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 Noise-Induced Hearing Loss-Acute Exposure Treatment (NCT04768569), a randomized phase 2 study. The primary outcome is The Ratio of PTS-positive Subjects.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04768569 |
| Phase | Phase 2 |
| Condition | Hearing Loss, Noise-Induced |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 24 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Washington University School of Medicine |
| Results posted | Yes |
2. Clinical Question
Population
Adults with noise-induced hearing loss following acute exposure were the intended population. The primary endpoint specifies the ITT Sample Set, but the registry record does not report further eligibility details or the number included in that analysis.
Intervention
One regimen gave zonisamide 100 mg PO pre-op and placebo post-op. Another gave placebo pre-op and zonisamide 100 mg PO post-op. The registry record describes the capsules as matching in appearance, smell, and taste.
Comparator
The all-placebo regimen used placebo pre-op and post-op. The registry record describes a randomized, double-blind, parallel-group design. It does not report the efficacy results for comparisons between these regimens.
Primary question
The primary endpoint is the ratio of PTS-positive participants within each study arm or group, assessed over 30 days. PTS-positive status means an increase in hearing threshold of ≥10 dB HL at any frequency from 2-6 kHz post-surgery compared with the baseline audiogram.
The study’s stated purpose was to assess the safety and efficacy of zonisamide for noise-induced hearing loss in adults. Its regimens distinguish whether zonisamide was taken pre-op or post-op, with placebo used at the other time point; the comparator uses placebo at both time points. Thus, the registry record describes questions about treatment timing as well as a comparison with placebo. It does not report an efficacy estimate for any of these comparisons, nor does it state whether the primary endpoint was analyzed separately by treatment timing.
The clinical question is therefore identifiable from the planned endpoint and arm descriptions, but its answer cannot be determined from the results recorded. The primary endpoint concerns a threshold change, not a general measure of hearing or a patient-reported outcome. The registry record also lists the rate of Distortion Product Otoacoustic Emissions (DPOAE) shift as a secondary outcome. How that secondary measure was defined or analyzed is not reported in the registry record.
3. Trial Design
The registry record identifies this as a phase 2, randomized, double-blind, parallel-group study. Enrollment is listed as 24. Washington University School of Medicine is the sponsor. The recorded study start is 2021-10-04, and primary completion is listed as 2023-09-29. The study status is terminated. The registry record does not explain the reason for termination or state whether termination occurred before or after planned enrollment or follow-up was complete.
The arm descriptions specify three treatment sequences: zonisamide pre-op followed by placebo post-op; placebo at both time points; and placebo pre-op followed by zonisamide post-op. The active capsule is described as zonisamide 100 mg PO. Capsules are described as having the same appearance, smell, and taste to support masking. The record does not provide further details about allocation procedures, concealment, who was masked, treatment duration, or the meaning and timing of the pre-op and post-op labels beyond the arm descriptions.
A parallel-group design assigns participants to a regimen that is compared with regimens assigned to other participants, rather than having every participant receive each regimen in sequence. Randomization is intended, in general, to reduce systematic differences between assigned groups. Double masking is intended, in general, to limit expectations from influencing care or outcome assessment. These are general design principles; the registry record does not describe how randomization or masking was implemented or maintained.
The primary outcome timeframe is 30 days. Its description refers to threshold measurement post-surgery and comparison with a baseline audiogram. The registry record does not report the precise schedule of audiograms, the surgery context, adherence, protocol deviations, or how outcome assessments were handled if a participant missed a visit. Those details should not be inferred from the arm labels alone.
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: 24 participants were consented for the study and enrolled. However, after consent but before any study activities could occur (including randomization), one participant chose to no longer participate. This excluded participant did not complete any study activities after consent. Thus, only 23 participants were consented and completed study activities including randomization.
Overall Study
| Stage | Zonisamide Pre-op + Placebo Post-op | Placebo Pre-op + Placebo Post-op | Placebo Pre-op + Zonisamide Post-op |
|---|---|---|---|
| STARTED | 8 | 7 | 8 |
| COMPLETED | 8 | 7 | 8 |
| NOT COMPLETED | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: ITT Sample Set
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.
| Characteristic | Unit | Zonisamide Pre-op + Placebo Post-op | Placebo Pre-op + Placebo Post-op | Placebo Pre-op + Zonisamide Post-op | Total |
|---|---|---|---|---|---|
| Participants analysed | 8 | 7 | 8 | 23 | |
| Age, Continuous | years | 49.4 (SD 15.2) | 49.7 (SD 12.37) | 53.6 (SD 9.75) | 51.0 (SD 12.23) |
| Sex: Female, Male: Female | Participants | 7 | 4 | 6 | 17 |
| Sex: Female, Male: Male | Participants | 1 | 3 | 2 | 6 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 8 | 7 | 8 | 23 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 0 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 7 | 7 | 8 | 22 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 8 | 7 | 8 | 23 |
6. Primary Endpoint
The registry lists the primary outcome as The Ratio of PTS-positive Subjects, measured over 30 days.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the ratio of PTS-positive participants to the total number of participants within each study arm or group. PTS-positive status is defined as an increase in hearing threshold of ≥10 dB HL at any frequency from 2-6 kHz post-surgery compared with the baseline audiogram. The stated timeframe is 30 days, and the population is the ITT Sample Set.
In general, a binary endpoint classifies each participant into one of two states for the specified outcome: meeting the definition or not meeting it. A proportion or ratio can then describe how often the defined event occurred within a group. This endpoint uses a threshold-change rule to make that classification. The phrase “at any frequency” means the definition is met if the qualifying threshold increase occurs at one or more frequencies in the stated range; the registry record does not report how measurements across frequencies were otherwise summarized.
In general, a threshold-based endpoint can provide a consistent rule for identifying a specified degree of change from baseline. It does not by itself describe the size of changes beyond the threshold, changes at frequencies outside the stated range, or how participants experience hearing. Those are different questions. The registry record does not provide a primary endpoint count, proportion, between-group estimate, or uncertainty interval, so the frequency of PTS-positive status and the precision of any comparison are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record specifies the primary endpoint and its clinical measurement rule, but does not provide an efficacy result for it. The analysis count recorded is zero, and the primary outcome is noted as having several categories or time points that were not reduced to one comparison. Consequently, there is no single primary comparison available to interpret from the posted results. No arm-specific primary endpoint counts, ratios, effect estimate, confidence interval, or p-value are reported in the registry record.
This absence does not establish that the groups had the same outcomes, nor does it establish that one regimen had a better outcome. It means the registry record does not provide the result needed to evaluate the primary endpoint. No conclusion about the direction or magnitude of an efficacy difference can be drawn from the endpoint definition, enrollment, or trial design alone.
In general, an effect estimate describes the observed difference or relationship between groups, while a confidence interval describes the statistical uncertainty around that estimate under the analysis assumptions. A p-value, when reported, addresses compatibility between the observed data and a specified null hypothesis; it is not a measure of clinical importance. None of these inferential quantities is reported for the primary endpoint in the registry record. The absence of these quantities also means that precision cannot be assessed.
The registry record does include adverse-event counts by group, but these are safety summaries and do not substitute for the primary hearing-threshold analysis. They should be read as counts of participants affected within the listed groups, not as evidence about the primary endpoint. No relationship between an adverse event and treatment is established by those counts alone.
The study is marked terminated. That status is relevant context, but the reason for termination, whether the planned analysis was completed, and whether termination affected follow-up are not reported in the registry record. It would be inappropriate to infer a reason or to treat termination itself as an efficacy result. The posted record supports description of the design, endpoint definition, and reported safety counts; it does not support a comparative efficacy conclusion.
9. Statistical Methods Explained
What does a binary endpoint represent?
General statistical explanation: a binary endpoint assigns each participant to one of two categories according to a prespecified rule. For this trial, the rule identifies PTS-positive status using an increase in hearing threshold of ≥10 dB HL at any frequency from 2-6 kHz post-surgery compared with baseline. The resulting group summary is described as the ratio of PTS-positive participants to the total number in that group. Such a ratio summarizes how frequently the defined event occurred in the analyzed group; it does not show the range of measurements among participants or how far a threshold changed once the rule was met.
The registry record names the ITT Sample Set as the primary outcome population. In general, an intention-to-treat approach analyzes participants according to their randomized assignment, regardless of whether they followed the assigned regimen, subject to the analysis rules. The precise ITT definition, handling of missing measurements, and number included in the primary analysis are not reported in the registry record. Therefore, the population label alone does not establish how incomplete outcome data or protocol deviations were handled.
How should a group comparison be read?
General statistical explanation: a comparison of binary outcomes can be expressed using different effect measures, including a difference between group proportions or a ratio of proportions. Each measure answers a somewhat different question. A difference describes the gap in event frequency on an absolute scale; a ratio describes the relative frequency. The choice of measure and its interpretation should follow the analysis plan and be read alongside uncertainty intervals. The registry record does not report which comparative measure was used for the primary endpoint or any estimated value.
Randomization supports a comparison of assigned groups by reducing the risk that treatment assignment is systematically related to participant characteristics, on average. It does not guarantee that groups will be identical, particularly in a small study. In general, baseline characteristics and outcome completeness help readers assess how the randomized groups compare in the observed data. Those details and the primary efficacy data are not reported in the registry record. The listed enrollment should not be treated as the number analyzed for the primary outcome.
What does masking contribute?
General statistical explanation: masking can reduce the influence of knowledge about treatment assignment on participants, trial staff, or outcome assessment. The record labels the study double-blind and describes capsules that look, smell, and taste the same. It does not identify which roles were masked or report whether masking was assessed or maintained. The design label and matching-capsule description provide context, but do not demonstrate that masking was successful throughout the trial.
Why does the endpoint definition matter?
General statistical explanation: a prespecified threshold converts continuous measurements into a yes-or-no outcome. This can make a definition operational and comparable across participants, but it also discards information about the magnitude of each measurement change. A participant just meeting the threshold and one with a larger increase are both classified as PTS-positive under the stated rule. Conversely, changes that do not meet the rule are not counted as positive for this endpoint. The registry record does not report continuous threshold-change results, frequency-specific findings, or additional rules for handling measurements.
The endpoint refers to any frequency from 2-6 kHz. In general, testing a condition across multiple frequencies can raise questions about how those measurements are combined and whether additional analyses are considered exploratory or confirmatory. The registry record provides the endpoint’s “any frequency” definition but does not report a more detailed analysis procedure for the frequency-level data. No additional method should be assumed.
What does the record allow readers to assess?
The primary analysis is not reported in the registry record, and the record notes that the outcome has several categories or time points that were not reduced to one comparison. Thus, statistical interpretation is limited to describing the endpoint and the design. There is no reported estimate with which to assess effect direction, magnitude, or precision, and no reported inferential test with which to assess statistical evidence under a specified model.
General statistical explanation: confidence intervals are useful because a point estimate alone does not show how much uncertainty is associated with the estimate. Wider intervals generally indicate less precision, while narrower intervals indicate greater precision under the model and sampling assumptions. An interval should not be interpreted as proof that every value within it is equally plausible or that values outside it are impossible. No confidence interval is reported for the primary endpoint, so precision cannot be characterized.
The record includes a planning illustration framework based on a stated fraction of an observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. These are described as planning assumptions, not as the trial’s own design justification. No resulting planning counts or observed primary effect are reported in the registry record. A planning illustration is not observed power and cannot replace a completed analysis. The trial’s sample-size justification and any statistical analysis plan are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record identifies a primary outcome and a secondary outcome, the rate of DPOAE shift. It does not report a multiplicity strategy, such as whether or how the analysis accounted for testing more than one outcome, comparison, frequency, or time point. The record also notes that the primary outcome has several categories or time points and was not reduced to one comparison. The intended hierarchy among possible comparisons, if any, is not reported in the registry record.
General statistical explanation: when multiple hypotheses are tested, the chance of obtaining at least one apparently unusual result can increase if each test is treated as independent evidence using the same decision threshold. A prespecified approach can clarify which outcomes are confirmatory and how results should be interpreted. No such approach should be assumed. Without the analysis plan and reported results, readers cannot determine how multiplicity was handled or whether a reported comparison, if any, would have been prespecified.
The primary outcome population is identified as the ITT Sample Set, but the registry record does not describe missing-data rules, imputation, exclusions from analysis, or sensitivity analyses. In general, missing outcome measurements can affect the estimate if participants with missing data differ in relevant ways from those with observed data. The amount and pattern of missing primary outcome data are not reported in the registry record, so the potential effect of missingness cannot be assessed.
The record does not report a detailed analysis population for the secondary outcome or explain how participants with incomplete follow-up were handled. Nor does it report an analysis plan, interim analyses, or sample-size justification. These omissions limit assessment of whether the reported outcome definitions, analysis choices, and handling of incomplete data followed a prespecified plan. They do not establish that any particular method was or was not used.
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 |
|---|---|---|---|
| Zonisamide Pre-op + Placebo Post-op | 2 | 8 | 25.0% |
| Placebo Pre-op + Placebo Post-op | 1 | 7 | 14.3% |
| Placebo Pre-op + Zonisamide Post-op | 1 | 8 | 12.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Zonisamide Pre-op + Placebo Post-op | 0 of 8 |
| Placebo Pre-op + Placebo Post-op | 0 of 7 |
| Placebo Pre-op + Zonisamide Post-op | 0 of 8 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Zonisamide Pre-op + Placebo Post-op | 8 of 8 |
| Placebo Pre-op + Placebo Post-op | 7 of 7 |
| Placebo Pre-op + Zonisamide Post-op | 8 of 8 |
Most frequent serious adverse event terms
| Event term | Organ system | Zonisamide Pre-op + Placebo Post-op | Placebo Pre-op + Placebo Post-op | Placebo Pre-op + Zonisamide Post-op |
|---|---|---|---|---|
| Brain Oedema | Nervous system disorders | 1 of 8 | 0 of 7 | 1 of 8 |
| Toxicity to Various Agents | Injury, poisoning and procedural complications | 1 of 8 | 0 of 7 | 0 of 8 |
| Ischaemic stroke | Nervous system disorders | 1 of 8 | 0 of 7 | 0 of 8 |
| Aphasia | Nervous system disorders | 1 of 8 | 0 of 7 | 0 of 8 |
| Encephalopathy | Nervous system disorders | 0 of 8 | 0 of 7 | 1 of 8 |
| Dysphagia | Gastrointestinal disorders | 0 of 8 | 1 of 7 | 0 of 8 |
| Cerebrial Infarction | Nervous system disorders | 0 of 8 | 1 of 7 | 0 of 8 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Zonisamide Pre-op + Placebo Post-op | Placebo Pre-op + Placebo Post-op | Placebo Pre-op + Zonisamide Post-op |
|---|---|---|---|---|
| Headache | Nervous system disorders | 5 of 8 | 5 of 7 | 7 of 8 |
| Nausea | Gastrointestinal disorders | 3 of 8 | 1 of 7 | 5 of 8 |
| Vertigo | Ear and labyrinth disorders | 3 of 8 | 1 of 7 | 4 of 8 |
| Procedural Pain | Injury, poisoning and procedural complications | 1 of 8 | 2 of 7 | 1 of 8 |
| Leukocytosis | Blood and lymphatic system disorders | 1 of 8 | 1 of 7 | 1 of 8 |
| Hyperglycaemia | Metabolism and nutrition disorders | 2 of 8 | 0 of 7 | 1 of 8 |
| Facial paresis | Nervous system disorders | 1 of 8 | 1 of 7 | 1 of 8 |
| Urinary Tract Infection | Infections and infestations | 1 of 8 | 0 of 7 | 1 of 8 |
| Deep vein thrombosis | Vascular disorders | 1 of 8 | 0 of 7 | 1 of 8 |
| Blood loss anaemia | Blood and lymphatic system disorders | 0 of 8 | 1 of 7 | 1 of 8 |
Serious events with the highest arm-level rate: dysphagia (14.3%), cerebrial infarction (14.3%), toxicity to various agents (12.5%), brain oedema (12.5%), ischaemic stroke (12.5%).
The registry record reports serious adverse events by treatment group. For zonisamide pre-op plus placebo post-op, 2 participants were affected among 8 at risk. For placebo pre-op plus placebo post-op, 1 participant was affected among 7 at risk. For placebo pre-op plus zonisamide post-op, 1 participant was affected among 8 at risk. The deaths count is 0 in each listed group. These are descriptive counts; they are not an adjusted comparison or an estimate of treatment-related risk.
The record also lists other adverse events: 8 affected among 8 at risk in the zonisamide pre-op plus placebo post-op group; 7 among 7 in the all-placebo group; and 8 among 8 in the placebo pre-op plus zonisamide post-op group. The registry record does not provide event-level descriptions for these other events in the information recorded here, so these counts should not be taken to mean that every participant experienced the same event or severity.
Several serious-event terms are listed with percentages: Dysphagia, 14.3%; Cerebrial Infarction, 14.3%; Toxicity to Various Agents, 12.5%; Brain Oedema, 12.5%; Ischaemic stroke, 12.5%; and Aphasia, 12.5%. The record does not state the denominator or attribution details for these term-level percentages. The terms and percentages should therefore be read as registry listings, not as evidence that an event was caused by a treatment or that groups differed reliably. Serious-event counts do not establish causation, comparative safety, or the primary efficacy result.
12. What the Result Does, and Does Not, Mean
The posted record establishes that this was a randomized, double-blind, parallel-group phase 2 study of zonisamide and placebo regimens for acute noise-induced hearing loss. It specifies a primary endpoint based on the proportion of participants meeting a threshold-change definition, and it describes the treatment timing in the assigned regimens. It also reports group-level adverse-event counts and a terminated study status.
It does not report a primary efficacy estimate or a statistical comparison of the regimens. Accordingly, the record cannot show whether the proportion of PTS-positive participants differed between groups, how large any difference was, or how precise an estimate might be. It also cannot establish that outcomes were equal. A missing result is not evidence of no effect; it is an absence of the result needed to assess the endpoint.
The primary definition is specific: a threshold increase of ≥10 dB HL at any frequency from 2-6 kHz post-surgery compared with baseline. This rule does not, by itself, report the continuous change in hearing threshold, the distribution of changes across frequencies, or the effect on other aspects of hearing. The secondary outcome name indicates a DPOAE shift rate, but its results are not reported in the registry record.
Safety counts describe participants affected as recorded for each group. They do not establish whether an event was caused by treatment, and the term-level percentages lack reported denominator and attribution details in the record. The termination status supplies context but does not explain why the trial ended or what happened to planned analyses and follow-up.
In general, interpreting a clinical trial requires both the estimated outcome and its uncertainty, together with information about analysis populations, missing data, and prespecified methods. Those details are not reported for the primary efficacy analysis. The available record therefore supports a careful account of trial design and outcome definitions, but not a conclusion about comparative efficacy or a definitive comparative safety assessment.
