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 Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures (NCT00490035), a randomized phase 3 study. The primary outcome is Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00490035 |
| Phase | Phase 3 |
| Condition | Epilepsy |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 399 |
| Arms in the primary outcome | 4 |
| Lead sponsor | UCB Pharma SA |
| Results posted | Yes |
2. Clinical Question
Population
Participants were subjects aged at least 16 through 70 years with partial onset seizures. The registry record defines the intention-to-treat population as all randomized subjects who received at least 1 dose of study medication. The trial enrolled 399 participants overall.
Intervention
Participants received brivaracetam at 20 mg/day, 50 mg/day, or 100 mg/day. Each daily dose was administered twice a day: 10 mg, 25 mg, or 50 mg at each administration, respectively.
Comparator
The control group received matching placebo tablets administered twice a day. The study was randomized and placebo controlled.
Primary question
The primary endpoint was the median frequency of partial onset seizures classified as Type I, measured per week from baseline to the 12-week treatment period. The sponsor reported an ANCOVA comparison of brivaracetam 50 mg/day with placebo, expressed as percentage reduction over placebo. The registry record does not report sponsor analyses for the other brivaracetam doses on this endpoint.
3. Trial Design
This was a phase 3, randomized, parallel-group, placebo-controlled study sponsored by UCB Pharma SA. The record describes the study as double-blind in its title and lists masking as quadruple. It does not report which specific trial roles were included in that masking designation. The study was completed; the registry record lists its start as 2007-09 and primary completion as 2009-02.
There were four arms: matching placebo and brivaracetam 20 mg/day, 50 mg/day, and 100 mg/day. The stated daily brivaracetam doses were divided into twice-daily administrations. The enrollment was 399. The registry record defines the intention-to-treat population as all randomized subjects who received at least 1 dose of study medication. It does not report arm-specific allocation procedures, the randomization sequence, or details of concealment.
The planned treatment assessment period for the primary endpoint was 12 weeks. The primary measure was the weekly frequency of Type I partial onset seizures, summarized by the median and inter-quartile range. The registry record also lists secondary seizure outcomes, quality-of-life outcomes, and other measures over the treatment period. The full protocol, detailed eligibility criteria beyond the stated seizure condition and age range, and the sample-size justification are not reported in the registry record. The posted planning illustrations are calculations based on observed effects, not documentation of the trial’s original design assumptions.
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 Randomized Set.
Overall Study
| Stage | Placebo | Brivaracetam 20 mg/Day | Brivaracetam 50 mg/Day | Brivaracetam 100 mg/Day |
|---|---|---|---|---|
| STARTED | 100 | 99 | 100 | 100 |
| COMPLETED | 92 | 93 | 88 | 94 |
| NOT COMPLETED | 8 | 6 | 12 | 6 |
Reasons for not completing this period:
| Reason | Placebo | Brivaracetam 20 mg/Day | Brivaracetam 50 mg/Day | Brivaracetam 100 mg/Day |
|---|---|---|---|---|
| AE, non-serious non-fatal | 3 | 4 | 4 | 5 |
| Lost to Follow-up | 2 | 0 | 1 | 0 |
| Withdrawal by Subject | 2 | 1 | 1 | 0 |
| Other reason | 0 | 1 | 3 | 1 |
| AE, serious fatal | 1 | 0 | 0 | 0 |
| Serious adverse event (SAE), non-fatal | 0 | 0 | 1 | 0 |
| AE of unknown type | 0 | 0 | 2 | 0 |
Analysis population for the primary outcome, as defined in the registry: The Intention-to-treat (ITT) population was defined as all randomized subjects who received at least 1 dose of study medication.
