Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263068
Status:
COMPLETED
Last Update Posted:
2014-09-25
First Post:
2005-12-05
Brief Title:
An Extension Trial to Investigate Long-Term Treatment With Transdermal Rotigotine in Idiopathic Restless Legs Syndrome
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
Official Title:
An Open-Label Extension Trial to Investigate the Safety and Tolerability of Long-Term Treatment With Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
Status:
COMPLETED
Status Verified Date:
2009-09
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 multicenter open-label trial to assess safety and tolerability of rotigotine SPM 936 in subjects with idiopathic Restless Legs Syndrome RLS administered at an optimal dose for up to 1 year Subjects who successfully completed the Maintenance Period and the Taper Period of SP792 are allowed to enroll in this trial
All subjects will begin the Titration Period at a daily dosage of 1125mg rotigotine 25cm2 patch Subjects will be up-titrated at 7-day intervals in 1125mg 25cm2 increments initial titration step only and 225mg intervals 5cm2 increments to a maximum dose of 675mgday 15cm2 rotigotine The maximum length of titration is 28 days 3 days although not all subjects will require 28 days to reach their optimal dose
A subjects dose may be increased or decreased as needed by the investigator to maintain a subjects effective dose during the Maintenance Period A Taper Period is provided to allow for safe gradual withdrawal from trial medication
All subjects will begin the Titration Period at a daily dosage of 1125mg rotigotine 25cm2 patch Subjects will be up-titrated at 7-day intervals in 1125mg 25cm2 increments initial titration step only and 225mg intervals 5cm2 increments to a maximum dose of 675mgday 15cm2 rotigotine The maximum length of titration is 28 days 3 days although not all subjects will require 28 days to reach their optimal dose
A subjects dose may be increased or decreased as needed by the investigator to maintain a subjects effective dose during the Maintenance Period A Taper Period is provided to allow for safe gradual withdrawal from trial medication
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