Comparison · NCT00365352-25d7b7bd
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
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. 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, record NCT00365352-25d7b7bd. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00365352-25d7b7bd
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.728 | 0.64 | 0.801 | wilson | |
| Risk in group 2 | 0.448 | 0.352 | 0.547 | wilson | |
| Risk difference, group 1 minus group 2 | 0.28 | 0.147 | 0.401 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.63 | 1.27 | 2.08 | log | |
| Odds ratio, group 1 over group 2 | 3.3 | 1.85 | 5.87 | log | |
| Number needed to treat, for one more participant with the outcome on GEn (XP13512/GSK1838262) 600 mg than on Placebo | 3.57 | 2.5 | 6.79 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | GEn (XP13512/GSK1838262) 600 mg | Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet. | 83 | 114 | OG001 |
| Group 2 | Placebo | Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet. | 43 | 96 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Classsified as Responders on the Investigator-rated CGI-I Scale at Week 12 Using LOCF
- Description
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.
- Time frame
- Week 12
- Population
- MITT Population. The number of participants assessed varies due to incomplete/missing data.
Source ClinicalTrials.gov
Trial
- Title
- XP13512 vs. Placebo in Patients With Restless Legs Syndrome.
- NCT number
- NCT00365352
- Phases
- PHASE3
- Conditions
- Restless Legs Syndrome
- Interventions
- XP13512 600MG, XP13512 1200MG, PLACEBO
- Lead sponsor
- XenoPort, Inc.
- Results first posted
- 2011-05-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00365352?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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