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

Primary Purpose

Restless Legs Syndrome, Restless Legs Syndrome (RLS)

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

GSK1838262 Extended Release Tablets

Placebo

About this trial

This is an interventional treatment trial for Restless Legs Syndrome focused on measuring PSG, Restless Legs Syndrome, gabapentin enacarbil, XP13512, GSK1838262, sleep disturbance, RLS, polysomnography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

GSK1838262:placebo

Placebo:GSK1838262

Arm Description

GSK1838262 extended release tablets for Treatment Period 1 followed by Placebo for Treatment Period 2

Placebo for Treatment Period 1 followed by GSK1838262 for Treatment Period 2

Outcomes

Primary Outcome Measures

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)

PSG is a comprehensive recording of the bio-physiological changes that occur during sleep. It is also known as a "sleep study" that monitors participants as they sleep or try to sleep. WTDS, defined as the total amount of time spent awake after falling asleep until the last awakening, was measured by PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

Secondary Outcome Measures

Adjusted Mean Change From Baseline in Periodic Limb Movements Associated With Arousal (PLMAI) at Week 4/10 as Measured by Polysomnography Using LOCF

PLMAI is defined as the number of Periodic Limb Movements (PLMs or involuntary jerks of the legs that cause a participant to arouse from sleep per hour of sleep). Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

Adjusted Mean Change From Baseline in the International Restless Legs Rating Scale (IRLS) Total Score at Week 4/10 Using LOCF

The IRLS is a measure of RLS disease severity. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

Adjusted Mean Change From Baseline in the Item 4 (Sleep Disturbance) Scores of the IRLS Rating Scale at Week 4/10 Using LOCF

The IRLS is a measure of RLS disease severity. Item 4 of the IRLS evaluates RLS-related sleep impairment. It asks: "In the past week, how severe was your sleep disturbance due to your RLS symptoms?". The item is participant rated using a 5-point scale, where 0 is the absence of any sleep disturbance and 4 is very severe disturbance. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

Adjusted Mean Change From Baseline in Time Spent in N1 Sleep as Measured by Polysomnography at Week 4/10 Using LOCF

Stage N1 is considered "light sleep," during which participants drift in and out of sleep and can be awakened easily. In this stage, the eyes move slowly and muscle activity slows. This stage is sometimes referred to as "somnolence" or "drowsy sleep." Sudden twitches and hypnic jerks may be associated with the onset of sleep during N1. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N1 Sleep Stage at Week 4/10 Using LOCF

Percentage of stage N1 sleep time was defined as the time spent in stage N1 sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

Adjusted Mean Change From Baseline in Time Spent in the N2 Sleep Stage as Measured by Polysomnography at Week 4/10 Using LOCF

In stage N2 of sleep, eye movement stops and brain waves become slower, with only an occasional burst of rapid brain waves. Participants may also experience spontaneous periods of muscle tone mixed with periods of muscle relaxation. During this stage, muscular activity, and conscious awareness of the external environment disappears. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N2 Sleep Stage at Week 4/10

Percentage of stage N2 sleep time was defined as the time spent in stage N2 sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

Mean Change From Baseline in the Total Time Spent in Stage N3 Sleep Time at Week 4/10 Measured by PSG Using LOCF

Stage N3 is referred to as deep sleep; it is very difficult to wake a participant in this stage of sleep. In deep sleep, there is no eye movement or muscle activity. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N3 Sleep Stage at Week 4/10

Percentage of stage N3 sleep time was defined as the time spent in stage N3 sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

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

In REM sleep, a participant's breathing becomes more rapid, irregular, and shallow; eyes jerk rapidly; and limb muscles are temporarily paralyzed. Brain waves during this stage increase to levels experienced when a person is awake. This is the stage when most dreams occur. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the REM Sleep Stage at Week 4/10

Percentage of stage REM sleep time was defined as the time spent in stage REM sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

Adjusted Mean Change From Baseline in Periodic Limb Movements Causing Awakening (PLMAWI) at Week 4/10 as Measured by Polysomnography Using LOCF

PLMAWI is defined as the number of PLMs (involuntary leg movements) that caused participants to wake up per hour of sleep. It is calculated by dividing the number of PLMs causing awakening by the total number of hours of sleep. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

Number of PLMAI Responders at Week 4/10 Using LOCF

PLMAI is defined as the number of PLMs associated with arousal per hour of sleep. Participants with <=5 PLMAI were evaluated as responders.

