Polysomnography Study of GSK1838262 (XP13512) Extended Release Tablets Versus Placebo in Restless Legs Syndrome (RLS) and Associated Sleep Disturbance

Reporting Groups

	Description
All Participants in the Intent-to-Treat (ITT) Population	All randomized participants who took at least one dose of study drug and had at least one post-baseline polysomnography (PSG) efficacy assessment

Baseline Measures

	All Participants in the Intent-to-Treat (ITT) Population
Number of Participants   [units: participants]	131
Age [1] [units: Years] Mean ± Standard Deviation	52.0  ± 12.70
Gender [1] [units: Participants]
Female	76
Male	55
Race/Ethnicity, Customized [1] [units: participants]
African American/African Heritage	7
American Indian or Alaska Native	2
Asian	1
White	120
Mixed Race	1

1.  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)   [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

2.  Secondary:

Adjusted Mean Change From Baseline in Periodic Limb Movements Associated With Arousal (PLMAI) at Week 4/10 as Measured by Polysomnography Using LOCF   [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

3.  Secondary:

Adjusted Mean Change From Baseline in the International Restless Legs Rating Scale (IRLS) Total Score at Week 4/10 Using LOCF   [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

4.  Secondary:

Adjusted Mean Change From Baseline in the Item 4 (Sleep Disturbance) Scores of the IRLS Rating Scale at Week 4/10 Using LOCF   [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

5.  Secondary:

Adjusted Mean Change From Baseline in Time Spent in N1 Sleep as Measured by Polysomnography at Week 4/10 Using LOCF   [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

6.  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   [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

7.  Secondary:

Adjusted Mean Change From Baseline in Time Spent in the N2 Sleep Stage as Measured by Polysomnography at Week 4/10 Using LOCF   [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

8.  Secondary:

Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N2 Sleep Stage at Week 4/10   [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

9.  Secondary:

Mean Change From Baseline in the Total Time Spent in Stage N3 Sleep Time at Week 4/10 Measured by PSG Using LOCF   [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

10.  Secondary:

Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N3 Sleep Stage at Week 4/10   [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

11.  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   [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

12.  Secondary:

Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the REM Sleep Stage at Week 4/10   [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

13.  Secondary:

Adjusted Mean Change From Baseline in Periodic Limb Movements Causing Awakening (PLMAWI) at Week 4/10 as Measured by Polysomnography Using LOCF   [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

14.  Secondary:

Number of PLMAI Responders at Week 4/10 Using LOCF   [ Time Frame: Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

15.  Secondary:

Adjusted Mean Change From Baseline in Sleep Quality at Week 4/10 as Measured by the Subjective Post Sleep Diary (SPSD) Using LOCF   [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

16.  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.   [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

17.  Secondary:

Adjusted Mean Change From Baseline in the Number of Awakenings Measured Objectively by Polysomnography at Week 4/10 Using LOCF   [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

18.  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   [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

19.  Secondary:

Number of Participants With no Self-reported Awakenings (SPSD) Due to RLS at Week 4/10 Using LOCF   [ Time Frame: Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

20.  Secondary:

Adjusted Mean Change From Baseline in the Total Sleep Time Measured by Polysomnography (PSG) at Week 4/10 Using LOCF   [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

21.  Secondary:

Adjusted Mean Change From Baseline in the Sleep Efficiency Measured by Polysomnography (PSG) at Week 4/10 Using LOCF   [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

22.  Secondary:

Adjusted Mean Change From Baseline in the Wake After Sleep Onset (WASO) Measured by Polysomnography (PSG) at Week 4/10 Using LOCF.   [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

23.  Secondary:

Adjusted Mean Change From Baseline in the Suggested Immobilization Test (SIT) PLM Index at Week 4/10   [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

24.  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   [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

25.  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   [ Time Frame: Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

26.  Secondary:

Adjusted Mean Change From Baseline in the Clinical Global Impression of Illness – Severity (CGI-S) Score at Week 4/10 Using LOCF   [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

27.  Secondary:

Number of Participants Who Were Defined as Clinical Global Impression of Illness (CGI-I) Scale "Responders" at Week 4/10 Using LOCF   [ Time Frame: Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]

28.  Secondary:

Number of Participants Who Self-reported “Very Satisfied” or “Satisfied” With the Investigational Product at Week 4/10 Using LOCF   [ Time Frame: Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ]