This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy (NCT00150709), a non-randomized phase 3 study. The primary outcome is Percentage Change From Baseline in Partial Onset (Type I) Seizure Frequency Per Week Over Time During the Treatment Period.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00150709 |
| Phase | Phase 3 |
| Condition | Epilepsy, Partial |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 223 |
| Arms in the primary outcome | n/a |
| Lead sponsor | UCB Pharma |
| Results posted | Yes |
2. Clinical Question
The study asked how seizure frequency and safety were described during long-term levetiracetam treatment in children with epilepsy who had participated in earlier levetiracetam studies. It was an open-label follow-up, not a randomized comparison of levetiracetam with placebo or another treatment. The registry lists partial-onset epilepsy as the condition and identifies the primary endpoint as change in partial-onset seizure frequency.
Population
Children with epilepsy who had participated in prior levetiracetam studies. The registry lists an enrollment of 223. The primary endpoint population was limited to participants with valid partial-onset seizure-frequency data at baseline and during treatment; data for the N01052 LEV/LEV group were unavailable for that endpoint because the prior study did not collect baseline seizure information.
Intervention
Levetiracetam during this open-label follow-up study, with monitoring and standardized follow-up care described in the registry summary.
Comparator
There was no randomized control group. The registry groups reflect participants’ treatment histories in earlier studies; they are not a like-for-like control comparison within this follow-up study.
Primary question
What was the median percentage change from baseline in weekly partial-onset seizure frequency during the treatment period, and what safety events were recorded during follow-up?
The registry’s primary outcome description defines negative percentage changes as improvement from baseline. It gives a treatment-period timeframe averaging 2 years, but the numerical primary endpoint results are not reported in the registry record. The listed outcomes therefore describe what the study set out to assess, not a basis for concluding how much seizure frequency changed or whether levetiracetam caused any change.
3. Trial Design
This was a Phase 3, multicenter, open-label, long-term follow-up study with non-randomized allocation and no masking. The registry classifies the model as single group and lists 223 participants enrolled. Its stated purpose was to let pediatric participants from earlier levetiracetam studies continue treatment with monitoring and standardized follow-up care until approval for use in children or completion of the pediatric development program.
The groups in the registry are distinguished by prior-study history. Participants in N159 PBO/LEV had received placebo in study N159; those in N159 LEV/LEV had received levetiracetam there. N01010+N151 LEV/LEV participants had received levetiracetam in study N01010 or N151, and N01052 LEV/LEV participants had received levetiracetam in study N01052. These labels describe previous exposure, not randomized assignments made in this follow-up study. The registry does not establish that the groups were comparable in baseline characteristics or prognosis.
The study started on 1998-01-26, had primary completion on 2006-01-25, and is listed as completed. The primary endpoint was percentage change from baseline in weekly partial-onset seizure frequency during treatment. Secondary outcomes included absolute changes in partial-onset and total seizure frequency, responder rates for those seizure categories, seizure-free measures, and time-interval summaries of continuous seizure freedom. The registry lists 91 outcome measures and 0 analyses. Numerical results for the primary endpoint are not reported in the registry record.
Because there was no randomized, concurrent comparison, observed changes over follow-up cannot by themselves separate treatment effects from changes over time, prior treatment history, or other influences. The registry record does not report a statistical analysis plan or a sample-size justification for the original study.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Participant Flow refers to the Intention-to-treat (ITT) Set.
Overall Study
| Stage | N159 PBO/LEV | N159 LEV/LEV | N01010+N151 LEV/LEV | N01052 LEV/LEV |
|---|---|---|---|---|
| STARTED | 79 | 89 | 41 | 14 |
| COMPLETED | 24 | 27 | 17 | 6 |
| NOT COMPLETED | 55 | 62 | 24 | 8 |
Reasons for not completing this period:
| Reason | N159 PBO/LEV | N159 LEV/LEV | N01010+N151 LEV/LEV | N01052 LEV/LEV |
|---|---|---|---|---|
| Protocol Violation | 7 | 8 | 3 | 1 |
| Adverse Event | 8 | 2 | 2 | 3 |
| Lack of Efficacy | 6 | 11 | 9 | 0 |
| Withdrawal by Subject | 7 | 10 | 5 | 0 |
| Lost to Follow-up | 3 | 2 | 0 | 0 |
| Sponsor decision | 0 | 0 | 0 | 1 |
| Site/Investigator discontinued the study | 5 | 5 | 2 | 0 |
| Decision of parent(s) | 1 | 2 | 0 | 0 |
| Decision of parent(s) and investigator | 3 | 0 | 0 | 0 |
| Loss/ incompleteness of efficacy | 12 | 12 | 2 | 2 |
| Investigator decision | 1 | 0 | 0 | 1 |
| Subject relocated | 2 | 2 | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Only subjects with valid data for Partial (Type I) seizure frequency at both baseline and during the treatment period are included in the analysis. The data for N01052 LEV/LEV arm was not available as the prior study N01052 did not collect baseline seizure information and therefore N01052 study participants were excluded systematically due to missing baseline measurements.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Baseline characteristics refer to the Intention-to-treat (ITT) Set which consisted of all subjects who took at least one dose of levetiracetam in study N157 excluding subjects from one site due to the unreliability of the data reported.
| Characteristic | Unit | N159 PBO/LEV | N159 LEV/LEV | N01010+N151 LEV/LEV | N01052 LEV/LEV | Total Title |
|---|---|---|---|---|---|---|
| Participants analysed | 79 | 89 | 41 | 14 | 223 | |
| Age, Categorical: <=18 years | Participants | 79 | 89 | 41 | 14 | 223 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous | years | 9.88 (SD 3.46) | 10.61 (SD 3.24) | 10.07 (SD 2.20) | 1.62 (SD 1.16) | 9.68 (SD 3.72) |
| Sex: Female, Male: Female | Participants | 43 | 39 | 16 | 7 | 105 |
| Sex: Female, Male: Male | Participants | 36 | 50 | 25 | 7 | 118 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage Change From Baseline in Partial Onset (Type I) Seizure Frequency Per Week Over Time During the Treatment Period, measured over During the Treatment Period (an average of 2 years), compared to Baseline.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | percentage of change |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was percentage change from baseline in partial-onset (Type I) seizure frequency per week during the treatment period. Seizure frequency was standardized to a one-week period, allowing observations over the treatment period to be expressed on the same weekly scale. The registry describes the treatment period as averaging 2 years and specifies comparison with baseline.
The registry identifies the median as the summary measure and the interquartile range as the dispersion measure. The median describes the middle of the observed distribution, while the interquartile range describes the spread of its central portion. These summaries can be useful when individual changes vary substantially or the distribution is not well represented by a mean and standard deviation. This is a general statistical explanation; it does not establish the distribution of this study’s endpoint values.
The direction is explicitly defined: negative values indicate improvement from baseline. Interpretation still depends on the actual estimate and its spread. Those numerical results are not reported in the registry record, so the direction and magnitude of the observed primary endpoint cannot be described from the registry information available. The endpoint population required valid partial-onset seizure-frequency data at both baseline and during treatment. The N01052 LEV/LEV data were unavailable for this analysis because the prior study did not collect baseline seizure information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a long-term follow-up study of levetiracetam exposure in children, not a randomized efficacy comparison. Its primary endpoint was intended to summarize change in weekly partial-onset seizure frequency from baseline during treatment. The outcome was to be summarized by a median and interquartile range, with negative changes defined as improvement. However, the numerical primary endpoint estimate and its interquartile range are not reported in the registry record. The record therefore does not support a description of the size, direction, or precision of the primary endpoint result.
The four listed groups are defined by treatment received in prior studies. In particular, the N159 PBO/LEV label indicates prior placebo exposure followed by levetiracetam in this follow-up context; the other labels identify prior levetiracetam exposure in their respective studies. These histories do not create a randomized control group in the present study. Differences between groups could reflect prior study membership, previous treatment, eligibility, follow-up, or other differences. The registry does not report enough information to assess or adjust for such factors.