Adjusted Mean Change From Baseline in Sleep Quality at Week 4/10 as Measured by the Subjective Post Sleep Diary (SPSD) Using LOCF

Each day upon awakening, participants rated their overall sleep quality for the previous night on an 11-point scale (0=poor to 10=excellent) using the SPSD. Response to sleep quality was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

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.

Each day upon awakening, participants rated how rested they felt upon awakening on an 11-point scale (0=poor to 10=excellent) using the SPSD. Response to feeling rested upon awakening was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

Adjusted Mean Change From Baseline in the Number of Awakenings Measured Objectively by Polysomnography at Week 4/10 Using LOCF

The number of awakenings was measured by PSG and is defined as the number of wake periods lasting at least 1 minute. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

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

Each day upon awakening, participants recorded, using the SPSD, the total number of hours spent awake the previous night due to RLS. Response to number of hours awake was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

Number of Participants With no Self-reported Awakenings (SPSD) Due to RLS at Week 4/10 Using LOCF

Each day upon awakening, participants recorded, using the SPSD, the number of awakenings due to RLS they experienced the previous night. Number of awakenings was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis.

Adjusted Mean Change From Baseline in the Total Sleep Time Measured by Polysomnography (PSG) at Week 4/10 Using LOCF

Total sleep time is the number of minutes participants slept on average during the 8-hour polysomnography. Scoring of PSG data to yield measure of total sleep time was conducted at a central site in the United States. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effect.

Adjusted Mean Change From Baseline in the Sleep Efficiency Measured by Polysomnography (PSG) at Week 4/10 Using LOCF

Sleep efficiency is a percentage that is calculated by dividing total sleep time by the amount of time the participant was in bed during the PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effect.

Adjusted Mean Change From Baseline in the Wake After Sleep Onset (WASO) Measured by Polysomnography (PSG) at Week 4/10 Using LOCF.

Wake After Sleep Onset (WASO) is defined as the total amount of time spent awake after falling asleep until the end of PSG recording. This endpoint is measured objectively by PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects

Adjusted Mean Change From Baseline in the Suggested Immobilization Test (SIT) PLM Index at Week 4/10

During the SIT, participants sat in bed with legs extended for 1 hour and were asked to rate their leg discomfort on a 100 millimeters visual analog scale every 5 minutes (score of 0-100, 0=none, higher numbers indicate more discomfort) and PLMs were assessed. The SIT-PLM Index is defined as the number of PLMs per hour during the SIT. Mean change from baseline was adjusted for treatment, pooled center, and period effects. Only results from SITs performed before a PSG assessment and of at least 60 minutes in length are included in the analysis.

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

During the SIT, participants sat in bed with legs extended for 1 hour and rated their leg discomfort on a visual analog scale every 5 minutes (range 0-100, 0=none, higher numbers indicate more discomfort). The SIT MDS is the average rating of leg discomfort during the specified time frame. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects. Only results from SITs performed before a PSG assessment and of at least 60 minutes in length are included in the analysis.

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

Each participant completed the participant-completed Patient Global Impression questionnaire at the end of each Treatment Period (Weeks 4 and 10) or Early Withdrawal. This instrument was developed to capture a participant's subjective assessment of therapy and is composed of the following 4 questions with dichotomous (Yes or No) responses: "Helped me sleep," "Helped me fall asleep faster," "Helped me sleep longer," and "Helped me get a better night's sleep."

Adjusted Mean Change From Baseline in the Clinical Global Impression of Illness - Severity (CGI-S) Score at Week 4/10 Using LOCF

The CGI-S scale allows the investigator to rate the severity of participants' illness considering their total clinical experience with the participant population being studied and based on all information available at the time of rating. The scale is rated from 1-7 (1=Normal, not at all ill; 7=Among the most extremely ill patients). Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.

Number of Participants Who Were Defined as Clinical Global Impression of Illness (CGI-I) Scale "Responders" at Week 4/10 Using LOCF

The CGI-I scale allows the investigator to rate the participant's global improvement or worsening compared with the condition at baseline (i.e., Day 1), and whether or not the change is thought to be due to treatment with study medication. The scale is rated from 1-7 (1=Very much improved to 7=Very much worse). Participants with a score of 1 ("Very much improved") or 2 ("Much improved") are considered to be responders.

Number of Participants Who Self-reported "Very Satisfied" or "Satisfied" With the Investigational Product at Week 4/10 Using LOCF

Participant satisfaction with RLS medication was captured on a seven-point ordinal scale. The scale asked "Overall, how satisfied are you with the medication you received for the treatment of your RLS symptoms during the study." The participant responses ranged from 1 ("Very satisfied") to 7 ("Very dissatisfied"). A "satisfied" response was scored a 2.

Full Information

NCT ID

NCT00748098

First Posted

September 5, 2008

Last Updated

July 15, 2013

Sponsor

XenoPort, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00748098

Brief Title

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

Official Title

Study RXP110908, a Polysomnography Study of GSK1838262 (XP13512) Extended Release Tablets Versus Placebo in the Treatment of Restless Legs Syndrome (RLS) and Associated Sleep Disturbance

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

XenoPort, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

Double-blind, multi-center, placebo-controlled, 2-period crossover study which assessed the efficacy and safety of gabapentin enacarbil (GEn; GSK1838262; XP13512) extended release tablets in adults with Restless Legs Syndrome (RLS)-associated sleep disturbance. One hundred thirty-six (136) adult subjects with RLS-associated sleep disturbance and periodic limb movements (PLM) were randomized from 23 centers in the United States. Subjects who met all eligibility criteria were randomized to receive a treatment sequence of GEn:placebo or placebo:GEn. Investigational product was taken with food at approximately 5pm. Investigational product was dosed as 600mg/day x3 days followed by 1200mg/day x25 days for each 4-week treatment period. There was a 1-week taper at 600mg after each treatment period followed by a 1-week washout between treatments. Polysomnography (PSG) was used to objectively evaluate changes in sleep and PLMs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Restless Legs Syndrome, Restless Legs Syndrome (RLS)

Keywords

PSG, Restless Legs Syndrome, gabapentin enacarbil, XP13512, GSK1838262, sleep disturbance, RLS, polysomnography

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

136 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GSK1838262:placebo

Arm Type

Other

Arm Description

GSK1838262 extended release tablets for Treatment Period 1 followed by Placebo for Treatment Period 2

Arm Title

Placebo:GSK1838262

Arm Type

Other

Arm Description

Placebo for Treatment Period 1 followed by GSK1838262 for Treatment Period 2

Intervention Type

Drug

Intervention Name(s)

GSK1838262 Extended Release Tablets

Other Intervention Name(s)

XP13512, gabapentin enacarbil

Intervention Description

GSK1838262 extended release tablets

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

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)

Description

Time Frame

Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Secondary Outcome Measure Information:

Title

Adjusted Mean Change From Baseline in Periodic Limb Movements Associated With Arousal (PLMAI) at Week 4/10 as Measured by Polysomnography Using LOCF

Description

Time Frame

Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

Adjusted Mean Change From Baseline in the International Restless Legs Rating Scale (IRLS) Total Score at Week 4/10 Using LOCF

Description

Time Frame

Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

Adjusted Mean Change From Baseline in the Item 4 (Sleep Disturbance) Scores of the IRLS Rating Scale at Week 4/10 Using LOCF

Description

Time Frame

Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

Adjusted Mean Change From Baseline in Time Spent in N1 Sleep as Measured by Polysomnography at Week 4/10 Using LOCF

Description

Time Frame

Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N1 Sleep Stage at Week 4/10 Using LOCF

Description

Time Frame

Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

Adjusted Mean Change From Baseline in Time Spent in the N2 Sleep Stage as Measured by Polysomnography at Week 4/10 Using LOCF

Description

Time Frame

Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N2 Sleep Stage at Week 4/10

Description

Time Frame

Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

Mean Change From Baseline in the Total Time Spent in Stage N3 Sleep Time at Week 4/10 Measured by PSG Using LOCF

Description

Time Frame

Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N3 Sleep Stage at Week 4/10

Description

Time Frame

Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

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

Description

Time Frame

Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the REM Sleep Stage at Week 4/10

Description

Time Frame

Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

Adjusted Mean Change From Baseline in Periodic Limb Movements Causing Awakening (PLMAWI) at Week 4/10 as Measured by Polysomnography Using LOCF

Description

Time Frame

Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

Number of PLMAI Responders at Week 4/10 Using LOCF

Description

PLMAI is defined as the number of PLMs associated with arousal per hour of sleep. Participants with <=5 PLMAI were evaluated as responders.

