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 Placebo-Controlled, Single-Dose Challenge Study of Gaboxadol in Adult Males With Fragile X Syndrome (FXS) (NCT06334419), a randomized phase 2 study. The primary outcome is Target Engagement of Gaboxadol Treatment on EEG Power.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06334419 |
| Phase | Phase 2 |
| Condition | Fragile X Syndrome |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | Quadruple |
| Enrollment | 10 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Craig Erickson |
| Results posted | Yes |
2. Clinical Question
Population
Adult males aged 18 to 40 years, inclusive, with a diagnosis of Fragile X syndrome were eligible. The registry record lists an enrollment of 10. The primary endpoint describes means that include two sessions per participant for each condition, one at home and one in the lab.
Intervention
The intervention was a single oral dose of gaboxadol, 10 mg, given at a study visit. Gaboxadol was administered once at home and once in the lab, with the order varying by assigned sequence.
Comparator
The comparator was matched placebo, also administered as a single oral dose at home and in the lab. Participants received both gaboxadol and placebo under the crossover design, rather than remaining in one treatment group throughout the study.
Primary question
The primary question was whether EEG absolute power changed from pre-dose to 60 minutes post-dose after gaboxadol, compared with the corresponding pre-dose and post-dose observations after placebo. The endpoint covers resting theta, alpha, and gamma power, with home and lab values averaged. The registry record does not report the numerical treatment comparison, its uncertainty, or a statistical test result.
3. Trial Design
This was a phase 2, randomized, quadruple-masked, placebo-controlled crossover study. The registry record lists enrollment of 10 and describes adult males aged 18 to 40 years, inclusive, with Fragile X syndrome. The study is marked completed. Its listed start date is 2024-01-29, and its primary completion date is 2025-05-13.
Each participant was scheduled for two in-home and two in-clinic visits, for four visits in all. Visits were described as 14 days apart. At each visit, participants took a single oral dose of gaboxadol or matched placebo, with dosing intended to be blinded. The intervention description states that participants received both treatments at home and in the lab. This structure allows within-participant comparisons, because each participant contributes observations under both conditions.
The registry record lists four treatment sequences. They vary the order in which gaboxadol and placebo are given at home and in the lab. The sequences therefore also vary whether a condition is encountered earlier or later in the visit schedule. Details on how the sequence assignment was generated, whether allocation was concealed, and how adherence to the schedule was assessed are not reported in the registry record.
The primary endpoint compares pre-dose with 60 minutes post-dose on study visits, with the timeframe described as extending up to day 42. The registry record also lists secondary aims concerning the feasibility of home visits and EEG recording, pharmacokinetics, neuropsychological and eye-tracking assessments, clinician-rated measures, and whether FMRP levels predict response. The exact statistical models used to evaluate these aims are not reported in the registry record.
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.
First intervention (1 day)
| Stage | Placebo in Lab, Gaboxadol in Home, Gaboxadol in Lab, Placebo in Home | Gaboxadol in Lab, Gaboxadol in Home, Placebo in Lab, Placebo in Home | Placebo in Lab, Placebo in Home, Gaboxadol in Lab, Gaboxadol in Home | Gaboxadol in Lab, Placebo in Home, Placebo in Lab, Gaboxadol in Home |
|---|---|---|---|---|
| STARTED | 2 | 3 | 3 | 2 |
| COMPLETED | 2 | 3 | 3 | 2 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Washout period (14 days)
| Stage | Placebo in Lab, Gaboxadol in Home, Gaboxadol in Lab, Placebo in Home | Gaboxadol in Lab, Gaboxadol in Home, Placebo in Lab, Placebo in Home | Placebo in Lab, Placebo in Home, Gaboxadol in Lab, Gaboxadol in Home | Gaboxadol in Lab, Placebo in Home, Placebo in Lab, Gaboxadol in Home |
|---|---|---|---|---|
| STARTED | 2 | 3 | 3 | 2 |
| COMPLETED | 2 | 3 | 3 | 2 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Second intervention (1 day)
| Stage | Placebo in Lab, Gaboxadol in Home, Gaboxadol in Lab, Placebo in Home | Gaboxadol in Lab, Gaboxadol in Home, Placebo in Lab, Placebo in Home | Placebo in Lab, Placebo in Home, Gaboxadol in Lab, Gaboxadol in Home | Gaboxadol in Lab, Placebo in Home, Placebo in Lab, Gaboxadol in Home |
|---|---|---|---|---|
| STARTED | 2 | 3 | 3 | 2 |
| COMPLETED | 2 | 3 | 3 | 2 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Washout period (14 days)
| Stage | Placebo in Lab, Gaboxadol in Home, Gaboxadol in Lab, Placebo in Home | Gaboxadol in Lab, Gaboxadol in Home, Placebo in Lab, Placebo in Home | Placebo in Lab, Placebo in Home, Gaboxadol in Lab, Gaboxadol in Home | Gaboxadol in Lab, Placebo in Home, Placebo in Lab, Gaboxadol in Home |
|---|---|---|---|---|
| STARTED | 2 | 3 | 3 | 2 |
| COMPLETED | 2 | 3 | 3 | 2 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Means include two sessions per participant for each condition (gaboxadol and placebo), with one collected in-home and the other collected in-lab.
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 | Placebo in Lab, Gaboxadol in Home, Gaboxadol in Lab, Placebo in Home | Gaboxadol in Lab, Gaboxadol in Home, Placebo in Lab, Placebo in Home | Placebo in Lab, Placebo in Home, Gaboxadol in Lab, Gaboxadol in Home | Gaboxadol in Lab, Placebo in Home, Placebo in Lab, Gaboxadol in Home | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 2 | 3 | 3 | 2 | 10 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 2 | 3 | 3 | 2 | 10 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 2 | 3 | 3 | 2 | 10 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 2 | 3 | 3 | 2 | 10 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 0 | 1 | 0 | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 1 | 3 | 2 | 2 | 8 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Target Engagement of Gaboxadol Treatment on EEG Power, measured over Pre-dose compared to 60 minutes post-dose on 4 study visits, up to day 42.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | μV²/Hz |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is target engagement assessed through EEG power. EEG records electrical activity at the scalp; the endpoint focuses on resting theta, alpha, and gamma frequency bands. For each band, absolute power is expressed in μV²/Hz. The registry description defines the measure as median power averaged across 129 electrodes. It then describes means that average home and lab values.
The central measurement is the change from pre-dose to 60 minutes after dosing. The treatment contrast of interest is whether that change differs between gaboxadol and placebo. The endpoint description includes two sessions per participant for each condition: one in-home session and one in-lab session. Averaging across the settings makes the endpoint reflect both environments rather than treating either setting as the sole measurement context.
EEG power is used as a physiological measure of target engagement: it provides an observable brain-signal outcome after dosing. It is not, by itself, a direct measure of everyday functioning or a clinical benefit. Interpreting it requires attention to the treatment comparison, variability across participants and sessions, and the precision of the estimate. Numerical means, treatment effects, standard deviations, confidence intervals, and test results for the primary endpoint are not reported in the registry record, so the magnitude and precision of any difference cannot be assessed from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes the primary EEG outcome and the study design, but it does not report the numerical primary results. There is no posted estimate of the gaboxadol-versus-placebo contrast, no confidence interval, and no p-value in the registry record for this analysis. The direction, magnitude, and statistical precision of the primary comparison therefore cannot be characterized. The record also does not report the band-specific means or standard deviations needed to describe the observed EEG values.
The primary outcome is not a single undifferentiated measurement. It includes resting theta, alpha, and gamma absolute power, measured before and after dosing, with observations from home and lab sessions averaged. A result for one frequency band would not automatically describe the other bands. Likewise, an average across settings would not establish that the response was the same at home and in the lab. The registry record does not give setting-specific estimates or a band-by-band account of the findings.
