Trial · NCT00365352
XP13512 vs. Placebo in Patients With Restless Legs Syndrome.
NCT00365352, Phase 3, Completed, XenoPort, Inc.; results first posted 2011-05-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. XP13512 vs. Placebo in Patients With Restless Legs Syndrome. Trials, record NCT00365352. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00365352
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- XP13512 vs. Placebo in Patients With Restless Legs Syndrome.
- NCT number
- NCT00365352
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 325 participants, actual
- Lead sponsor
- XenoPort, Inc.
- Conditions
- Restless Legs Syndrome
- Interventions
- XP13512 600MG, XP13512 1200MG, PLACEBO
- First posted
- 2006-08-17
- Last updated
- 2013-07-22
- Results first posted
- 2011-05-11
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in IRLS Rating Scale Total Score at Week 12 Using Last Observation Carried Forward (LOCF) | Baseline and Week 12 | The International Restless Legs Syndrome (IRLS) Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. 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. |
| Primary | Number of Participants With a Score of "Much Improved" or "Very Much Improved" on the Investigator-rated CGI-I Scale (Response) at (Week 12) Using LOCF | Week 12 | The investigator -rated Clinical Global Impression of Improvement (CGI-I) scale is an assessment designed to allow investigators to rate the change of a participant's disease severity over time based on a seven-point scale, with a score of 1 being "very much improved," a score of 2 being "much improved," a score of 3 being "minimally improved," a score of 4 being "no change," a score of 5 being "minimally improved,"a score of 6 being "much worse," and a score of 7 being "very much worse." Participants with a response of "much improved" or "very much improved" were classified as responders. |
| Secondary | Change From Baseline to the End of Treatment (Week 12) in the IRLS Rating Scale Total Score Using LOCF | Baseline (Day 1) and End of Treatment (Week 12) | The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. 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. |
| Secondary | Number of Participants Classsified as Responders on the Investigator-rated CGI-I Scale at Week 12 Using LOCF | Week 12 | The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as "Responders." |
| Secondary | Number of Participants Who Had an Onset of Response to Treatment at the End of Week 1 Based Upon the IRLS Rating Scale Total Score and the Investigator-rated CGI-I Using LOCF | End of Week 1 | The IRLS Rating scale is a measure of RLS disease severity. 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. Response was defined by an IRLS Rating Scale total score at the end of Week 1 \< 15 and at least a 6-point reduction from the participant's Baseline score and an investigator-rated CGI-I response of "much improved" or "very much improved." |
| Secondary | The Time to Onset of the First Response to Treatment on the IRLS Rating Scale Total Score and the Investigator-rated CGI-I | Baseline (Day 1) to End of Treatment (Week 12) | The Response was defined by an IRLS Rating Scale total score at the end of Week 1 \< 15 and at least a 6-point reduction from the participant's Baseline score and an investigator-rated CGI-I response of much improved or very much improved. The median time to onset is estimated using the product-limit estimation method. |
| Secondary | Mean Change in the IRLS Rating Scale Total Score From Baseline at Week 12 by RLS Treatment History Using LOCF | Baseline (Day 1) and Week 12 | The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. 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. |
| Secondary | Change From Baseline in the IRLS Rating Scale Total Score at Week 12 by Baseline RLS Rating Scale Total Score Category (Baseline RLS Severity) Using LOCF | Baseline (Day 1) and Week 12 | The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. 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. |
| Secondary | Change From Baseline to the End of Week 1 in the IRLS Rating Scale Total Score Using LOCF | Baseline and the End of Week 1 | The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. 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. |
| Secondary | Number of Participants Classified as Investigator-rated CGI-I Scale Responders at Week 12 by RLS Treatment History Using LOCF | Basline and Week 12 | The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as "Responders." |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in IRLS Rating Scale Total Score at Week 12 Using Last Observation Carried Forward (LOCF) | Baseline and Week 12 | Modified Intent-to-Treat (MITT) Population: all participants in the Safety Population who also satisfied all of the following conditions: (1) completed the IRLS Rating Scale at Baseline; and (2) completed at least one on-treatment IRLS Rating Scale score during the treatment period | scores on a scale | MEAN |
| PRIMARY | Number of Participants With a Score of Much Improved or Very Much Improved on the Investigator-rated CGI-I Scale (Response) at (Week 12) Using LOCF | Week 12 | MITT Population | participants | NUMBER |
| SECONDARY | Change From Baseline to the End of Treatment (Week 12) in the IRLS Rating Scale Total Score Using LOCF | Baseline (Day 1) and End of Treatment (Week 12) | MITT Population. The number of participants assessed varies due to incomplete/missing data. | scores on a scale | MEAN |
| SECONDARY | Number of Participants Classsified as Responders on the Investigator-rated CGI-I Scale at Week 12 Using LOCF | Week 12 | MITT Population. The number of participants assessed varies due to incomplete/missing data. | participants | NUMBER |
| SECONDARY | Number of Participants Who Had an Onset of Response to Treatment at the End of Week 1 Based Upon the IRLS Rating Scale Total Score and the Investigator-rated CGI-I Using LOCF | End of Week 1 | MITT Population. The number of participants assessed varies due to incomplete/missing data. | participants | NUMBER |
| SECONDARY | The Time to Onset of the First Response to Treatment on the IRLS Rating Scale Total Score and the Investigator-rated CGI-I | Baseline (Day 1) to End of Treatment (Week 12) | MITT Population. The number of participants assessed varies due to incomplete/missing data. | weeks | MEDIAN |
| SECONDARY | Mean Change in the IRLS Rating Scale Total Score From Baseline at Week 12 by RLS Treatment History Using LOCF | Baseline (Day 1) and Week 12 | MITT Population. The number of participants assessed varies due to incomplete/missing data. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in the IRLS Rating Scale Total Score at Week 12 by Baseline RLS Rating Scale Total Score Category (Baseline RLS Severity) Using LOCF | Baseline (Day 1) and Week 12 | MITT Population. The number of participants assessed varies due to incomplete/missing data. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline to the End of Week 1 in the IRLS Rating Scale Total Score Using LOCF | Baseline and the End of Week 1 | MITT Population. The number of participants assessed varies due to incomplete/missing data. | scores on a scale | MEAN |
| SECONDARY | Number of Participants Classified as Investigator-rated CGI-I Scale Responders at Week 12 by RLS Treatment History Using LOCF | Basline and Week 12 | Participants included in the MITT Population with a known RLS treatment history | participants | NUMBER |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group122
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in IRLS Rating Scale Total Score at Week 12 Using Last Observation Carried Forward (LOCF) | Placebo | -9.8 | Standard Deviation 7.69 | scores on a scale | |
| Change From Baseline in IRLS Rating Scale Total Score at Week 12 Using Last Observation Carried Forward (LOCF) | GEn (XP13512/GSK1838262) 1200 mg | -13.0 | Standard Deviation 9.12 | scores on a scale | |
| Number of Participants With a Score of Much Improved or Very Much Improved on the Investigator-rated CGI-I Scale (Response) at (Week 12) Using LOCF | Placebo | 43 | participants | ||
