Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00498186
Status:
COMPLETED
Last Update Posted:
2014-10-02
First Post:
2007-07-06
Brief Title:
Long-term Open-label Trial in Idiopathic Restless Legs Syndrome RLS
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None