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

UCB Pharma381 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 early-stage idiopathic Parkinson's disease

This is the open-label extension to the randomized, double-blind, placebo- and ropinirole-controlled SP513 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with early-stage idiopathic Parkinson's Disease

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

381

Conditions

Early Stage Parkinson's Disease

Interventions

RotigotineDRUG

Rotigotine trans-dermal patches, once daily: 10 cm2 (2 mg/24 hours); 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); Optimal dosing: During the first year: The maximum Rotigotine dose allowed is 8 mg/24 hours. After the first year: allowed dose increase of rotigotine up to a maximum of 16 mg/24 hours.

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who have completed six months of maintenance treatment in the SP513 double-blind trial Exclusion Criteria: * Subjects who had an ongoing serious adverse event from SP513 double-blind trial that was assessed as related to study medication

Locations (63)

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: six 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: six 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 10 (end of year 1), Visit 14 (end of year 2), Visit 18 (end of year 3), Visit 22 (end of year 4), Visit 26 (end of year 5), Visit 30 (end of year 6), End of Treatment (last study visit or early withdrawal visit)

Data from ClinicalTrials.gov

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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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Vienna, Austria

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Brussels, Belgium

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Hoboken, Belgium

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Zagreb, Croatia

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Brno, Czechia

...and 53 more locations