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

Phase 3

Completed

• Conditions: Early Stage Parkinson's Disease
• Interventions: Drug: Rotigotine

• Registration Number: NCT00599196
• 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 the rotigotine patch in subjects with early-stage idiopathic Parkinson's disease

Detailed Description

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 Timeline

• Study Start: 2002-08
• Study First Submitted: 2007-12-24
• Study First Submitted QC: 2008-01-10
• Study First Posted: 2008-01-23
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2009-12-11
• Results First Submitted QC: 2009-12-11
• Results First Posted: 2010-01-18
• Status Verified: 2010-09
• Last Update Submitted: 2014-09-24
• Last Update Posted: 2014-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 381

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

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