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

NCT ID: NCT00501969

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

395 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

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 the rotigotine patch in subjects with advanced-stage idiopathic Parkinson's disease

Detailed Description

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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

Conditions

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Advanced Stage 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 trans-dermal patches once daily:

20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours) 50 cm2 (10 mg/24 hours) 60 cm2 (12 mg/24 hours) 70 cm2 (14 mg/24 hours) 80 cm2 (16 mg/24 hours)

Interventions

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Rotigotine

Rotigotine trans-dermal patches once daily:

20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours) 50 cm2 (10 mg/24 hours) 60 cm2 (12 mg/24 hours) 70 cm2 (14 mg/24 hours) 80 cm2 (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 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
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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Bedford Park, , Australia

Site Status

Concord, , Australia

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Darlinghurst, , Australia

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East Gosford, , Australia

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Westmead, , Australia

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Innsbruck, , Austria

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Zagreb, , Croatia

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Brno, , Czechia

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Ostrava - Poruba, , Czechia

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Pardubice, , Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Oulu, , Finland

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Pori, , Finland

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Aix-en-Provence, , France

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Lille, , France

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Lyon, , France

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Aachen, , Germany

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Bochum, , Germany

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Budapest, , Hungary

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Miskolc, , Hungary

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Pécs, , Hungary

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Petah Tikva, , Israel

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Tel Aviv, , Israel

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Milan, , Italy

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Napoli, , Italy

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Padua, , Italy

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Pisa, , Italy

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Pozzilli, , Italy

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Roma, , Italy

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Auckland, , New Zealand

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Christchurch, , New Zealand

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Wellington, , New Zealand

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Bergen, , Norway

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Stavanger, , Norway

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Trondheim, , Norway

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Tønsberg, , Norway

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Gdansk, , Poland

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Krakow, , Poland

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Lublin, , Poland

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Mosina k/Poznania, , Poland

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Olsztyn, , Poland

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Warsaw, , Poland

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Cape Town, , South Africa

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Pretoria, , South Africa

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Tygerberg, , South Africa

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Barcelona, , Spain

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Donostia / San Sebastian, , Spain

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Madrid, , Spain

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Stockholm, , Sweden

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Blackpool, , United Kingdom

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Glasgow, , United Kingdom

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Sheffield, , United Kingdom

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Countries

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Australia Austria Croatia Czechia Finland France Germany Hungary Israel Italy New Zealand Norway Poland South Africa Spain Sweden United Kingdom

Related Links

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Other Identifiers

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2004-000148-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SP0516

Identifier Type: -

Identifier Source: org_study_id

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