A before-and-during-treatment comparison can describe how seizure frequency changed among participants with usable measurements, but it does not alone establish why it changed. General considerations include natural fluctuation in seizure frequency, changes in observation or reporting, and differences in who contributes measurements over time. These are possible interpretation issues for an uncontrolled follow-up design, not findings reported about this study. The registry does not report an analysis that resolves them.
The primary endpoint population excludes participants without valid measurements at both baseline and during treatment. In addition, the N01052 LEV/LEV data were unavailable for the endpoint because the prior study did not collect baseline seizure information. This makes the primary endpoint population narrower than the full enrollment, although the registry record does not give the primary endpoint analysis count. The amount and pattern of missing data among other participants are not reported in the registry record.
The safety information gives counts of participants at risk and affected for serious and other adverse events within each prior-study group, as well as deaths and selected serious-event terms. These counts are descriptive. They do not establish comparative safety because the study was non-randomized, the groups differ by treatment history, and no randomized comparator is present. The registry does not provide a causal comparison or numerical primary outcome results alongside which to interpret safety and efficacy jointly.
Accordingly, the registry record documents the study’s design, intended outcomes, and selected safety counts, but it does not report the numerical primary endpoint result. Any planning illustrations based on an observed effect are not evidence of observed power and are not the original design’s sample-size justification. The sponsor’s own analysis is not reported in the registry record, so no sponsor estimate can be set against a recalculation.
9. Statistical Methods Explained
The methods described in the registry are limited. It identifies a median and interquartile range for the primary endpoint, defines the endpoint population, and lists secondary outcomes. It does not report the numerical primary estimate, a confidence interval, a formal test, or an analysis plan. The explanations below describe general statistical ideas and do not imply that any particular unreported method was used.
What does a median and interquartile range convey?
For a set of participant-level changes, the median is the central value after ordering the observations. The interquartile range represents the interval between the lower and upper quartiles and gives a sense of the spread among the central observations. Together, these summaries describe both a typical value and variability without requiring that the distribution be symmetric. They do not show every participant’s experience, and they are not a substitute for an uncertainty interval for a treatment effect. The registry specifies this summary approach but does not report the resulting values.
How should the change-from-baseline endpoint be read?
A change-from-baseline endpoint compares a participant’s measurement during treatment with that participant’s baseline measurement. The registry defines the primary measure as percentage change in weekly partial-onset seizure frequency and states that negative values indicate improvement. That sign convention is important: interpretation should follow the endpoint’s stated direction rather than assume that positive and negative values have a universal meaning. The registry also requires valid data at baseline and during treatment for inclusion in the primary endpoint population.
Change from baseline can be informative as a description of within-participant change. In general, however, a before-and-after contrast does not by itself identify a causal treatment effect. Without a randomized concurrent comparator, other time-related influences may contribute to the observed change. This is a design limitation, not a claim that such influences occurred in this study.
Why does the study structure matter?
Randomization is used in general to help create groups comparable, on average, with respect to factors that might affect outcomes. This study is recorded as non-randomized, open-label, and single group. Its listed groups are based on previous study and treatment histories, rather than current random allocation. Consequently, comparisons between those groups should not be interpreted as though one group were a randomized control for another. The registry explicitly cautions that the arms are not a like-for-like control comparison.
Open-label means masking was absent, as recorded for this study. In general, knowledge of treatment can affect reporting, assessment, or care. The registry does not describe whether any particular measurement or decision was affected in this way. It also does not report a blinding procedure or a statistical adjustment intended to address potential differences.
What do the planning illustrations mean?
The registry’s planning assumptions describe an illustration based on an observed effect, rather than the trial’s own design. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. For time-to-event outcomes, the illustration uses the total number of events under the Schoenfeld approach; for other outcomes, it gives participants per arm.
These are planning concepts, not observed results. A sample-size illustration asks how many participants or events might be needed under specified assumptions to detect a target effect. It is not an estimate of the probability that the completed study detected an effect, and it is not observed power. The registry record does not report an original sample-size justification or protocol rationale for the enrollment. No planning value should be treated as proof that the study was adequately powered for its outcomes.
Why can variation exceed a simple model’s expectations?
In general, over-dispersion means the observed variability is greater than a statistical model expects. If a model understates variation, uncertainty estimates may be too narrow and tests may appear more decisive than warranted. This concept is relevant to repeated or count-like outcomes such as seizure frequencies, but the registry does not report a model for this endpoint or evidence that over-dispersion was assessed. It would therefore be inappropriate to attribute a particular model or correction to the study.
More generally, outcome estimates need both a clear population definition and a description of uncertainty. The registry defines an endpoint population requiring valid data at baseline and during treatment, but does not report the number analyzed or a confidence interval. Without those results, the precision of the primary estimate cannot be assessed from the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 91 outcome measures, including the primary seizure-frequency endpoint and secondary outcomes covering absolute seizure-frequency changes, responder rates, seizure-free status, and time intervals of continuous seizure freedom. It records 0 analyses. The registry record does not report how the listed outcomes were prioritized beyond naming the primary endpoint, or whether any multiplicity adjustment was planned or used.
Multiplicity is a general concern when many outcomes or repeated comparisons are examined. The more questions assessed, the greater the chance that some result may appear notable by chance alone if each is interpreted separately. Statistical approaches can control or describe that issue, but the registry record does not specify an approach. The number of listed outcomes alone does not reveal how many were analyzed or whether any formal adjustment was applied.
The primary endpoint analysis population required valid partial-onset seizure-frequency data at baseline and during treatment. The registry specifically states that data for N01052 LEV/LEV were unavailable because the previous study did not collect baseline seizure information. The primary endpoint analysis count and the handling of other missing observations are not reported in the registry record. Imputation, sensitivity analyses, and rules for incomplete follow-up are also not reported in the registry record.
The registry does not report a full statistical analysis plan, including interim analyses, model specifications, covariate adjustment, or the treatment of repeated measurements. The record’s endpoint definition and summary statistics do not establish that these methods were used. As a result, the interpretation is constrained to the design description, outcome definitions, and safety counts that the registry reports.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| N159 PBO/LEV | 20 | 79 | 25.3% |
| N159 LEV/LEV | 35 | 89 | 39.3% |
| N01010+N151 LEV/LEV | 12 | 41 | 29.3% |
| N01052 LEV/LEV | 7 | 14 | 50.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| N159 PBO/LEV | 0 of 79 |
| N159 LEV/LEV | 1 of 89 |
| N01010+N151 LEV/LEV | 0 of 41 |
| N01052 LEV/LEV | 0 of 14 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| N159 PBO/LEV | 77 of 79 |
| N159 LEV/LEV | 86 of 89 |
| N01010+N151 LEV/LEV | 41 of 41 |
| N01052 LEV/LEV | 13 of 14 |
Most frequent serious adverse event terms
| Event term | Organ system | N159 PBO/LEV | N159 LEV/LEV | N01010+N151 LEV/LEV | N01052 LEV/LEV |
|---|---|---|---|---|---|
| Convulsion | Nervous system disorders | 9 of 79 | 7 of 89 | 2 of 41 | 4 of 14 |
| Procedure therapeutic epilepsy | Investigations | 2 of 79 | 8 of 89 | 5 of 41 | 0 of 14 |
| Procedure diagnostic epilepsy | Investigations | 2 of 79 | 9 of 89 | 1 of 41 | 0 of 14 |
| Procedure diagnostic | Investigations | 1 of 79 | 1 of 89 | 2 of 41 | 0 of 14 |
| Gasteroenteritis | Gastrointestinal disorders | 0 of 79 | 3 of 89 | 0 of 41 | 0 of 14 |
| Depression | Nervous system disorders | 1 of 79 | 2 of 89 | 0 of 41 | 0 of 14 |
| Personality disorder | Nervous system disorders | 0 of 79 | 3 of 89 | 0 of 41 | 0 of 14 |
| Status epilepticus | Nervous system disorders | 1 of 79 | 1 of 89 | 0 of 41 | 1 of 14 |
| Procedure therapeutic | Investigations | 1 of 79 | 2 of 89 | 0 of 41 | 0 of 14 |
| Fever | General disorders | 0 of 79 | 1 of 89 | 1 of 41 | 0 of 14 |
Most frequent non-serious adverse event terms
| Event term | Organ system | N159 PBO/LEV | N159 LEV/LEV | N01010+N151 LEV/LEV | N01052 LEV/LEV |
|---|---|---|---|---|---|
| Infection | General disorders | 46 of 79 | 48 of 89 | 20 of 41 | 10 of 14 |
| Fever | General disorders | 24 of 79 | 23 of 89 | 9 of 41 | 7 of 14 |
| Headache | General disorders | 19 of 79 | 23 of 89 | 15 of 41 | 0 of 14 |
| Accidental injury | General disorders | 18 of 79 | 26 of 89 | 9 of 41 | 3 of 14 |
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | 21 of 79 | 20 of 89 | 11 of 41 | 3 of 14 |
| Otitis media | Ear and labyrinth disorders | 17 of 79 | 19 of 89 | 9 of 41 | 7 of 14 |
| Somnolence | Nervous system disorders | 20 of 79 | 18 of 89 | 10 of 41 | 3 of 14 |
| Vomiting | Gastrointestinal disorders | 15 of 79 | 16 of 89 | 11 of 41 | 4 of 14 |
| Rhinitis | Respiratory, thoracic and mediastinal disorders | 12 of 79 | 16 of 89 | 10 of 41 | 4 of 14 |
| Insomnia | Nervous system disorders | 11 of 79 | 14 of 89 | 6 of 41 | 0 of 14 |
Serious events with the highest arm-level rate: convulsion (28.6%), procedure therapeutic epilepsy (12.2%), procedure diagnostic epilepsy (10.1%), cyst (7.1%), hypothermia (7.1%).
The registry reports serious adverse events and other adverse events by prior-study group. For N159 PBO/LEV, 79 participants were at risk for each category; 20 were affected by serious adverse events and 77 by other adverse events, with 0 deaths. For N159 LEV/LEV, 89 were at risk; 35 were affected by serious adverse events and 86 by other adverse events, with 1 death. For N01010+N151 LEV/LEV, 41 were at risk; 12 were affected by serious adverse events and 41 by other adverse events, with 0 deaths. For N01052 LEV/LEV, 14 were at risk; 7 were affected by serious adverse events and 13 by other adverse events, with 0 deaths.
The registry also lists serious-event terms and their reported percentages: Convulsion, 28.6%; Procedure therapeutic epilepsy, 12.2%; Procedure diagnostic epilepsy, 10.1%; Cyst, 7.1%; Hypothermia, 7.1%; and Infection, 7.1%. These are reported terms, not a comparison of treatment risks.
These figures are descriptive counts within groups defined by prior study history. They should not be treated as randomized comparisons or causal estimates. The registry record does not provide adjusted safety comparisons or enough information to determine whether the groups had comparable follow-up or characteristics.
12. What the Result Does, and Does Not, Mean
The study’s design and outcome definitions establish what the registry intended to describe: long-term follow-up during levetiracetam treatment in children with epilepsy, with seizure frequency and safety among the outcomes. The primary measure concerns percentage change from baseline in weekly partial-onset seizure frequency. The registry defines negative values as improvement and specifies a median with interquartile range.
Those definitions do not reveal the result. The numerical primary endpoint estimate and its dispersion are not reported in the registry record. Without them, the direction and size of the observed change cannot be stated, and its precision cannot be evaluated. The same caution applies to the secondary outcomes: their names are listed, but numerical results are not reported in the registry record.
The non-randomized, open-label follow-up design also limits what a change from baseline can establish. A descriptive change among participants with available observations is not equivalent to a randomized treatment effect. The groups reflect earlier study histories, and the registry states that they are not a like-for-like control comparison. Differences between these groups cannot be attributed to levetiracetam on the basis of the recorded design alone.
