Comparison · NCT01228747-e68c77b5
Levetiracetam vs Placebo: Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period
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. Levetiracetam vs Placebo: Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period. Trial comparisons, record NCT01228747-e68c77b5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01228747-e68c77b5
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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 | 0.778 | 0.694 | 0.844 | wilson | |
| Risk in group 2 | 0.284 | 0.208 | 0.375 | wilson | |
| Risk difference, group 1 minus group 2 | 0.493 | 0.37 | 0.594 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.73 | 2 | 3.74 | log | |
| Odds ratio, group 1 over group 2 | 8.81 | 4.82 | 16.1 | log | |
| Number needed to treat, for one more participant with the outcome on Levetiracetam than on Placebo | 2.03 | 1.68 | 2.7 | 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 | Levetiracetam | Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily | 91 | 117 | OG001 |
| Group 2 | Placebo | Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily for 28 weeks | 31 | 109 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period
- Description
A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Treatment Period is considered a GTC 50 % responder.~Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline
- Time frame
- From Baseline to Week 28
- Population
Full Analysis Set consisted of all subjects in the SS who had an evaluable Baseline and at least 1 post-Baseline GTC seizure count data point for the primary efficacy analysis excluding those who had seriously violated GCP. Evaluable Baseline for the primary efficacy analysis: at least 1 GTC seizure was documented for the Combined Baseline.
Source ClinicalTrials.gov
Trial
- Title
- A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures)
- NCT number
- NCT01228747
- Phases
- PHASE3
- Conditions
- Epilepsy, Generalized Tonic-Clonic Seizures
- Interventions
- Levetiracetam, Placebo
- Lead sponsor
- UCB Japan Co. Ltd.
- Results first posted
- 2015-05-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01228747?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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