Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-01-03 @ 4:57 AM
Study NCT ID:
NCT00333359
Status:
COMPLETED
Last Update Posted:
2013-07-22
First Post:
2006-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
XP13512 (Gabapentin Enacarbil) Extension Study in Patients With Restless Legs Syndrome.
Sponsor:
XenoPort, Inc.
Organization:
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:
False
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?: