Trial · NCT00748098
Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance
NCT00748098, Phase 3, Completed, XenoPort, Inc.; results first posted 2011-05-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance. Trials, record NCT00748098. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00748098
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance
- NCT number
- NCT00748098
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 136 participants, actual
- Lead sponsor
- XenoPort, Inc.
- Conditions
- Restless Legs Syndrome, Restless Legs Syndrome (RLS)
- Interventions
- GSK1838262 Extended Release Tablets, Placebo
- First posted
- 2008-09-08
- Last updated
- 2013-07-22
- Results first posted
- 2011-05-18
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | 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 | Adjusted Mean Change From Baseline in Periodic Limb Movements Associated With Arousal (PLMAI) at Week 4/10 as Measured by Polysomnography Using LOCF | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | 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. |
| Secondary | Adjusted Mean Change From Baseline in the International Restless Legs Rating Scale (IRLS) Total Score at Week 4/10 Using LOCF | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | 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. |
| Secondary | Adjusted Mean Change From Baseline in the Item 4 (Sleep Disturbance) Scores of the IRLS Rating Scale at Week 4/10 Using LOCF | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | 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. |
| Secondary | Adjusted Mean Change From Baseline in Time Spent in N1 Sleep as Measured by Polysomnography at Week 4/10 Using LOCF | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | 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. |
| 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 | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | 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. |
| Secondary | Adjusted Mean Change From Baseline in Time Spent in the N2 Sleep Stage as Measured by Polysomnography at Week 4/10 Using LOCF | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | 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. |
| Secondary | Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N2 Sleep Stage at Week 4/10 | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 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. |
| Secondary | Mean Change From Baseline in the Total Time Spent in Stage N3 Sleep Time at Week 4/10 Measured by PSG Using LOCF | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | 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. |
| Secondary | Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N3 Sleep Stage at Week 4/10 | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 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. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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) | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Periodic Limb Movements Associated With Arousal (PLMAI) at Week 4/10 as Measured by Polysomnography Using LOCF | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis. | limb movements per hour | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in the International Restless Legs Rating Scale (IRLS) Total Score at Week 4/10 Using LOCF | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. An additional 4 participants (2 in each treatment group) were excluded from the analysis due to missing/incomplete data. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in the Item 4 (Sleep Disturbance) Scores of the IRLS Rating Scale at Week 4/10 Using LOCF | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. An additional 4 participants (2 in each treatment group) were excluded from the analysis due to missing/incomplete data. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Time Spent in N1 Sleep as Measured by Polysomnography at Week 4/10 Using LOCF | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis. | minutes | LEAST_SQUARES_MEAN |
| 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 | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis. | percentage of total sleep time | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Time Spent in the N2 Sleep Stage as Measured by Polysomnography at Week 4/10 Using LOCF | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N2 Sleep Stage at Week 4/10 | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis. | percentage of total sleep time | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in the Total Time Spent in Stage N3 Sleep Time at Week 4/10 Measured by PSG Using LOCF | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N3 Sleep Stage at Week 4/10 | Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) | ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis. | percentage of total sleep time | LEAST_SQUARES_MEAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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) | Placebo | -6.02 | Standard Error 4.986 | minutes | |
