Clinical trial NCT00333359: XP13512 (Gabapentin Enacarbil) Extension Study in Patients With Restless Legs Syndrome.
Official title: An Open-Label, 52-Week Extension Study Assessing XP13512 Safety and Efficacy in Patients With Restless Legs Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Restless Legs Syndrome
Lead sponsor: XenoPort, Inc.
Sponsor class: INDUSTRY
First posted: 2006-06-05
Enrollment: 581
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 \[NCT01332318\]).

Eligibility criteria: Inclusion Criteria:

* Patients who have successfully completed one of the following studies: XP052 (110963 \[NCT00298623\]), XP053 (111460 \[NCT00365352\]), XP081 (111462 \[NCT01332305\]), and XP083 (111463 \[NCT01332318\]).

Exclusion Criteria:

* Subjects who, in the opinion of the Investigator, would be non-compliant with the study visit schedule, procedures, or medication administration.

Primary outcomes:
measure: Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at Week 52 Using Observed Case (OC)
timeFrame: Baseline and Week 52
measure: Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC
timeFrame: Weeks 0, 1, 4, 12, 24, 36, and 52
Secondary outcomes:
measure: Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC
timeFrame: Weeks 0, 1, 4, 12, 24, and 36
measure: Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC
timeFrame: Weeks 0, 1, and 52
measure: Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC
timeFrame: Weeks 0, 1, 4, 12, 24, 36, and 52
measure: Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC
timeFrame: Weeks 0, 1, and 52
measure: Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data
timeFrame: Week 52
measure: Median Time to Onset of the First RLS Symptom Using the RLS Symptom Record at Weeks 24 and 52
timeFrame: Weeks 24 and 52
measure: Overall Quality of Life (QoL) Impact Score of the RLS Quality of Life Questionnaire at Weeks 24 and 52
timeFrame: Weeks 24 and 52
measure: Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores
timeFrame: Baseline and Weeks 24 and 52
measure: Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked
timeFrame: Baseline and Weeks 24 and 52
measure: Mean Change From Baseline at Weeks 24 and 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Item: RLS Affected Productivity
timeFrame: Baseline and Weeks 24 and 52
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Ellenbogen AL, Thein SG, Winslow DH, Becker PM, Tolson JM, Lassauzet ML, Chen D. A 52-week study of gabapentin enacarbil in restless legs syndrome. Clin Neuropharmacol. 2011 Jan-Feb;34(1):8-16. doi: 10.1097/WNF.0b013e3182087d48.