A Phase 2 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Patients With Multi-Site Pain Associated With Post-Acute Sequelae of SARS-CoV-2 Infection: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Phase 2 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Patients With Multi-Site Pain Associated With Post-Acute Sequelae of SARS-CoV-2 Infection (NCT05472090), a randomized phase 2 study. The primary outcome is Daily Diary Pain NRS.

2. Clinical Question

The clinical question centers on the difference between randomized groups, rather than whether either group changed from its own baseline. Both groups had negative mean changes in the posted results. A between-group estimate helps distinguish the observed changes under the study treatment assignments, while its confidence interval describes the uncertainty around that estimate. The registry record does not report a threshold for a clinically meaningful difference, so the size of the numerical contrast alone cannot establish its clinical importance.

The study also listed sleep quality, fatigue, and cognitive function as secondary outcomes. These measure different aspects of participants’ reported experience and provide additional context, but they do not replace the primary pain outcome. Their results should be read with attention to uncertainty and to the fact that secondary comparisons are unadjusted.

3. Trial Design

This was a Phase 2, randomized, parallel-group, placebo-controlled study with quadruple masking. The study title describes a 14-week treatment period and evaluation of efficacy and safety. The registry record lists an enrollment of 63 and a completed status. The listed primary outcome analysis included 32 participants assigned to TNX-102 SL and 31 assigned to placebo.

Participants in the active-treatment group took TNX-102 SL sublingually at bedtime, beginning with a 2.8 mg tablet daily for 2 weeks and then taking 5.6 mg daily for 12 weeks. The placebo group followed a corresponding tablet schedule. The registry describes the study as double-blind in its official title and lists quadruple masking in the design information. It does not identify which additional groups, beyond participants and study staff implied by the masking description, were included in that designation.

The primary outcome was assessed at Week 14. The registry defines the analysis population as randomized patients who had at least one post-baseline daily diary entry. The record gives the arm-level primary outcome estimates and identifies the outcome measure as a least-squares mean with standard error. It does not report the statistical model, covariates, or detailed handling of repeated diary observations.

Three secondary outcomes were posted: daily diary sleep quality, PROMIS fatigue, and PROMIS cognitive function. Each has Week 14 arm-level estimates. The registry record lists no reported analyses for these secondary endpoints. The study began on 2022-08-18, and the primary completion date is 2023-07-12. These design and record details describe the trial structure; they do not by themselves establish the magnitude or certainty of any treatment-group difference.

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.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Intention-to-treat (ITT) population defined as all patients who were randomized and had at least one post-baseline daily diary entry.

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.

6. Primary Endpoint

The registry lists the primary outcome as Daily Diary Pain NRS, measured over Week 14.

The primary endpoint was change from baseline at Week 14 in the weekly average of daily self-reported worst Long COVID pain intensity. Participants recorded pain using a Numeric Rating Scale from 0 to 10, where higher scores mean worse pain. The reported arm-level estimates are least-squares mean changes, accompanied by standard errors.

A daily diary asks participants to report symptoms close to the time they occur. Averaging daily reports into a weekly measure can represent the participant’s reported pain across that period, rather than relying on a single recollection at the endpoint. That is a general rationale for diary-based symptom measurement; the registry record does not state why this particular measure or endpoint timing was selected.

Change from baseline expresses how the measured score shifted over the study period. Because higher scores indicate worse pain, a negative change means the recorded score was lower than baseline on average. The randomized comparison, however, is the difference between the groups’ mean changes. The posted results show a mean change of -2.2 for TNX-102 SL and -2.0 for placebo, with a between-group estimate of -0.2. The comparison’s confidence interval spans zero, so the estimate is compatible with a range of possible group differences that includes no difference.

The endpoint captures reported pain intensity, not every feature of post-acute sequelae or multisite pain. The registry record does not report a clinically meaningful-change threshold for interpreting the scale, nor does it provide the specific statistical model used to produce the least-squares means.

7. Results Posted in the Registry

• TNX-102 SL Tablet, 5.6 mg: mean -2.20 versus -2.00 on control; difference -0.20 (95% CI -1.16 to 0.76), standardized effect d = -0.10; z-test p = 0.682.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Daily Diary Sleep Quality NRS

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
• Result:
  • TNX-102 SL Tablet, 5.6 mg: mean -2.10 versus -1.60 on control; difference -0.50 (95% CI -1.57 to 0.57), standardized effect d = -0.23; z-test p = 0.358.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between TNX-102 SL Tablet, 5.6 mg and the control. The interval gives the range of effects that remain compatible with the data.

PROMIS Fatigue -Short Form 8a

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
• Result:
  • TNX-102 SL Tablet, 5.6 mg: mean -8.00 versus -3.20 on control; difference -4.80 (95% CI -9.42 to -0.18), standardized effect d = -0.51; z-test p = 0.042.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for TNX-102 SL Tablet, 5.6 mg than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

PROMIS Cognitive Function - Abilities-Short Form 8a

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
• Result:
  • TNX-102 SL Tablet, 5.6 mg: mean 5.40 versus 3.50 on control; difference 1.90 (95% CI -2.40 to 6.20), standardized effect d = 0.22; z-test p = 0.386.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between TNX-102 SL Tablet, 5.6 mg and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes cover sleep quality, fatigue, and cognitive function at Week 14. Their arm-level changes and recalculated group contrasts do not form a uniform pattern of statistical evidence: the sleep and cognitive-function intervals include zero, while the fatigue interval does not. The registry record lists no reported analyses for these secondary outcomes; the comparisons are recalculated, unadjusted results based on the posted summaries.

These measures add context to the primary pain outcome because they address other reported aspects of participants’ experience. They do not directly measure the primary endpoint, and a difference on one does not establish a difference on another. Nor can secondary findings resolve the uncertainty in the primary pain comparison. The primary estimate remains -0.2, with a confidence interval crossing zero and an unadjusted p-value of 0.682.

The fatigue comparison’s unadjusted p-value is 0.042, but it should be interpreted cautiously. The study reports several outcomes, and the registry record does not describe a multiplicity adjustment or identify a hierarchy for testing secondary endpoints. In general, testing multiple outcomes increases the chance that at least one result appears notable by chance. An unadjusted secondary result therefore carries less confirmatory weight than a prespecified primary result supported by a documented analysis plan.

Interpretation also depends on scale meaning. The primary pain measure explicitly states that higher values mean worse pain, but the registry record does not state the direction of better or worse outcomes for each secondary scale. The secondary numerical changes should therefore be interpreted according to their measure definitions rather than assuming that a negative or positive change has a particular clinical meaning. The registry record also does not report thresholds for meaningful change on these secondary measures.

Taken together, the secondary data can inform future questions about sleep, fatigue, and cognitive function, but they do not provide a substitute primary endpoint or a multiplicity-adjusted confirmation. Their estimates should be considered alongside their confidence intervals, the small endpoint group sizes, and the absence of reported secondary analysis details.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Daily Diary Sleep Quality NRS
• PROMIS Fatigue -Short Form 8a
• PROMIS Cognitive Function - Abilities-Short Form 8a

9. Statistical Interpretation

10. Statistical Methods Explained

The registry reports each arm’s Week 14 primary outcome as a least-squares mean, with a standard error. A least-squares mean is a model-based group mean; in general, such means can account for factors specified in the model. The registry record does not identify the model or the factors used, so the role of any adjustment cannot be determined from the posted record. A standard error describes the estimated uncertainty in a mean, rather than the spread of individual participants’ scores.

What does the group difference represent?

The primary contrast is the mean change in the TNX-102 SL group minus the mean change in the placebo group. The posted arm estimates are -2.2 and -2.0, and the recalculated difference is -0.2. A negative contrast means the estimated change is more negative in the active-treatment arm; it does not by itself establish that the difference is reliable or important. The direction and size need to be read alongside the confidence interval and the outcome’s scale.

In general, a comparison between randomized groups is more informative about the effect of assignment than interpreting either group’s change alone. Participants in both groups can change over time for many reasons, including natural variation and factors shared by the trial groups. The placebo comparison helps provide context for those changes. This general principle does not establish that every possible source of bias was eliminated in this trial.

How should the p-value be read?

The primary comparison has an unadjusted p-value of 0.682. In general, a p-value describes how unusual data at least as discrepant as those observed would be under a specified null model. It is not the probability that the null hypothesis is true, nor is it a measure of the probability that the treatment is effective. The registry record does not report the primary test’s full model or assumptions, so the recalculated p-value should be read as an unadjusted summary-statistic comparison rather than as a substitute for an undocumented sponsor analysis.

The fatigue comparison’s unadjusted p-value is 0.042. An unadjusted value does not account for the fact that multiple outcomes are being examined. General statistical practice treats repeated testing as a reason for caution: when many comparisons are considered, some may appear notable by chance even if no multiplicity procedure is applied. The record does not report such a procedure for these endpoints.

What do the confidence intervals add?

A confidence interval gives a range of estimates compatible with the data and the method used to calculate it. In general, a wider interval means less precision. For a difference, an interval that crosses zero includes the possibility of no group difference under the calculation’s assumptions. It does not prove that the groups are equivalent; equivalence requires a defined margin and an appropriate analysis, neither of which is reported in the registry record.

The primary comparison interval includes zero. The sleep-quality and cognitive-function intervals also include zero, while the fatigue interval is entirely below zero. These recalculated intervals derive from the posted arm summaries and are unadjusted. They do not incorporate any multiplicity correction or undisclosed model adjustments. The secondary estimates and intervals should therefore be interpreted as exploratory evidence rather than as definitive tests.

What is recalculated?

The arm-level means and standard errors are posted registry results. The between-group differences, confidence intervals, unadjusted p-values, and standardized effect summaries are recalculated from those summaries; they are not presented in the record as reported analyses. The pooled standard deviation used for the standardized comparisons is approximate, inferred from arm-level standard errors. Such calculations can be useful for a transparent, rough comparison, but they cannot reproduce a participant-level analysis when the original model, covariance structure, missing-data methods, or covariate adjustments are not available.

For the primary endpoint, the standardized effect estimate is -0.103. This expresses the estimated contrast relative to an estimated pooled standard deviation, rather than in the original pain-scale units. Standardization can facilitate comparison across measures, but its interpretation depends on the variability estimate and does not supply a clinical-importance threshold.

The registry record defines the primary analysis population, but does not report the detailed statistical analysis plan, model specification, handling of missing diary entries, or whether any interim analyses occurred. The record also does not report the original sample-size justification. Those omissions limit the ability to assess alignment between the posted calculations and the trial’s intended analysis. General explanations of least-squares means, standard errors, p-values, and confidence intervals describe statistical concepts, not undisclosed procedures used in this trial.

11. Confidence Intervals and Precision

The primary estimated mean difference is -0.2 points on the pain scale. Its recalculated unadjusted confidence interval runs from -1.156 to a positive upper bound and crosses zero. The lower endpoint represents a contrast more favorable to a larger reduction in the TNX-102 SL group; the positive part of the interval allows for a contrast in the opposite direction. The interval therefore includes both no difference and a range of potentially different group contrasts. It is wide relative to the point estimate, making the estimate imprecise.

A confidence interval is not a guarantee that the true value lies within its limits. In general, it describes uncertainty under the calculation’s statistical assumptions. Here, the interval is based on posted summary statistics, and the registry record does not provide the full model needed to verify whether it matches the sponsor’s intended analysis. The interval should be understood as a recalculated, unadjusted estimate.

The arm-level standard errors are 0.34 for TNX-102 SL and 0.35 for placebo. Standard errors describe uncertainty around the arm means; they are not the range of individual pain scores. The primary sample sizes were 32 and 31, which helps explain why uncertainty remains despite the point estimate being close to zero. No conclusion about equivalence follows from a confidence interval that crosses zero. Equivalence would require an acceptable difference margin and a suitable analysis, neither reported in the registry record.

The secondary intervals vary in width and relation to zero. The sleep-quality interval spans zero, the fatigue interval lies below zero, and the cognitive-function interval spans zero. Because those are unadjusted secondary comparisons and the record does not report a multiplicity procedure, their interval coverage does not account for examining several outcomes. More precise interpretation would require the prespecified analysis details and a clinical interpretation framework for each measure.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning estimates give participants per arm, not total events. They use a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. For each illustration, the effect to detect is the stated fraction of the observed effect. The trial’s own original design assumptions and sample-size justification are not reported in the registry record.

For the primary endpoint, planning for 100% of the observed effect lists 1,471 participants per arm for 80% power and 1,969 participants per arm for 90% power. The 80% column describes the planned chance of detecting the specified effect under the stated assumptions if that effect were the true one; the 90% column applies a higher target probability under the same general setup. These are design-planning concepts, not probabilities that the result is true.

Planning for 75% or 50% of the observed effect produces larger participant requirements than planning for the full observed effect. Smaller effects are harder to distinguish from random variation, so they require more participants to reach the same target power under these assumptions. Estimates differ by endpoint because the observed effects and variability differ.