Time Frame

Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

Adjusted Mean Change From Baseline in Sleep Quality at Week 4/10 as Measured by the Subjective Post Sleep Diary (SPSD) Using LOCF

Description

Time Frame

Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

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.

Description

Time Frame

Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

Adjusted Mean Change From Baseline in the Number of Awakenings Measured Objectively by Polysomnography at Week 4/10 Using LOCF

Description

Time Frame

Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

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

Description

Time Frame

Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

Number of Participants With no Self-reported Awakenings (SPSD) Due to RLS at Week 4/10 Using LOCF

Description

Time Frame

Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

Adjusted Mean Change From Baseline in the Total Sleep Time Measured by Polysomnography (PSG) at Week 4/10 Using LOCF

Description

Time Frame

Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

Adjusted Mean Change From Baseline in the Sleep Efficiency Measured by Polysomnography (PSG) at Week 4/10 Using LOCF

Description

Time Frame

Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

Adjusted Mean Change From Baseline in the Wake After Sleep Onset (WASO) Measured by Polysomnography (PSG) at Week 4/10 Using LOCF.

Description

Time Frame

Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

Adjusted Mean Change From Baseline in the Suggested Immobilization Test (SIT) PLM Index at Week 4/10

Description

Time Frame

Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

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

Description

Time Frame

Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

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

Description

Time Frame

Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

Adjusted Mean Change From Baseline in the Clinical Global Impression of Illness - Severity (CGI-S) Score at Week 4/10 Using LOCF

Description

Time Frame

Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

Number of Participants Who Were Defined as Clinical Global Impression of Illness (CGI-I) Scale "Responders" at Week 4/10 Using LOCF

Description

Time Frame

Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Title

Number of Participants Who Self-reported "Very Satisfied" or "Satisfied" With the Investigational Product at Week 4/10 Using LOCF

Description

Time Frame

Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Jasper

State/Province

Alabama

ZIP/Postal Code

35501

Country

United States

Facility Name

GSK Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

GSK Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92121

Country

United States

Facility Name

GSK Investigational Site

City

Hallandale Beach

State/Province

Florida

ZIP/Postal Code

33009

Country

United States

Facility Name

GSK Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

GSK Investigational Site

City

Macon

State/Province

Georgia

ZIP/Postal Code

31201

Country

United States

Facility Name

GSK Investigational Site

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66214

Country

United States

Facility Name

GSK Investigational Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66211

Country

United States

Facility Name

GSK Investigational Site

City

Crestview Hills

State/Province

Kentucky

ZIP/Postal Code

41017

Country

United States

Facility Name

GSK Investigational Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40509

Country

United States

Facility Name

GSK Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

Facility Name

GSK Investigational Site

City

Chevy Chase

State/Province

Maryland

ZIP/Postal Code

20815

Country

United States

Facility Name

GSK Investigational Site

City

Brighton

State/Province

Massachusetts

ZIP/Postal Code

02135

Country

United States

Facility Name

GSK Investigational Site

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49048

Country

United States

Facility Name

GSK Investigational Site

City

West Seneca

State/Province

New York

ZIP/Postal Code

14224

Country

United States

Facility Name

GSK Investigational Site

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27835

Country

United States

Facility Name

GSK Investigational Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

GSK Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45245

Country

United States

Facility Name

GSK Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44130

Country

United States

Facility Name

GSK Investigational Site

City

Dublin

State/Province

Ohio

ZIP/Postal Code

43017

Country

United States

Facility Name

GSK Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

GSK Investigational Site

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29201

Country

United States

Facility Name

GSK Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78756

Country

United States

Facility Name

GSK Investigational Site

City

Walla Walla

State/Province

Washington

ZIP/Postal Code

99362

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21733752

Citation

Calloway M, Bharmal M, Hill-Zabala C, Allen R. Development and validation of a subjective post sleep diary (SPSD) to assess sleep status in subjects with restless legs syndrome. Sleep Med. 2011 Aug;12(7):704-10. doi: 10.1016/j.sleep.2010.09.020. Epub 2011 Jul 5.

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

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

Restless Legs Syndrome, Restless Legs Syndrome (RLS)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial