Phase 3 N=136 Randomized Triple-blind Treatment

Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance

Restless Legs Syndrome · Restless Legs Syndrome (RLS)

Bottom Line

View on ClinicalTrials.gov: NCT00748098 ↗

Enrolled (actual)

136

Serious AEs

0.8%

Results posted

May 2011

Primary outcome: Primary: Adjusted Mean Change From Baseline in Wake Time During Sleep (WTDS) at Week 4/10 Measured by Polysomnography (PSG) (Sleep Study) Using Last Observation Carried Forward (LOCF) — -6.02; -32.02 minutes — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: GSK1838262 Extended Release Tablets (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: XenoPort, Inc.
Primary completion: Jul 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Adjusted Mean Change From Baseline in Wake Time During Sleep (WTDS) at Week 4/10 Measured by Polysomnography (PSG) (Sleep Study) Using Last Observation Carried Forward (LOCF)	-6.02; -32.02	<0.0001 sig
SECONDARY Adjusted Mean Change From Baseline in Periodic Limb Movements Associated With Arousal (PLMAI) at Week 4/10 as Measured by Polysomnography Using LOCF	-1.52; -4.59	0.002 sig
SECONDARY Adjusted Mean Change From Baseline in the International Restless Legs Rating Scale (IRLS) Total Score at Week 4/10 Using LOCF	-8.42; -14.99	—
SECONDARY Adjusted Mean Change From Baseline in the Item 4 (Sleep Disturbance) Scores of the IRLS Rating Scale at Week 4/10 Using LOCF	-1.47; -2.27	—
SECONDARY Adjusted Mean Change From Baseline in Time Spent in N1 Sleep as Measured by Polysomnography at Week 4/10 Using LOCF	-0.95; -6.19	—
SECONDARY Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N1 Sleep Stage at Week 4/10 Using LOCF	-0.23; -2.55	—
SECONDARY Adjusted Mean Change From Baseline in Time Spent in the N2 Sleep Stage as Measured by Polysomnography at Week 4/10 Using LOCF	2.78; 22.95	—
SECONDARY Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N2 Sleep Stage at Week 4/10	0.16; 0.64	—
SECONDARY Mean Change From Baseline in the Total Time Spent in Stage N3 Sleep Time at Week 4/10 Measured by PSG Using LOCF	2.89; 15.02	—
SECONDARY Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N3 Sleep Stage at Week 4/10	0.57; 2.62	—
SECONDARY Adjusted Mean Change From Baseline in Time Spent in the REM (Rapid Eye Movement) Sleep Stage at Week 4/10 as Measured by Polysomnography Using LOCF	-1.21; 4.22	—
SECONDARY Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the REM Sleep Stage at Week 4/10	-0.49; -0.71	—
SECONDARY Adjusted Mean Change From Baseline in Periodic Limb Movements Causing Awakening (PLMAWI) at Week 4/10 as Measured by Polysomnography Using LOCF	-0.08; -0.22	—
SECONDARY Number of PLMAI Responders at Week 4/10 Using LOCF	44; 64	—
SECONDARY Adjusted Mean Change From Baseline in Sleep Quality at Week 4/10 as Measured by the Subjective Post Sleep Diary (SPSD) Using LOCF	0.85; 1.95	—
SECONDARY Adjusted Mean Change From Baseline in Participant's Ratings of Feeling Rested Upon Awakening as Measured by the Subjective Post Sleep Diary (SPSD) at Week 4/10 Using LOCF.	0.83; 1.68	—
SECONDARY Adjusted Mean Change From Baseline in the Number of Awakenings Measured Objectively by Polysomnography at Week 4/10 Using LOCF	-0.56; -3.04	—
SECONDARY Adjusted Mean Change From Baseline in the Self-reported Number of Hours Spent Awake During the Night (SPSD) Due to RLS at Week 4/10 Using LOCF	-0.45; -0.56	—
SECONDARY Number of Participants With no Self-reported Awakenings (SPSD) Due to RLS at Week 4/10 Using LOCF	68; 87	—
SECONDARY Adjusted Mean Change From Baseline in the Total Sleep Time Measured by Polysomnography (PSG) at Week 4/10 Using LOCF	3.62; 36.32	—
SECONDARY Adjusted Mean Change From Baseline in the Sleep Efficiency Measured by Polysomnography (PSG) at Week 4/10 Using LOCF	0.76; 7.57	—
SECONDARY Adjusted Mean Change From Baseline in the Wake After Sleep Onset (WASO) Measured by Polysomnography (PSG) at Week 4/10 Using LOCF.	-3.76; -32.24	—
SECONDARY Adjusted Mean Change From Baseline in the Suggested Immobilization Test (SIT) PLM Index at Week 4/10	-3.73; -30.52	—
SECONDARY Adjusted Mean Change From Baseline in the SIT MDS (Mean Leg Discomfort Score), Mean of Scores From 0 to 60 Minutes, at Week 4/10	-8.57; -21.24	—
SECONDARY Number of Participants Who Responded Affirmatively to Each of the 4 Items of the Participant-completed Patient Global Impression of Therapy at Week 4/10 Using LOCF	53; 95; 39; 77; 31; 80	—
SECONDARY Adjusted Mean Change From Baseline in the Clinical Global Impression of Illness - Severity (CGI-S) Score at Week 4/10 Using LOCF	-1.18; -2.43	—
SECONDARY Number of Participants Who Were Defined as Clinical Global Impression of Illness (CGI-I) Scale "Responders" at Week 4/10 Using LOCF	46; 91	—
SECONDARY Number of Participants Who Self-reported "Very Satisfied" or "Satisfied" With the Investigational Product at Week 4/10 Using LOCF	22; 38; 23; 35	—

Summary

The purpose of this study is to assess the efficacy and safety of GSK1838262 extended release tablets in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance.

Eligibility Criteria

Inclusion criteria

Provided written informed consent.
Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 15 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS rating scale.
Have history of RLS symptoms at least 15 nights/month.
Minimum average of 15 Periodic Limb Movements during Sleep per hour (measured using actigraphy).

Exclusion criteria

Secondary RLS
Primary sleep disorder
Sleep apnea
Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.
Use of any prohibited medication.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00748098). 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.