Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00333359
Status:
COMPLETED
Last Update Posted:
2013-07-22
First Post:
2006-06-01
Brief Title:
XP13512 Gabapentin Enacarbil Extension Study in Patients With Restless Legs Syndrome
Sponsor:
XenoPort Inc
Organization:
XenoPort Inc
Study Overview
Official Title:
An Open-Label 52-Week Extension Study Assessing XP13512 Safety and Efficacy in Patients With Restless Legs Syndrome
Status:
COMPLETED
Status Verified Date:
2011-05
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 primary objective of this trial is to assess the long-term safety and efficacy of XP13512 Gabapentin Enacarbil taken once daily for the treatment of patients suffering from Restless Legs Syndrome RLS
Detailed Description:
Study XP055 is a multicenter open-label 52-week extension study of XP13512 Gabapentin Enacarbil GEn given once daily to eligible subjects with Restless Legs Syndrome RLS who had previously completed 1 of the following studies and met eligibility criteria XP052 110963 NCT00298623 XP053 111460 NCT00365352 XP081 111462 NCT01332305 and XP083 111463 NCT01332318
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