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An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE3

An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease

An Open-Label Extension to the Double-Blind SP515 (NCT00244387) Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease Who Are Not Well Controlled on L-Dopa

NCT00501969•UCB Pharma

View on ClinicalTrials.gov

Summary

The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with advanced-stage idiopathic Parkinson's disease

Detailed Description

This is the open-label extension to the randomized, double-blind, placebo-and active controlled SP515 (NCT00244387) trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease that were not well-controlled on levodopa

Eligibility

Age

31 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects who have completed four months of maintenance treatment in the SP515 (NCT00244387) double-blind trial

Exclusion Criteria

•Subjects who had an ongoing serious adverse event from SP515 (NCT00244387) double-blind trial that was assessed as related to study medication

Locations (53)

Bedford Park, Australia

Concord, Australia

Darlinghurst, Australia

East Gosford, Australia

Westmead, Australia

Innsbruck, Austria

Zagreb, Croatia

Brno, Czechia

Ostrava - Poruba, Czechia

Pardubice, Czechia

Key Dates

Start Date

August 1, 2004

Primary Completion Date

December 1, 2008

Completion Date

December 1, 2008

Last Updated

October 2, 2014

Enrollment

395

ACTUAL participants

Conditions

Advanced Stage Parkinson's Disease

Interventions

Rotigotine

DRUG

A Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesia.

NCT00903838

Advanced Stage Parkinson's Disease

View study

COMPLETEDPHASE3

An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.

NCT00407095

Advanced Stage Parkinson's Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 2, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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