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 Randomized Set.
| Characteristic | Unit | Placebo | Brivaracetam 20 mg/Day | Brivaracetam 50 mg/Day | Brivaracetam 100 mg/Day | Total Title |
|---|---|---|---|---|---|---|
| Participants analysed | 100 | 99 | 100 | 100 | 399 | |
| Age, Continuous | years | 36.4 (SD 13.0) | 35.7 (SD 12.5) | 39.0 (SD 13.5) | 38.0 (SD 13.1) | 37.24 (SD 13.05) |
| Age, Customized: <18 years | participants | 2 | 2 | 0 | 1 | 5 |
| Age, Customized: Between 18 and 65 years | participants | 96 | 94 | 97 | 96 | 383 |
| Age, Customized: >=65 years | participants | 2 | 3 | 3 | 3 | 11 |
| Sex: Female, Male: Female | Participants | 46 | 38 | 45 | 42 | 171 |
| Sex: Female, Male: Male | Participants | 54 | 61 | 55 | 58 | 228 |
| Region of Enrollment: Hungary | Participants | 4 | 2 | 3 | 3 | 12 |
| Region of Enrollment: Poland | Participants | 26 | 28 | 27 | 27 | 108 |
| Region of Enrollment: India | Participants | 23 | 22 | 23 | 23 | 91 |
| Region of Enrollment: Belgium | Participants | 3 | 0 | 3 | 0 | 6 |
| Region of Enrollment: Finland | Participants | 3 | 3 | 1 | 4 | 11 |
| Region of Enrollment: France | Participants | 17 | 17 | 11 | 15 | 60 |
| Region of Enrollment: Germany | Participants | 8 | 10 | 14 | 9 | 41 |
| Region of Enrollment: Italy | Participants | 4 | 8 | 3 | 5 | 20 |
| Region of Enrollment: Netherlands | Participants | 3 | 0 | 1 | 3 | 7 |
| Region of Enrollment: Spain | Participants | 8 | 4 | 6 | 4 | 22 |
6. Primary Endpoint
The registry lists the primary outcome as Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period, measured over From Baseline to 12-week Treatment Period.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | Seizure Frequency per Week |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint measures how often participants experienced partial onset seizures classified as Type I. The registry description includes simple partial seizures, complex partial seizures, and partial seizures evolving to secondarily generalized seizures in this classification. Frequency is expressed per week, with the measurement described from baseline to the 12-week treatment period.
The registry reports a median for each arm, accompanied by an inter-quartile range. A median describes the central observation in the distribution and is less affected by extreme values than a mean. The inter-quartile range describes the middle portion of the observed distribution; a broad range indicates more variability among participants’ seizure frequencies. These summaries describe each arm, but they do not by themselves estimate an adjusted treatment contrast or establish how precisely the arms differ.
General: seizure counts can be unevenly distributed, with many participants having relatively low counts and some having much higher counts. A median can be useful when a mean would be strongly influenced by unusually high counts. The endpoint is clinically interpretable as seizure frequency, but the registry record does not provide participant-level distributions or enough details to assess the assumptions behind a particular count-data model.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary arm summaries show medians of 1.75 seizures per week for placebo, 1.34 for brivaracetam 20 mg/day, 1.49 for brivaracetam 50 mg/day, and 1.26 for brivaracetam 100 mg/day. The corresponding inter-quartile ranges are 0.76 to 5.12, 0.7 to 3.12, 0.69 to 2.78, and 0.52 to 2.93. These are descriptive summaries; they do not alone show whether a difference between treatment groups is distinguishable from random variation.
The sponsor’s reported primary comparison is for brivaracetam 50 mg/day versus placebo. It reports a percentage reduction over placebo of 6.5, with a 95% confidence interval from -5.2 to 16.9 and p = 0.261. The interval includes zero, so the reported data do not establish a clear difference for this comparison under the sponsor’s analysis. The interval also spans effects in either direction, meaning the estimate is not precise enough to rule out a range of possibilities. The registry record does not provide sponsor-reported primary comparisons for the 20 mg/day or 100 mg/day arms.
The sponsor’s comparison is not simply a subtraction of the arm medians. It is reported as an ANCOVA estimate on the percentage-reduction scale. The adjustment variables, model details, and exact analysis population for this reported comparison are not reported in the registry record. As a result, readers should distinguish the arm-level medians from the sponsor’s adjusted comparison rather than treating them as interchangeable estimates.
Selected secondary outcomes include a seizure-type frequency ratio and changes in QOLIE-31-P scores. The registry also lists other seizure-frequency, responder, seizure-freedom, and time-to-event outcomes. The secondary summaries and recalculated comparisons are exploratory in interpretation: they are not a substitute for the prespecified primary analysis, and unadjusted comparisons do not account for the number of outcomes and contrasts examined. The record does not report a multiplicity adjustment for those outcomes.
Overall, the posted primary data consist of descriptive arm summaries and one sponsor-reported adjusted comparison. They provide a point estimate with an interval that remains compatible with a range of possible effects. They do not justify treating a single p-value as a complete description of uncertainty, and they do not establish that the same pattern applies across all doses or secondary measures.
9. Statistical Methods Explained
The endpoint is summarized by the median and inter-quartile range rather than the mean and standard deviation. The median represents the center of the observed values, while the inter-quartile range describes their spread around that center. General: this summary can be useful when observations are skewed or include unusually high values. It is descriptive, however, and does not by itself adjust for baseline differences or provide a direct inferential comparison between randomized groups.
What does the sponsor’s ANCOVA estimate describe?
The registry reports an ANCOVA comparison for brivaracetam 50 mg/day versus placebo, with the result expressed as percentage reduction over placebo. ANCOVA is a regression-based approach that can compare groups while accounting for specified covariates. General: adjustment can improve precision or address chance baseline imbalance when appropriate covariates and model assumptions are specified. The registry record does not identify the covariates, model specification, or missing-data handling for this ANCOVA, so those details cannot be evaluated from the posted result.
The sponsor reports an estimate of 6.5, a 95% confidence interval from -5.2 to 16.9, and p = 0.261. A confidence interval gives a range of values compatible with the observed data under the model and its assumptions. It communicates uncertainty about the estimated effect rather than the probability that a treatment effect is true. The interval includes zero, and its width indicates that the estimate does not pinpoint a narrow range of possible effects. A p-value describes how unusual data at least as incompatible with the null hypothesis would be under that hypothesis and the analysis assumptions; it is not a measure of effect size or clinical importance.
Why are the recalculated comparisons different?
Some secondary comparisons are recalculated from the posted group summaries. These are simple, unadjusted comparisons and should not be read as the sponsor’s model-based analyses. For binary outcomes, the recalculated risk difference contrasts the observed proportions in two groups. For continuous outcomes, the recalculated mean difference contrasts the posted group means. The confidence intervals express uncertainty for those unadjusted estimates. The registry record lists no sponsor-reported analyses for the secondary outcomes described in the numerical results.
General: an unadjusted comparison may differ from a prespecified analysis that adjusts for baseline values, uses a different analysis population, or applies a model suited to the outcome distribution. The record does not contain the details needed to reproduce the sponsor’s analysis or reconcile it with a simple recalculation. These recalculations therefore serve as transparent descriptions of the posted summaries, not as replacements for the sponsor’s analysis.
What do the planning illustrations mean?
The planning illustrations use the observed effect as a starting point and show participant counts per arm for stated fractions of that observed effect, under the listed assumptions: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They are prospective planning examples, not observed power and not evidence that the original trial was designed using those assumptions. Smaller target effects generally require larger planned samples under otherwise similar assumptions; that is a general statistical relationship, not a separate result from this trial. The trial’s own sample-size justification is not reported in the registry record.
General: power is a design property calculated under a specified effect, variability, analysis method, and significance threshold. It does not measure the probability that a particular observed result is correct. Because planning illustrations based on an observed effect inherit uncertainty from that estimate, they should not be treated as definitive sample-size recommendations. The registry record does not report the original assumptions, anticipated effect, or planned power for this trial.
Why do outcome distributions matter?
Seizure counts may vary substantially among participants. General: when count data are more variable than a simple model assumes, over-dispersion can make standard errors too small if it is ignored, leading to confidence intervals that are too narrow. Methods designed for over-dispersed counts can account for this extra variability, but the registry record does not state which count-data model, if any, was used for the primary outcome. The sponsor’s reported ANCOVA result is described by its method name, but further model details are not reported.