13. Why This Trial Matters Statistically
This trial is statistically notable because its primary endpoint turns hearing-threshold measurements into a binary participant-level outcome. The definition uses a change threshold and applies it if the qualifying increase occurs at any frequency from 2-6 kHz. That construction makes the endpoint explicit, while also highlighting a general trade-off: binary classification is straightforward to summarize, but it can conceal how large or small individual changes were and how measurements varied across frequencies.
The treatment regimens also distinguish timing. Zonisamide is assigned pre-op in one regimen and post-op in another, while the all-placebo regimen provides a comparison without active zonisamide. This design makes the assigned sequence relevant to the clinical question, but the registry record does not report efficacy estimates that would clarify the outcomes for the different sequences. The arm structure alone cannot answer whether timing matters.
The listed primary population is the ITT Sample Set, which makes the analysis population an important issue. In general, the interpretation of an intention-to-treat estimate depends on how randomized participants with missing outcomes or deviations are handled. The registry record does not describe those rules or report the primary analysis population size. That limits the ability to connect the planned population label to the actual outcome analysis.
Finally, the record’s terminated status and absence of a reported primary analysis make completeness and transparency especially relevant reading questions. The reason for termination and the status of follow-up are not reported. Without a primary estimate, uncertainty interval, and analysis details, readers cannot assess effect magnitude, precision, or the role of missing data. This is a useful reminder that a clearly stated endpoint and randomized design are necessary elements of a trial record, but they are not a substitute for reported outcome analyses.
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 principal limitation for interpreting this specific trial is that the primary efficacy analysis is not reported in the registry record. The endpoint definition is available, but there are no arm-specific PTS-positive counts, group ratios, comparative estimates, confidence intervals, or p-values. The record also notes that the primary outcome includes several categories or time points and was not reduced to one comparison, preventing interpretation of a single primary contrast.
The registry record lists enrollment as 24 but does not report the number analyzed for the primary outcome or the group-specific primary endpoint denominators. It does not describe missing-data handling, participant exclusions, protocol deviations, adherence, or sensitivity analyses. The ITT Sample Set is named, but operational details of that analysis population are not reported in the registry record.
The design information is also limited. Although randomization and double masking are recorded, the procedure for assignment, concealment, masked roles, and maintenance of masking are not described. The reason for termination is not reported, and the record does not explain whether termination affected recruitment, outcome collection, or analysis. The trial’s statistical analysis plan, sample-size justification, and interim-analysis approach are not reported in the registry record.
Safety interpretation is constrained by the descriptive nature of the counts. The record does not provide the term-level denominators or attribution details for the listed serious adverse event percentages. Counts alone cannot establish causation or support a reliable comparative safety conclusion. These limitations mean that the registry record can describe the planned clinical question and the recorded safety summaries, but it cannot establish the primary efficacy result or resolve the main uncertainties about analysis and follow-up.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Noise-Induced Hearing Loss-Acute Exposure Treatment — NCT04768569.
- Registry record last updated 2025-01-15; status last verified 2024-12.
- Results first posted 2025-01-15.
- 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.
Continue through the Clinical Biostats statistical pathway
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18. Record Summary
NCT04768569 is a terminated phase 2 randomized, double-blind, parallel-group study sponsored by Washington University School of Medicine. The recorded enrollment is 24; the study start is 2021-10-04, and primary completion is 2023-09-29. The regimens assign zonisamide 100 mg PO either pre-op or post-op, with placebo at the other time point, or placebo at both time points.
The primary endpoint is the ratio of PTS-positive participants within each group over 30 days. PTS-positive status is defined by an increase in threshold of ≥10 dB HL at any frequency from 2-6 kHz post-surgery compared with baseline audiogram. DPOAE shift rate is listed as a secondary outcome. The primary efficacy analysis and its statistical results are not reported in the registry record. Serious and other adverse-event counts are recorded by group, but they do not establish treatment causation or comparative efficacy. The reason for termination and details of missing-data handling are not reported.