The safety counts indicate how many participants were recorded as affected in each group and list selected serious-event terms. They are not, by themselves, evidence that an event was caused by treatment or that one group had a greater treatment-related risk. The record does not report a randomized safety comparison or adjusted analysis.
In short, the registry supports a description of the study’s purpose, design, endpoint definitions, analysis-population restriction, and reported safety counts. It does not support a numerical conclusion about the primary seizure-frequency result, a causal efficacy estimate, or a comparative safety effect. This distinction separates what the study was designed to monitor from what the posted registry results actually quantify.
13. Why This Trial Matters Statistically
This trial is statistically notable as a long-term follow-up study rather than a conventional randomized comparison. Its purpose was to continue treatment and standardized follow-up care for pediatric participants who had taken part in earlier levetiracetam studies. That setting is useful for understanding the kinds of longitudinal outcomes the registry tracked, while also making the distinction between monitoring and causal comparison especially important.
The primary endpoint illustrates why definitions matter. The registry specifies weekly partial-onset seizure frequency, percentage change from baseline, a median and interquartile range, and a direction in which negative values indicate improvement. These details allow a reader to understand how a result would be interpreted. But the numerical result itself is not reported in the registry record, so the endpoint definition cannot stand in for an observed estimate.
The population restriction is also consequential. Valid baseline and treatment-period data were required for the primary endpoint, and the N01052 LEV/LEV group’s data were unavailable because the earlier study did not collect baseline seizure information. This makes clarity about analysis populations and missing baseline information important when reading long-term follow-up data.
Finally, the study demonstrates why treatment-history groups should not automatically be treated as controls. The registry records non-randomized allocation and explicitly states that the groups are not a like-for-like control comparison. For biostatistical interpretation, the design determines what contrasts can support; a well-defined endpoint or a long observation period cannot by itself replace randomization or a reported comparative analysis.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The central limitation is the absence of a randomized concurrent control group. Although the registry lists four groups, they are defined by participants’ previous study and treatment histories. The record cautions that they are not a like-for-like control comparison. Comparisons among them therefore cannot be read as randomized estimates of treatment effect.
The study was open-label with no masking. The registry does not report whether outcome assessment was independently masked or how seizure information was collected. The record also does not describe a plan to account for possible differences in reporting, assessment, or follow-up over time.
The primary endpoint requires valid measurements at baseline and during treatment. The N01052 LEV/LEV group had no baseline seizure information from its prior study and was unavailable for this endpoint. The number of participants contributing to the primary analysis, missingness among other participants, and methods for handling incomplete data are not reported in the registry record.
Most importantly for interpreting results, the numerical primary endpoint estimate and its interquartile range are not reported in the registry record. Numerical findings for the listed secondary outcomes are also not reported in the registry record. The record lists 91 outcome measures and 0 analyses, but does not report multiplicity handling, a complete statistical analysis plan, or interim-analysis procedures.
The registry gives safety counts by group but does not report adjusted or randomized safety comparisons. The duration and completeness of individual follow-up are not described in the information recorded here, and the study’s original sample-size justification is not reported in the registry record. These limitations restrict conclusions to the design description and descriptive safety information that the registry reports.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy — NCT00150709.
- Registry record last updated 2024-02-09; status last verified 2023-06.
- Results first posted 2024-02-09.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT00150709 is a completed Phase 3, multicenter, open-label, non-randomized, single-group long-term follow-up study of levetiracetam in children with epilepsy. The registry lists 223 participants enrolled. Its purpose was to support continued treatment, monitoring, and standardized follow-up care for participants from earlier pediatric levetiracetam studies.
The primary endpoint was median percentage change from baseline in weekly partial-onset seizure frequency during treatment, with interquartile range as the dispersion measure. Negative values were defined as improvement. The primary endpoint population required valid baseline and treatment-period data; N01052 LEV/LEV data were unavailable because the prior study did not collect baseline seizure information. Numerical primary results are not reported in the registry record.
Safety information is reported by prior-study group as affected participant counts, with selected serious-event terms and deaths. Because allocation was not randomized and the groups are not like-for-like controls, these counts do not establish comparative treatment effects.