Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)
This is a multi-center, open-label extension trial conducted at the same European sites that participated in trial SP 709 (NCT00243217). The trial is designed to collect long-term safety and tolerability, efficacy correlates, and quality of life data in subjects with idiopathic Restless Leg Syndrome (RLS). The duration of treatment is approximately 5 years. Subject will be up-titrated to their optimal dose (administration of 1 patch per day, 5 different doses and patch sizes).
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label Extension Trial to Determine Safety and Tolerability of Long-term Transdermal Application of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome|
- Number of Subjects With at Least One Adverse Event, as Reported Spontaneously by the Subject or Observed by the Investigator, During the 5-year Open-label Extension. [ Time Frame: Up to five years ] [ Designated as safety issue: No ]Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
- Number of Subjects Who Withdrew From the Trial Due to an Adverse Event During the 5-year Open Label Extension [ Time Frame: Up to five years ] [ Designated as safety issue: No ]Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
|Study Start Date:||July 2003|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Rotigotine trans-dermal patch
Rotigotine transdermal patches once daily:
2.5cm2 (0.5mg/24 hours) 5cm2 (1mg/24 hours) 10cm2 (2mg/24 hours) 15cm2 (3mg/24 hours) 20cm2 (4mg/24 hours)
Other Name: Neupro®
Please refer to this study by its ClinicalTrials.gov identifier: NCT00498186
|Marburg, Germany, 35039|
|Alcira, Valencia, Spain|
|Study Director:||UCB Clinical Trial Call Center||+1 877 822 9493 (UCB)|