These figures are hypothetical planning illustrations based on the observed results, not the trial’s original design calculation. They are not observed power. Observed power is not a useful substitute for reading the effect estimate and its confidence interval: the interval directly communicates the range of effects compatible with the posted data. The displayed planning values also depend on the normal approximation and equal allocation assumptions and should not be treated as a reconstruction of the actual trial protocol.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -0.200; pooled standard deviation σ = 1.936.
2. n = 2 × (1.96 + 0.842)² × 1.936² / -0.200² = 1,470.7, rounded up to 1,471 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -0.2                      # observed difference in means
sigma <- 1.93585750051368                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(5472090)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 1,471 (80% power), 1,969 (90% power)
 75% of observed effect: n per arm = 2,615 (80% power), 3,501 (90% power)
 50% of observed effect: n per arm = 5,883 (80% power), 7,876 (90% power)
power.t.test: 1471.7 
Simulated power at n = 1,471 per arm: 0.796 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry record lists one primary outcome and three secondary outcomes. The primary outcome is daily diary pain at Week 14; secondary outcomes are daily diary sleep quality, PROMIS fatigue, and PROMIS cognitive function. The record does not report a multiplicity-control strategy, a testing hierarchy, or adjustments to the secondary p-values. The posted secondary comparisons are unadjusted recalculations.

Multiplicity matters because examining multiple outcomes creates multiple opportunities for an apparently notable result. In general, adjustment procedures can control the overall chance of false-positive conclusions across a family of tests, but they may also affect precision or power. Without a stated procedure, the fatigue p-value of 0.042 cannot be interpreted as though it were adjusted for the other outcomes. The registry record does not establish whether a multiplicity plan was specified elsewhere.

The record defines the primary intention-to-treat population as all randomized patients with at least one post-baseline daily diary entry. It does not explain how missing daily diary observations were handled, whether any participants were excluded after randomization, or how missing data affected the Week 14 least-squares means. The registry record does not report sensitivity analyses for missing data.

It also does not describe the primary statistical model, included covariates, repeated-measures structure, or assumptions about the distribution of outcomes. These details matter because different model choices and missing-data methods can affect estimates, standard errors, and confidence intervals. The posted registry summaries do not permit an independent reconstruction of a participant-level analysis.

The registry record does not report interim analyses or the trial’s original sample-size justification. It also lists no reported analyses for the secondary endpoints. These gaps do not demonstrate that such procedures were absent from the full study documentation; they mean that they are not reported in the registry record. In consequence, the recalculated comparisons support a descriptive reading of the posted summaries, but a fuller assessment of confirmatory inference requires a prespecified analysis plan and complete analysis details.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent non-serious adverse event terms

The posted safety figures list 32 participants at risk in the TNX-102 SL group and 31 in the placebo group. Serious adverse events affected 0 participants in each group, and deaths were 0 in each group. These figures describe the counts posted in the registry record; they do not establish that the risks are identical.

Other adverse events affected 12 participants assigned to TNX-102 SL and 2 assigned to placebo. The registry record does not give the event types in these summary figures, their severity, timing, or whether individual participants experienced more than one event. The counts should not be interpreted as rates of a particular event or as a complete account of tolerability.

Zero observed serious events in these groups does not rule out events that were not observed in a study of this size. The record’s serious-event term list is empty. These results are a descriptive summary of the trial’s posted safety data, not a basis for broad claims about safety beyond the study population and observation period.

16. What the Result Does, and Does Not, Mean

The primary result is an estimated between-group difference of -0.2 in change on the daily diary pain scale at Week 14. The confidence interval includes zero, and the unadjusted p-value is 0.682. These statistics indicate that the posted summaries do not establish a clear difference between TNX-102 SL and placebo on the primary outcome. They do not prove that the treatments are equivalent, or that no difference exists.

The arm-level mean changes were -2.2 for TNX-102 SL and -2.0 for placebo. Both are negative, which corresponds to lower scores than baseline on a scale where higher scores mean worse pain. But the interpretation of the trial question depends on the contrast between those changes, not on either group’s change in isolation. The contrast is estimated imprecisely, and the record does not state what size of difference would be clinically meaningful.

The secondary results include an unadjusted fatigue comparison whose interval does not include zero, alongside sleep-quality and cognitive-function intervals that do. Because several outcomes were examined and no multiplicity adjustment is reported, the secondary findings warrant caution. They do not overturn the primary result, and the record does not provide thresholds that would establish clinical importance for these measures.

The trial was randomized and placebo-controlled, but the registry summaries do not include the full statistical analysis details. In particular, the model, missing-data methods, and any adjustments are not reported. The comparisons described in the statistical interpretation are recalculated from posted summaries and should not be mistaken for the sponsor’s complete participant-level analysis.

The appropriate reading is therefore bounded: the registry record reports arm-level outcomes and permits unadjusted comparisons, but the primary estimate is uncertain and its interval includes no difference. The safety figures report no serious adverse events or deaths in either group and more participants with other adverse events in the TNX-102 SL group. These trial results do not by themselves support medical advice or conclusions beyond the recorded outcomes, groups, and study period.

17. Why This Trial Matters Statistically

This trial illustrates why a randomized comparison should be read through both its point estimate and its uncertainty. A negative change occurred in each arm, but the primary question is whether the groups differed. The estimated between-group difference is -0.2, and the confidence interval includes zero. Reporting only the arm-level changes could obscure the importance of the placebo comparison.

It also illustrates the limits of small-group estimates. The primary endpoint includes 32 participants in the TNX-102 SL arm and 31 in the placebo arm. With this amount of information, the confidence interval remains broad enough to include differences in either direction. The data therefore do not reduce uncertainty to a narrow range, even though they yield a single point estimate.

The posted secondary outcomes show why multiplicity and prespecification matter. A secondary fatigue comparison has an unadjusted p-value of 0.042, while the primary comparison’s unadjusted p-value is 0.682. Without a reported multiplicity strategy or secondary analysis plan, the isolated secondary result has limited confirmatory force. Statistical significance in one measure cannot be considered independently of the set of outcomes examined.

Finally, the record distinguishes posted arm summaries from a complete statistical analysis. Recalculated comparisons can make summary data more interpretable, but model choices, covariates, and missing-data methods are not available in the registry record. This case highlights the value of transparent reporting of analysis plans, uncertainty, and endpoint definitions when interpreting clinical trial results.

18. 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 comparison is based on a relatively small set of endpoint participants, with 32 in the TNX-102 SL group and 31 in the placebo group. The resulting confidence interval is wide enough to include no difference and contrasts in either direction. The study is Phase 2, and the registry enrollment is 63; these results should be interpreted in that context rather than treated as a precise estimate.

Several analysis details are not reported in the registry record. These include the primary model, any covariate adjustment, handling of missing diary entries, sensitivity analyses, and interim analyses. Although the primary population is defined, the record does not show how missing observations or departures from the intended diary schedule were handled. The original sample-size justification is also not reported.

The primary and secondary comparisons described in the statistical interpretation are recalculated, unadjusted comparisons from posted summary statistics. They are not reported sponsor analyses. The registry record does not report secondary analyses or a plan for controlling multiplicity. The approximate standard deviations used for standardized effect estimates are inferred from standard errors, adding uncertainty to those summaries.

The outcomes are self-reported measures, and the registry record does not provide a clinically meaningful difference threshold for the pain scale or the secondary measures. It also does not specify the direction of better or worse outcomes for the secondary scales. As a result, statistical contrasts cannot be translated into clinical importance from the record alone.

Finally, the results describe the enrolled study population and the listed Week 14 outcomes. The registry record does not establish how well they generalize beyond patients with multisite pain associated with post-acute sequelae of SARS-CoV-2 infection or beyond the study period. The posted adverse-event summary also lacks event types and additional detail needed for a fuller safety interpretation.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: A Phase 2 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Patients With Multi-Site Pain Associated With Post-Acute Sequelae of SARS-CoV-2 Infection — NCT05472090.
• Registry record last updated 2024-11-26; status last verified 2024-11.
• Results first posted 2024-11-26.
• 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.

22. Record Summary

NCT05472090 is a completed Phase 2, randomized, parallel-group, quadruple-masked, placebo-controlled study of TNX-102 SL for multisite pain associated with post-acute sequelae of SARS-CoV-2 infection. The registry lists enrollment of 63 and a 14-week treatment period, with dosing at bedtime.

The primary outcome was Week 14 change from baseline in the weekly average of daily worst-pain Numeric Rating Scale scores. The arm-level mean changes were -2.2 for TNX-102 SL and -2.0 for placebo. The recalculated unadjusted difference was -0.2, with a confidence interval spanning zero and an unadjusted p-value of 0.682.

Three secondary outcomes were posted. Their comparisons are unadjusted recalculations, and the registry record does not report secondary analyses or a multiplicity procedure. Serious adverse events and deaths were 0 in both groups; other adverse events affected 12 participants assigned to TNX-102 SL and 2 assigned to placebo.