Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00367822
Status:
COMPLETED
Last Update Posted:
2012-03-07
First Post:
2006-08-22
Brief Title:
Transdermal Lisuride a Trial for the Treatment of Patients With Restless Legs Syndrome RLS
Sponsor:
Axxonis Pharma AG
Organization:
Axxonis Pharma AG
Study Overview
Official Title:
Transdermal Lisuride a Double-blind Randomized Active- and Placebo-controlled Multi-centre Phase III Efficacy Trial for the Treatment of Patients With Restless Legs Syndrome RLS
Status:
COMPLETED
Status Verified Date:
2010-01
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 compare an individually optimized dose of the lisuride TTS patch against placebo and against an individually optimized dose of oral ropinirole active- and placebo-controlled design in idiopathic and uremic RLS patients with regard to efficacy safety and quality of life
Detailed Description:
Approximately 300 patients will be randomized to receive either lisuride ropinirole or placebo in a 211 fashion After completion of 12 weeks of double-blind treatment eligible patients will have the option to continue treatment with the lisuride patch for further 36 weeks in an open-label extension of the study
Primary outcome Changes in the total score of the International Restless Legs Severity Scale IRLS from baseline to end of double-blind treatment 12 weeks will be used as primary efficacy outcome measure
Secondary objectives are to evaluate quality of life safety and tolerability After the double-blind period long-term efficacy of lisuride will be assessed for further 36 weeks in an open-label extension of the study
Primary outcome Changes in the total score of the International Restless Legs Severity Scale IRLS from baseline to end of double-blind treatment 12 weeks will be used as primary efficacy outcome measure
Secondary objectives are to evaluate quality of life safety and tolerability After the double-blind period long-term efficacy of lisuride will be assessed for further 36 weeks in an open-label extension of the study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT No 2005-003549-16 | None | None | None |