Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135993
Status:
COMPLETED
Last Update Posted:
2014-09-25
First Post:
2005-08-24
Brief Title:
Four Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Legs Syndrome
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
Official Title:
A Multi-Center Randomized Double-Blind Placebo-Controlled Five-Arm Parallel-Group Trial to Investigate the Efficacy and Safety of Four Different Transdermal Doses of 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:
Subjects who meet the diagnosis of idiopathic restless legs syndrome RLS based on the 4 cardinal clinical features according to the International Restless Legs Syndrome Study Group IRLSSG are allowed to enroll in this trial
The primary objective of this trial is to demonstrate that rotigotine SPM 936 is efficacious in subjects with idiopathic restless legs syndrome Additional objectives are to investigate the safety and tolerability of rotigotine
Subjects will be randomized to receive either placebo 1125 225 45 or 675mgday rotigotine in a 11111 activeplacebo fashion Approximately 600 subjects will be enrolled in this trial participating at approximately 60 sites The maximum duration of the trial is approximately 8 months consisting of a 4-week Titration Period a 6-month Maintenance Period a 7-day Taper Period and a 30-day Safety Follow-Up Period
The primary objective of this trial is to demonstrate that rotigotine SPM 936 is efficacious in subjects with idiopathic restless legs syndrome Additional objectives are to investigate the safety and tolerability of rotigotine
Subjects will be randomized to receive either placebo 1125 225 45 or 675mgday rotigotine in a 11111 activeplacebo fashion Approximately 600 subjects will be enrolled in this trial participating at approximately 60 sites The maximum duration of the trial is approximately 8 months consisting of a 4-week Titration Period a 6-month Maintenance Period a 7-day Taper Period and a 30-day Safety Follow-Up Period
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