Comparison · NCT00365352-78046acd
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
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) 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, record NCT00365352-78046acd. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00365352-78046acd
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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 | 0.775 | 0.689 | 0.843 | wilson | |
| Risk in group 2 | 0.448 | 0.352 | 0.547 | wilson | |
| Risk difference, group 1 minus group 2 | 0.327 | 0.195 | 0.444 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.73 | 1.36 | 2.21 | log | |
| Odds ratio, group 1 over group 2 | 4.24 | 2.33 | 7.73 | log | |
| Number needed to treat, for one more participant with the outcome on GEn (XP13512/GSK1838262) 1200 mg than on Placebo | 3.06 | 2.25 | 5.12 | 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) 1200 mg | Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn). | 86 | 111 | 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
- PRIMARY
- Title
- 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
- Description
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.
- Time frame
- Week 12
- Population
- MITT Population
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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