The posted arm summaries and sponsor estimate therefore answer related but distinct questions: the summaries show the observed median frequency and spread within each arm, while the reported ANCOVA gives the sponsor’s modeled comparison for one dose against placebo. Interpreting the latter depends on analysis details that are not reported in the registry record.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| ANCOVA | Percentage Reduction over Placebo 6.5 | -5.2 to 16.9 | =0.261 |
The sponsor’s reported primary analysis compares brivaracetam 50 mg/day with placebo using ANCOVA. The estimated percentage reduction over placebo is 6.5, with a 95% confidence interval from -5.2 to 16.9 and p = 0.261. The interval includes zero and spans estimates on both sides of it, so the result is uncertain about the direction and size of the comparison. The p-value is consistent with that uncertainty; it should not be interpreted as the probability that the null hypothesis is true.
The arm summaries report medians and inter-quartile ranges, whereas the sponsor’s result is an adjusted comparison expressed as percentage reduction over placebo. They are not the same estimand and should not be compared as if one were a direct recalculation of the other. No recalculated two-arm estimate is available from the posted median summaries. The registry record does not report sponsor analyses for the other two brivaracetam doses on the primary endpoint, nor does it specify the ANCOVA covariates, missing-data procedure, or model details. The reported sponsor analysis is therefore the available inferential result for the primary endpoint, while the arm medians remain descriptive context.
11. Multiplicity, Missing Data and Analysis Populations
The registry record lists 23 outcome measures and 22 posted secondary outcomes. It reports one analysis for the primary endpoint and does not provide a multiplicity-adjustment plan for the secondary outcomes. When many endpoints and treatment contrasts are examined, the chance of observing an apparently unusual result can increase. General: adjusting for multiplicity can control the overall false-positive risk across a defined set of tests, while an unadjusted result addresses only its individual comparison. Without a reported strategy, secondary p-values should not be treated as if they were adjusted or independently confirmatory.
The analysis population is defined for the primary outcome as the intention-to-treat population: all randomized subjects who received at least 1 dose of study medication. The record does not report the number analyzed for the primary endpoint, how missing seizure-frequency observations were handled, whether participants who discontinued treatment contributed later data, or whether sensitivity analyses were conducted. Those details matter because missing outcome data can affect both the estimated group summaries and the comparison between groups.
For the secondary outcomes, denominators vary by outcome and arm. The registry record does not explain the reasons for those varying analysis counts or report a general missing-data strategy. The endpoint-specific sample sizes should therefore be considered when interpreting their precision, and it is not possible from the registry record to determine whether missingness differed in ways that could bias a comparison.
The sponsor’s primary ANCOVA is reported with a confidence interval and p-value, but the record does not report the covariates, model diagnostics, analysis conventions, or sensitivity analyses. The trial’s sample-size justification and any interim analyses are not reported in the registry record. These omissions limit assessment of how closely the posted analysis follows a prespecified statistical plan.
12. 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 |
|---|---|---|---|
| Placebo | 6 | 100 | 6.0% |
| Brivaracetam 20 mg/Day | 2 | 99 | 2.0% |
| Brivaracetam 50 mg/Day | 4 | 99 | 4.0% |
| Brivaracetam 100 mg/Day | 2 | 100 | 2.0% |
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 |
|---|---|
| Placebo | 22 of 100 |
| Brivaracetam 20 mg/Day | 31 of 99 |
| Brivaracetam 50 mg/Day | 35 of 99 |
| Brivaracetam 100 mg/Day | 37 of 100 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo | Brivaracetam 20 mg/Day | Brivaracetam 50 mg/Day | Brivaracetam 100 mg/Day |
|---|---|---|---|---|---|
| Convulsion | Nervous system disorders | 3 of 100 | 0 of 99 | 1 of 99 | 0 of 100 |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | 0 of 100 | 1 of 99 | 0 of 99 | 0 of 100 |
