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

Phase 3CompletedNCT00501969

UCB Pharma395 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

395

Conditions

Advanced Stage Parkinson's Disease

Interventions

RotigotineDRUG

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)

Eligibility

Sex: ALLMin age: 31 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Number of Subjects With at Least One Adverse Event During This Open-label Extension Study

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

Time frame: five years

Secondary Outcomes

Number of Subjects Who Withdrew From the Trial Due to an Adverse Event

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

Time frame: five years

Mean Epworth Sleepiness Scale Score During the Open-label Extension

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.

Time frame: Visit 13 (end of year 1), Visit 17 (end of year 2), Visit 21 (end of year 3), Visit 25(end of year 4)

Data from ClinicalTrials.gov

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Bedford Park, Australia

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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

...and 43 more locations