Status:
COMPLETED
XP13512 (Gabapentin Enacarbil) Extension Study in Patients With Restless Legs Syndrome.
Lead Sponsor:
XenoPort, Inc.
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 Syndrom...
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 c...
Eligibility Criteria
Inclusion
- Patients who have successfully completed one of the following studies: XP052 (110963 \[NCT00298623\]), XP053 (111460 \[NCT00365352\]), XP081 (111462 \[NCT01332305\]), and XP083 (111463 \[NCT01332318\]).
Exclusion
- Subjects who, in the opinion of the Investigator, would be non-compliant with the study visit schedule, procedures, or medication administration.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
581 Patients enrolled
Trial Details
Trial ID
NCT00333359
Start Date
June 1 2006
End Date
December 1 2008
Last Update
July 22 2013
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