| Amnesia | Psychiatric disorders | 0 of 100 | 0 of 99 | 1 of 99 | 0 of 100 |
| Angina pectoris | Cardiac disorders | 1 of 100 | 0 of 99 | 0 of 99 | 0 of 100 |
| Gastritis erosive | Gastrointestinal disorders | 0 of 100 | 0 of 99 | 1 of 99 | 0 of 100 |
| Grand mal convulsion | Nervous system disorders | 0 of 100 | 0 of 99 | 1 of 99 | 0 of 100 |
| Humerus fracture | Injury, poisoning and procedural complications | 0 of 100 | 0 of 99 | 0 of 99 | 1 of 100 |
| Jaw fracture | Injury, poisoning and procedural complications | 0 of 100 | 1 of 99 | 0 of 99 | 0 of 100 |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | 1 of 100 | 0 of 99 | 0 of 99 | 0 of 100 |
| Psychotic Disorder | Psychiatric disorders | 0 of 100 | 0 of 99 | 1 of 99 | 0 of 100 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | Brivaracetam 20 mg/Day | Brivaracetam 50 mg/Day | Brivaracetam 100 mg/Day |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | 10 of 100 | 14 of 99 | 18 of 99 | 9 of 100 |
| Somnolence | Nervous system disorders | 6 of 100 | 8 of 99 | 6 of 99 | 8 of 100 |
| Dizziness | Nervous system disorders | 5 of 100 | 5 of 99 | 7 of 99 | 5 of 100 |
| Fatigue | General disorders | 2 of 100 | 3 of 99 | 4 of 99 | 8 of 100 |
| Vertigo | Ear and labyrinth disorders | 3 of 100 | 1 of 99 | 2 of 99 | 8 of 100 |
| Nasopharyngitis | Infections and infestations | 1 of 100 | 8 of 99 | 1 of 99 | 2 of 100 |
| Nausea | Gastrointestinal disorders | 4 of 100 | 0 of 99 | 1 of 99 | 6 of 100 |
| Convulsion | Nervous system disorders | 1 of 100 | 5 of 99 | 1 of 99 | 2 of 100 |
| Irritability | Psychiatric disorders | 0 of 100 | 0 of 99 | 5 of 99 | 1 of 100 |
Serious events with the highest arm-level rate: convulsion (3.0%), abortion spontaneous (1.0%), amnesia (1.0%), gastritis erosive (1.0%), grand mal convulsion (1.0%).
The safety summaries report serious adverse events among participants at risk in each arm. The registry lists 6 affected participants among 100 at risk in the placebo group, 2 among 99 at risk with brivaracetam 20 mg/day, 4 among 99 at risk with brivaracetam 50 mg/day, and 2 among 100 at risk with brivaracetam 100 mg/day. These are counts of affected participants, not a comparison adjusted for exposure time or other factors. The registry record does not provide deaths for these arms; death information is not reported in the registry record.
Other adverse events are also listed as affected-participant counts: 22 among 100 in the placebo group, 31 among 99 with 20 mg/day, 35 among 99 with 50 mg/day, and 37 among 100 with 100 mg/day. The record lists serious adverse event terms including Convulsion at 3.0%, and Abortion spontaneous, Amnesia, Gastritis erosive, Grand mal convulsion, and Jaw fracture at 1.0% each. These term percentages should be read as registry listings; the record does not give further context about event timing, relatedness, or event-level overlap. Serious adverse event counts alone do not establish whether an event was caused by study treatment, and the registry record does not report a comparative safety analysis.
13. What the Result Does, and Does Not, Mean
The primary result provides descriptive seizure-frequency summaries for placebo and three brivaracetam doses, together with one sponsor-reported adjusted comparison of brivaracetam 50 mg/day with placebo. The sponsor’s estimate is 6.5 for percentage reduction over placebo, with a 95% confidence interval from -5.2 to 16.9 and p = 0.261. The interval includes zero and leaves substantial uncertainty about the magnitude and direction of the comparison.
This result does not establish that every dose has the same effect, because the registry record does not report sponsor comparisons for the other doses on the primary endpoint. Nor does it establish that the observed arm medians are themselves adjusted treatment effects. A median is a group summary; an ANCOVA estimate is a modeled contrast. The results should be interpreted according to the quantity each analysis measures.
The finding also does not show that no effect is possible. A confidence interval that includes zero can still be compatible with effects in either direction, and the interval’s width is relevant to how precisely the effect is estimated. Conversely, the numerical point estimate alone does not prove an effect. Statistical uncertainty and clinical importance are separate questions; the registry record does not provide a threshold for a clinically important difference.