| Number of Participants With a Score of Much Improved or Very Much Improved on the Investigator-rated CGI-I Scale (Response) at (Week 12) Using LOCF | GEn (XP13512/GSK1838262) 1200 mg | 86 | participants | ||
| Change From Baseline to the End of Treatment (Week 12) in the IRLS Rating Scale Total Score Using LOCF | Placebo | -9.8 | Standard Deviation 7.69 | scores on a scale | |
| Change From Baseline to the End of Treatment (Week 12) in the IRLS Rating Scale Total Score Using LOCF | GEn (XP13512/GSK1838262) 600 mg | -13.8 | Standard Deviation 8.09 | scores on a scale | |
| Number of Participants Classsified as Responders on the Investigator-rated CGI-I Scale at Week 12 Using LOCF | Placebo | 43 | participants | ||
| Number of Participants Classsified as Responders on the Investigator-rated CGI-I Scale at Week 12 Using LOCF | GEn (XP13512/GSK1838262) 600 mg | 83 | participants | ||
| Number of Participants Who Had an Onset of Response to Treatment at the End of Week 1 Based Upon the IRLS Rating Scale Total Score and the Investigator-rated CGI-I Using LOCF | Placebo | 13 | participants | ||
| Number of Participants Who Had an Onset of Response to Treatment at the End of Week 1 Based Upon the IRLS Rating Scale Total Score and the Investigator-rated CGI-I Using LOCF | GEn (XP13512/GSK1838262) 600 mg | 36 | participants |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 97 | |
| Overall Study | STARTED | GEn (XP13512/GSK1838262) 600 mg | 115 | |
| Overall Study | STARTED | GEn (XP13512/GSK1838262) 1200 mg | 113 | |
| Overall Study | Safety Population | Placebo | 96 | |
| Overall Study | Safety Population | GEn (XP13512/GSK1838262) 600 mg | 115 | |
| Overall Study | Safety Population | GEn (XP13512/GSK1838262) 1200 mg | 111 | |
| Overall Study | Modified Intent-to-Treat Population | Placebo | 96 | |
| Overall Study | Modified Intent-to-Treat Population | GEn (XP13512/GSK1838262) 600 mg | 114 | |
| Overall Study | Modified Intent-to-Treat Population | GEn (XP13512/GSK1838262) 1200 mg | 111 | |
| Overall Study | COMPLETED | Placebo | 77 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events42
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 | Somnolence | Nervous system disorders | Placebo | 2 | 96 | |
| other | Somnolence | Nervous system disorders | GEn (XP13512/GSK1838262) 600 mg | 25 | 115 | |
| other | Somnolence | Nervous system disorders | GEn (XP13512/GSK1838262) 1200 mg | 20 | 111 | |
| other | Dizziness | Nervous system disorders | Placebo | 5 | 96 | |
| other | Dizziness | Nervous system disorders | GEn (XP13512/GSK1838262) 600 mg | 12 | 115 | |
| other | Dizziness | Nervous system disorders | GEn (XP13512/GSK1838262) 1200 mg | 27 | 111 | |
| other | Headache | Nervous system disorders | Placebo | 8 | 96 | |
| other | Headache | Nervous system disorders | GEn (XP13512/GSK1838262) 600 mg | 17 | 115 | |
| other | Headache | Nervous system disorders | GEn (XP13512/GSK1838262) 1200 mg | 15 | 111 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 7 | 96 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | GEn (XP13512/GSK1838262) 600 mg | ||
| Total, all-cause mortality | GEn (XP13512/GSK1838262) 1200 mg | ||
| Total, other adverse events | Placebo | 36 | 96 |
| Total, other adverse events | GEn (XP13512/GSK1838262) 600 mg | 68 | 115 |
| Total, other adverse events | GEn (XP13512/GSK1838262) 1200 mg | 64 | 111 |
| Total, serious adverse events | Placebo | 1 | 96 |
| Total, serious adverse events | GEn (XP13512/GSK1838262) 600 mg | 2 | 115 |
| Total, serious adverse events | GEn (XP13512/GSK1838262) 1200 mg | 0 | 111 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| GEn (XP13512/GSK1838262) 600 mg vs Placebo: Number of Participants Classsified as Responders on the Investigator-rated CGI-I Scale at Week 12 Using LOCF | Trial comparisons |
| GEn (XP13512/GSK1838262) 1200 mg vs Placebo: Number of Participants With a Score of Much Improved or Very Much Improved on the Investigator-rated CGI-I Scale (Response) at (Week 12) Using LOCF | 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/NCT00365352
GET https://conductscience.org/api/trials/v1/NCT00365352/registered?page=2