Comparison · NCT01281202-9dd8baee
CPP-109 Vigabatrin Tablets vs Matching Placebo: Abstinence
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. CPP-109 Vigabatrin Tablets vs Matching Placebo: Abstinence. Trial comparisons, record NCT01281202-9dd8baee. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01281202-9dd8baee
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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 | 0.0485 | 0.0209 | 0.109 | wilson | |
| Risk in group 2 | 0.0865 | 0.0462 | 0.156 | wilson | |
| Risk difference, group 1 minus group 2 | -0.038 | -0.113 | 0.0344 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.561 | 0.195 | 1.62 | log | |
| Odds ratio, group 1 over group 2 | 0.539 | 0.174 | 1.67 | log | |
| Number needed to treat, for one fewer participant with the outcome on CPP-109 Vigabatrin Tablets than on Matching Placebo | 26.3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | CPP-109 Vigabatrin Tablets | Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase. During treatment, subjects received 3 CPP-109 Vigabatrin 500 mg Tablets, bid, for 9 weeks.~Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13) | 5 | 103 | OG000 |
| Group 2 | Matching Placebo | Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase. During Treatment, subjects received Vigabatrin matching placebo tablets, bid, for 9 weeks.~Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13) | 9 | 104 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Abstinence
- Description
- The number of subjects in each treatment group who are cocaine abstinent during the last 2 weeks of the Treatment Phase (Weeks 8 and 9).
- Time frame
- Weeks 8-9
- Population
Source ClinicalTrials.gov
Trial
- Title
- Vigabatrin for the Treatment of Cocaine Dependency
- NCT number
- NCT01281202
- Phases
- PHASE2, PHASE3
- Conditions
- Cocaine Addiction, Cocaine Dependence
- Interventions
- Vigabatrin, Matching Placebo
- Lead sponsor
- Catalyst Pharmaceuticals, Inc.
- Results first posted
- 2016-02-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01281202?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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