The crossover design means that participants contribute observations under both gaboxadol and placebo. This can make within-participant contrasts informative because stable differences between individuals can be separated from changes across conditions. However, the usefulness of that comparison depends on the order of treatment, the completeness and quality of each participant's measurements, and the analysis used to account for the repeated observations. The statistical model, treatment of sequence or period effects, and handling of incomplete data are not reported in the registry record.
The registry lists an enrollment of 10. The small study size makes it especially important to read an estimate together with its uncertainty rather than relying only on a threshold-based test. But neither an estimate nor an interval is reported for the primary endpoint, so its precision cannot be judged. Any planning illustration based on the observed effect should be understood as a design calculation, not as observed power or as evidence that a future study would reproduce the same result. The observed effect itself is not reported in the registry record.
Consequently, the posted information supports a description of the trial's question and measurement strategy, not a conclusion about the size or reliability of an EEG difference. The completion status does not substitute for results, and the listed aims do not indicate whether each analysis met its objective. A reader should distinguish the existence of a planned physiological comparison from evidence about the outcome of that comparison.
9. Statistical Methods Explained
What does a crossover comparison mean?
In a crossover study, participants receive more than one study condition at different times. Here, participants were scheduled to receive gaboxadol and placebo, with doses given in both home and lab settings. The main statistical advantage is that each participant can serve as their own reference. A comparison within the same person can reduce the influence of stable characteristics that differ across people.
That advantage does not remove every source of uncertainty. Measurements can vary from session to session, and the order of conditions can matter. A participant's response after one visit could potentially differ from a later response for reasons unrelated to treatment. For this reason, crossover analyses often account for the repeated observations and may consider period or sequence effects. The registry record lists four sequences but does not report the model used, whether order effects were evaluated, or how such effects were handled. No claim about those analytical choices can be made from the registry record.
What does a mean describe?
The primary endpoint is identified as a mean of a continuous measure. A mean describes the average measurement in the group or condition being summarized. In this study, the endpoint description says that means use the average of home and lab values and that the underlying power measure is median power averaged across 129 electrodes. These are different stages of summarizing the EEG: the electrode-level measure is described first, and the home and lab values are then averaged for the reported means.
A mean alone does not show how much participants or sessions differed from one another. The registry identifies standard deviation as the dispersion measure for the primary outcome, but the numerical means and standard deviations are not reported in the registry record. A standard deviation describes spread around a mean; it is not the uncertainty around the mean treatment contrast. That uncertainty is commonly described with a confidence interval, which gives a range of values compatible with the data under the analysis assumptions. A confidence interval for the primary comparison is not reported in the registry record.
Why does the treatment contrast matter?
The endpoint is a pre-dose to post-dose change, and the scientific comparison is the difference in that change between gaboxadol and placebo. Looking only at post-dose values could mix a treatment response with differences that were already present before dosing. Comparing changes focuses on how measurements shift after each condition. The registry describes the timing and the comparison but does not report the estimated contrast or the calculation used to obtain it.
Because the design is crossover, a suitable analysis would need to respect the fact that multiple observations come from the same participant. In general, observations from one person are not independent in the same way as measurements from unrelated people. Treating repeated measurements as independent can misstate uncertainty. This is a general statistical point, not a description of the model used in this trial; the model and its assumptions are not reported in the registry record.
How should p-values and intervals be read?
A p-value, when reported, assesses how compatible the observed data are with a specified null model, given the analysis assumptions. It does not measure the size or clinical importance of an effect, and it does not give the probability that a treatment hypothesis is true. A confidence interval adds information about the range of effect sizes compatible with the data and is useful for judging precision. Neither a primary p-value nor a confidence interval appears in the registry record, so neither statistical significance nor estimate precision can be evaluated.
Small studies can produce imprecise estimates, even when an estimated contrast appears sizeable. Conversely, a result that does not meet a chosen significance threshold does not establish that the conditions are equivalent. These general principles are particularly relevant when enrollment is 10 and when the endpoint includes several frequency bands. They do not establish what this study found; the numerical results are not reported in the registry record.
What do the planning illustrations represent?
The registry describes planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also says the effect to detect is expressed as a stated fraction of the observed effect. These are planning assumptions, not a report of the trial's original design justification. The record does not report the trial's own sample-size justification, and the observed effect and numerical planning results are not reported in the registry record.
Such illustrations estimate the participants per arm that might be needed under their assumptions. They are not observed power, and they do not show that the completed study had a particular probability of detecting an effect. In a crossover study, a simple two-arm illustration may not represent every feature of the actual design. General planning calculations also depend on assumptions about variability and the effect to detect. The record does not provide enough numerical outcome information to assess those assumptions independently.
Why are multiple outcomes relevant?
The primary endpoint includes theta, alpha, and gamma bands, and the registry lists nine outcome measures and five analyses. When several outcomes or analytical comparisons are considered, the chance of at least one apparently notable finding can increase if results are interpreted without regard to multiplicity. Adjustment methods or a prespecified hierarchy can address this issue, but the statistical plan and any multiplicity procedure are not reported in the registry record. The number of listed outcomes alone does not show which comparisons were confirmatory or how conclusions were drawn.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint includes multiple EEG frequency bands: theta, alpha, and gamma. The registry also lists nine outcome measures and five analyses, with secondary aims spanning home-visit feasibility, high-density EEG feasibility, pharmacokinetics, neuropsychological assessments, eye tracking, clinician-rated measures, and FMRP as a possible predictor of response. Considering multiple outcomes or analyses can raise the possibility of chance-positive findings. Whether the study used a hierarchy of outcomes, adjusted significance thresholds, or another multiplicity strategy is not reported in the registry record.
The registry does not report how missing EEG sessions or other incomplete measurements were handled. It is not clear from the record whether the primary analysis used all available observations, required complete paired observations, or used another approach. The analysis population, exclusions after enrollment, and reasons for missing data are not reported in the registry record. Without these details, readers cannot assess whether the analyzed observations represent all participants as intended or whether incomplete data could affect the comparison.
The record describes a crossover schedule and four treatment sequences, but it does not report the statistical model or whether the analysis accounted for repeated measurements, treatment sequence, visit period, or setting. It also does not report an interim-analysis plan or a prespecified statistical analysis plan. These omissions limit assessment of how the primary comparison was defined and how alternative outcomes were considered. They do not establish that a particular method was or was not used; they mean the method is not reported in the registry record.
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 |
|---|---|---|---|
| Gaboxadol in Home | 0 | 10 | 0.0% |
| Gaboxadol in Lab | 0 | 10 | 0.0% |
| Placebo in Home | 0 | 10 | 0.0% |
| Placebo in Lab | 0 | 10 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Gaboxadol in Home | 0 of 10 |
| Gaboxadol in Lab | 0 of 10 |
| Placebo in Home | 0 of 10 |
| Placebo in Lab | 0 of 10 |
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 |
|---|---|
| Gaboxadol in Home | 2 of 10 |
| Gaboxadol in Lab | 5 of 10 |
| Placebo in Home | 0 of 10 |
| Placebo in Lab | 3 of 10 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Gaboxadol in Home | Gaboxadol in Lab | Placebo in Home | Placebo in Lab |
|---|---|---|---|---|---|
| Fatigue | General disorders | 2 of 10 | 4 of 10 | 0 of 10 | 1 of 10 |
| Fever | General disorders | 0 of 10 | 1 of 10 | 0 of 10 | 0 of 10 |
| Elevated heart rate | Cardiac disorders | 0 of 10 | 0 of 10 | 0 of 10 | 1 of 10 |
| Emotional disturbance (anxiety, aggression, crying) | Psychiatric disorders | 0 of 10 | 0 of 10 | 0 of 10 | 1 of 10 |
The registry reports serious adverse events and other adverse events separately for each condition. For serious adverse events, the number affected is 0 in each listed group, with 10 at risk in each group. The recorded deaths are 0 in each group. No serious adverse event terms are listed among the top serious terms.
