Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243217
Status:
COMPLETED
Last Update Posted:
2014-09-25
First Post:
2005-10-20
Brief Title:
Rotigotine Restless Legs Syndrome Dose Finding Trial
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
Official Title:
Multi-center Double-blind Randomized Placebo-controlled Six-arm Parallel-group Dose-finding Trial to Determine Efficacy Safety and Tolerability of Five Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Leg 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:
The objective of this trial is to demonstrate clinical efficacy of four different dosages of SPM 962 1125 mg 225 mg 45 mg and 675 mg corresponding to 25 cm2 5 cm2 10 cm2 and 15 cm2 patch size respectively in RLS subjects It is anticipated that rotigotine SPM 936 will be more effective than placebo The tolerability and safety of rotigotine will be assessed
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