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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

UCB Pharma

ClinicalTrials.gov Identifier:

NCT00505687

First received: July 20, 2007

Last updated: September 24, 2014

Last verified: September 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

July 20, 2007

Last Updated Date

September 24, 2014

Start Date ^ICMJE

February 2005

Primary Completion Date

December 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of Subjects With at Least One Adverse Event During This Open-label Extension Study [ Time Frame: four years ]

Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Original Primary Outcome Measures ^ICMJE

Frequency and severity of AEs, changes in vital signs, body weight, ECG, and clinical laboratory values [ Time Frame: over the course of the trial ]

Change History

Complete list of historical versions of study NCT00505687 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of Subjects Who Withdrew From the Trial Due to an Adverse Event [ Time Frame: four years ]
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Mean Epworth Sleepiness Scale Score During the Open-label Extension. [ Time Frame: Visit 6 (post year 1), Visit 10 (post year 2), Visit 14 (post year 3), End of Treatment (last study visit or early withdrawal visit) ]
The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.

Original Secondary Outcome Measures ^ICMJE

Quality of sleep; quality of life; staging of severity of PD, motor performance [ Time Frame: changes from baseline ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Multicenter, Multinational, Phase 3b, Open-Label Extension Trial to Assess the Safety and Tolerability of Long-Term Treatment of Rotigotine Patch in Subjects With Idiopathic Parkinson's Disease

Brief Summary

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.

Detailed Description

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Idiopathic Parkinson's Disease

Intervention ^ICMJE

Drug: 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.

Other Name: Neupro

Study Arms

Experimental: Rotigotine

Rotigotine

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

Completed

Enrollment ^ICMJE

186

Completion Date

December 2008

Primary Completion Date

December 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

31 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

Austria, Germany, Israel, Italy, South Africa, Spain, United Kingdom, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00505687

Other Study ID Numbers ^ICMJE

SP0833
2004-002641-12 ( EudraCT Number )

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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