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

Phase 3

Completed

• Conditions: Idiopathic Parkinson's Disease
• Interventions: Drug: Rotigotine

• Registration Number: NCT00505687
• Lead Sponsor: UCB Pharma

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2005-02
• Study First Submitted: 2007-07-20
• Study First Submitted QC: 2007-07-20
• Study First Posted: 2007-07-23
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2009-12-08
• Results First Submitted QC: 2009-12-08
• Results First Posted: 2010-01-12
• Status Verified: 2010-09
• Last Update Submitted: 2014-09-24
• Last Update Posted: 2014-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rotigotine	Rotigotine	Rotigotine

Primary Outcome Measures

Name	Time	Method
Number of Subjects With at Least One Adverse Event During This Open-label Extension Study	four years	Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Secondary Outcome Measures

Name	Time	Method
Mean Epworth Sleepiness Scale Score During the Open-label Extension.	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)	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.
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event	four years	Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.