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

UCB Pharma186 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

186

Conditions

Idiopathic Parkinson's Disease

Interventions

RotigotineDRUG

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.

Eligibility

Sex: ALLMin age: 31 Years

Medical Language ↔ Plain English

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

Locations (26)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

St. Petersburg, Florida, United States

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: four 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: four 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 6 (post year 1), Visit 10 (post year 2), Visit 14 (post year 3), End of Treatment (last study visit or early withdrawal visit)

Data from ClinicalTrials.gov

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