Secondary endpoints provide additional descriptive information but do not replace the primary comparison. Their unadjusted nature and the absence of a reported multiplicity plan limit how strongly they can support confirmatory claims. The registry record also does not supply enough detail to evaluate the primary model, missing-data assumptions, or all aspects of the analysis plan. The posted results therefore support a bounded statistical interpretation rather than a broad conclusion about efficacy or safety.
14. Why This Trial Matters Statistically
This trial illustrates why an endpoint’s summary statistic and its treatment comparison must be kept distinct. The primary outcome is a median weekly seizure frequency with an inter-quartile range, while the sponsor’s inferential result is an ANCOVA estimate expressed as percentage reduction over placebo. Readers need to know both what was observed within arms and what contrast the analysis actually estimated.
It also illustrates the importance of reporting uncertainty, not only a point estimate or p-value. The sponsor’s confidence interval extends across zero and includes a range of possible estimates. This makes precision central to interpretation: the evidence is not summarized adequately by whether a single threshold is crossed.
The registry record includes multiple doses and numerous secondary outcomes, creating a setting where multiplicity matters. Unadjusted exploratory comparisons can be useful for generating hypotheses, but their evidential weight differs from a prespecified primary analysis with a documented multiplicity strategy. The record’s limited reporting of the analysis plan, missing-data handling, model details, and sample-size justification also shows how registry summaries can leave important questions unresolved.
Finally, the planning illustrations demonstrate a distinction between retrospective planning calculations and the design of the completed trial. Calculations based on an observed effect can help readers understand how sample requirements depend on the effect targeted, but they are not observed power and do not reveal the original design rationale. Keeping these interpretations separate helps prevent descriptive results, sponsor analyses, and planning examples from being conflated.
15. 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 primary endpoint is reported with arm-level medians and inter-quartile ranges, but the registry record does not provide the underlying participant-level data or a recalculated pairwise contrast from those summaries. The sponsor’s inferential comparison covers brivaracetam 50 mg/day versus placebo only. The absence of sponsor-reported primary comparisons for 20 mg/day and 100 mg/day limits assessment of dose-specific contrasts from the registry results.
Further detail about the primary ANCOVA is not reported, including its covariates, model specification, missing-data handling, and sensitivity analyses. The record also does not report the original sample-size justification, any interim analyses, or the complete statistical plan. These gaps restrict independent evaluation of the analysis choices and their robustness.
Secondary results cover different outcome types and have varying analysis counts. The registry record does not explain all differences in denominators or provide a common account of missingness across outcomes. The secondary comparisons described as recalculated are unadjusted, and no multiplicity strategy is reported. Their numerical estimates therefore have limits as confirmatory evidence.
The safety information consists of affected-participant counts and listed serious adverse event terms. The record does not provide a comparative safety model, event relatedness, exposure-adjusted analyses, or death counts. These omissions constrain interpretation of between-arm safety differences. More generally, registry summaries cannot answer questions that depend on details not reported in the registry record, including whether the analyses followed a prespecified plan in every respect.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures — NCT00490035.
- Registry record last updated 2022-07-21; status last verified 2022-07.
- Results first posted 2016-04-13.
- 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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19. Record Summary
NCT00490035 is a completed phase 3 randomized, parallel-group, placebo-controlled study sponsored by UCB Pharma SA. It enrolled 399 participants with partial onset seizures, with brivaracetam doses of 20 mg/day, 50 mg/day, and 100 mg/day compared with matching placebo. The primary endpoint was median Type I partial onset seizure frequency per week over the 12-week treatment period.
The posted primary arm summaries give medians and inter-quartile ranges. The sponsor reports an ANCOVA comparison of brivaracetam 50 mg/day with placebo: percentage reduction over placebo of 6.5, 95% confidence interval -5.2 to 16.9, and p = 0.261. Selected secondary outcomes have descriptive summaries and unadjusted recalculations, while a multiplicity strategy and several analysis details are not reported in the registry record. The posted results should be read with those limits in mind.