971), and SP826 (NCT00243945) that assessed the efficacy and safety and tolerability of rotigotine in subjects with idiopathic Parkinson's Disease.

Conditions

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Idiopathic 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

Group Type EXPERIMENTAL

Rotigotine

Intervention Type DRUG

Rotigotine transdermal patches:

10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours)

Optimal dosing:

The maximum rotigotine dose allowed is 16 mg/24 hours.

Interventions

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Rotigotine

Rotigotine transdermal patches:

10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours)

Optimal dosing:

The maximum rotigotine dose allowed is 16 mg/24 hours.

Intervention Type DRUG

Other Intervention Names

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Neupro

Eligibility Criteria

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Inclusion Criteria

* Subjects who have completed treatment in one of the SP824 (NCT00242008), SP825 (NCT00243971), or SP826 (NCT00243945) trials

Exclusion Criteria

* Subjects who had an ongoing serious adverse event from the previous OLE trial that was assessed as related to study medication
Minimum Eligible Age

31 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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Birmingham, Alabama, United States

Site Status

St. Petersburg, Florida, United States

Site Status

Fort Wayne, Indiana, United States

Site Status

Southfield, Michigan, United States

Site Status

Forest Hills, New York, United States

Site Status

Asheville, North Carolina, United States

Site Status

Raleigh, North Carolina, United States

Site Status

Houston, Texas, United States

Site Status

Milwaukee, Wisconsin, United States

Site Status

Innsbruck, , Austria

Site Status

Bochum, , Germany

Site Status

Dresden, , Germany

Site Status

Kassel, , Germany

Site Status

Ulm, , Germany

Site Status

Tel Aviv, , Israel

Site Status

Ancona, , Italy

Site Status

Lucca, , Italy

Site Status

Messina, , Italy

Site Status

Pretoria, Gauteng, South Africa

Site Status

Parow, Western Cape, South Africa

Site Status

Plumstead, Western Cape, South Africa

Site Status

Barcelona, , Spain

Site Status

Barncose Terrace, Redruth, United Kingdom

Site Status

Bridgend, , United Kingdom

Site Status

North Shields, , United Kingdom

Site Status

Tyne and Wear, , United Kingdom

Site Status

Countries

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United States Austria Germany Israel Italy 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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2004-002641-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SP0833

Identifier Type: -

Identifier Source: org_study_id

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