| 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) | GEn 1200 mg | -32.02 | Standard Error 5.020 | minutes | |
| Adjusted Mean Change From Baseline in Periodic Limb Movements Associated With Arousal (PLMAI) at Week 4/10 as Measured by Polysomnography Using LOCF | Placebo | -1.52 | Standard Error 0.892 | limb movements per hour | |
| Adjusted Mean Change From Baseline in Periodic Limb Movements Associated With Arousal (PLMAI) at Week 4/10 as Measured by Polysomnography Using LOCF | GEn 1200 mg | -4.59 | Standard Error 0.899 | limb movements per hour | |
| Adjusted Mean Change From Baseline in the International Restless Legs Rating Scale (IRLS) Total Score at Week 4/10 Using LOCF | Placebo | -8.42 | Standard Error 0.713 | scores on a scale | |
| Adjusted Mean Change From Baseline in the International Restless Legs Rating Scale (IRLS) Total Score at Week 4/10 Using LOCF | GEn 1200 mg | -14.99 | Standard Error 0.725 | scores on a scale | |
| Adjusted Mean Change From Baseline in the Item 4 (Sleep Disturbance) Scores of the IRLS Rating Scale at Week 4/10 Using LOCF | Placebo | -1.47 | Standard Error 0.092 | scores on a scale | |
| Adjusted Mean Change From Baseline in the Item 4 (Sleep Disturbance) Scores of the IRLS Rating Scale at Week 4/10 Using LOCF | GEn 1200 mg | -2.27 | Standard Error 0.093 | scores on a scale | |
| Adjusted Mean Change From Baseline in Time Spent in N1 Sleep as Measured by Polysomnography at Week 4/10 Using LOCF | Placebo | -0.95 | Standard Error 1.508 | minutes | |
| Adjusted Mean Change From Baseline in Time Spent in N1 Sleep as Measured by Polysomnography at Week 4/10 Using LOCF | GEn 1200 mg | -6.19 | Standard Error 1.517 | minutes |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Treatment Intervention Period | STARTED | Placebo Followed by GEn 1200 mg/Day | 69 | |
| First Treatment Intervention Period | STARTED | GEn 1200 mg/Day Followed by Placebo | 67 | |
| First Treatment Intervention Period | COMPLETED | Placebo Followed by GEn 1200 mg/Day | 64 | |
| First Treatment Intervention Period | COMPLETED | GEn 1200 mg/Day Followed by Placebo | 66 | |
| First Treatment Intervention Period | NOT COMPLETED | Placebo Followed by GEn 1200 mg/Day | 5 | |
| First Treatment Intervention Period | NOT COMPLETED | GEn 1200 mg/Day Followed by Placebo | 1 | |
| First Taper Period | STARTED | Placebo Followed by GEn 1200 mg/Day | 64 | |
| First Taper Period | STARTED | GEn 1200 mg/Day Followed by Placebo | 66 | |
| First Taper Period | COMPLETED | Placebo Followed by GEn 1200 mg/Day | 61 | |
| First Taper Period | COMPLETED | GEn 1200 mg/Day Followed by Placebo | 65 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | Nervous system disorders | Placebo | 3 | 132 | 3 |
| other | Dizziness | Nervous system disorders | GEn 1200 mg | 26 | 127 | 26 |
| other | Headache | Nervous system disorders | Placebo | 9 | 132 | 9 |
| other | Headache | Nervous system disorders | GEn 1200 mg | 11 | 127 | 11 |
| other | Somnolence | Nervous system disorders | Placebo | 2 | 132 | 2 |
| other | Somnolence | Nervous system disorders | GEn 1200 mg | 16 | 127 | 16 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 5 | 132 | 5 |
| other | Dry mouth | Gastrointestinal disorders | GEn 1200 mg | 6 | 127 | 6 |
| other | Nausea | Gastrointestinal disorders | Placebo | 5 | 132 | 5 |
| other | Nausea | Gastrointestinal disorders | GEn 1200 mg | 6 | 127 | 6 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | GEn 1200 mg | ||
| Total, other adverse events | Placebo | 27 | 132 |
| Total, other adverse events | GEn 1200 mg | 54 | 127 |
| Total, serious adverse events | Placebo | 0 | 132 |
| Total, serious adverse events | GEn 1200 mg | 2 | 127 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21733752 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| GEn 1200 mg vs Placebo: Number of PLMAI Responders at Week 4/10 Using LOCF | Trial comparisons |
| GEn 1200 mg vs Placebo: Number of Participants Who Were Defined as Clinical Global Impression of Illness (CGI-I) Scale Responders at Week 4/10 Using LOCF | Trial comparisons |
| GEn 1200 mg vs Placebo: Number of Participants With no Self-reported Awakenings (SPSD) Due to RLS at Week 4/10 Using LOCF | Trial comparisons |
| GEn 1200 mg vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00748098
GET https://conductscience.org/api/trials/v1/NCT00748098/registered?page=2