Phase 3 N=581 Treatment

XP13512 (Gabapentin Enacarbil) Extension Study in Patients With Restless Legs Syndrome.

Restless Legs Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00333359 ↗

Enrolled (actual)

581

Serious AEs

3.7%

Results posted

Jun 2011

Primary outcome: Primary: Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at Week 52 Using Observed Case (OC) — -16.3; -17.0; -16.8 points on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: XP13512 (GEn) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: XenoPort, Inc.
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at Week 52 Using Observed Case (OC)	-16.3; -17.0; -16.8	—
PRIMARY Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC	84; 300; 384; 152; 294; 446	—
SECONDARY Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC	-9.4; -14.6; -12.8; -15.6; -13.5; -14.2	—
SECONDARY Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC	38; 192; 230; 46; 108; 154	—
SECONDARY Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC	86; 304; 390; 145; 261; 406	—
SECONDARY Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC	39; 194; 233; 47; 110; 157	—
SECONDARY 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	106; 224; 330; 106; 216; 322	—
SECONDARY Median Time to Onset of the First RLS Symptom Using the RLS Symptom Record at Weeks 24 and 52	15.5; 20; 18; NA; NA; NA	—
SECONDARY Overall Quality of Life (QoL) Impact Score of the RLS Quality of Life Questionnaire at Weeks 24 and 52	89.8; 91.1; 90.7; 92.0; 92.0; 92.0	—
SECONDARY Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores	-0.2; 0.1; 0.0; -7.6; -2.3; -4.2	—
SECONDARY 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	-0.1; -0.1; -0.1; -1.8; -0.2; -0.8	—
SECONDARY Mean Change From Baseline at Weeks 24 and 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Item: RLS Affected Productivity	-0.8; -0.2; -0.4; -0.9; -0.1; -0.3	—

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).

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00333359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.