For other adverse events, the affected counts are 2 for gaboxadol at home, 5 for gaboxadol in the lab, 0 for placebo at home, and 3 for placebo in the lab. Each group lists 10 at risk. These are condition-specific counts in a crossover study, where participants may contribute observations under more than one condition. The figures should therefore be read by group and setting, not added together as if each entry necessarily represented a different participant.
Zero reported serious adverse events in these groups means none were recorded in the listed serious-event counts; it does not establish that a treatment is free of risk. The registry record does not provide event descriptions for the other adverse-event counts, their severity, timing, relatedness assessments, or details about how events were collected. The counts alone cannot establish whether differences between conditions are meaningful.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this was a randomized, quadruple-masked crossover study designed to compare single-dose gaboxadol with matched placebo in adult males with Fragile X syndrome. It identifies EEG absolute power as the primary target-engagement measure and describes the pre-dose to 60-minute post-dose comparison across home and lab sessions. It also reports condition-specific adverse-event counts and lists secondary study aims.
Those design details do not establish the size or direction of the primary treatment contrast. Numerical EEG results, uncertainty intervals, and primary statistical tests are not reported in the registry record. It is therefore not possible to say from the record whether gaboxadol was associated with higher or lower power in any band, how consistent the measurements were, or how precisely any contrast was estimated. The same limitation applies to the listed secondary aims: their descriptions do not demonstrate that an outcome changed or that a feasibility target was met.
Even if a numerical EEG contrast were available, target engagement would remain a physiological finding. An EEG power measure is not automatically equivalent to a change in symptoms, function, or quality of life. The registry record does not report a direct relationship between the primary EEG outcome and a clinical benefit, nor does it provide a basis for translating an EEG contrast into an individual-level prediction.
The adverse-event counts describe what was recorded in the listed groups, but sparse counts and limited event detail restrict interpretation. The absence of recorded serious events in the groups is not proof of no risk, and other adverse-event counts alone do not establish a causal treatment effect. Overall, the record describes an exploratory clinical-trial question and its measurements; without numerical outcome results and analysis details, conclusions about treatment effects or their precision are not supported.
13. Why This Trial Matters Statistically
This study raises statistical questions that are important in early clinical research. Its crossover design makes within-participant comparisons possible, while also requiring attention to repeated measurements, treatment order, and visit timing. The four listed sequences show that order was part of the study structure, but the analysis used to account for it is not reported in the registry record. That distinction matters: a well-described design is not enough to evaluate whether the analysis matched the design.
The endpoint also combines several dimensions of measurement. It includes three EEG frequency bands, pre-dose and post-dose observations, and home and lab settings. Averaging across settings can create a concise outcome, but it can also conceal setting-specific variation. The record describes an average across home and lab values without reporting the band-specific or setting-specific numerical estimates. This makes it impossible to assess whether a combined measure represents similar patterns across contexts.
The study is listed with enrollment of 10. In a study of this size, uncertainty and the influence of individual observations warrant particular attention. An estimate should be interpreted alongside its interval and the analysis assumptions, not as a standalone number. Here, the primary estimate and its uncertainty are not reported. The registry's mention of planning illustrations based on an observed effect should not be mistaken for evidence of observed power or for the trial's original sample-size rationale.
Finally, the record lists several outcome measures and analyses, making transparency about outcome hierarchy and multiplicity relevant. Reporting the planned analysis, missing-data handling, and results for the primary endpoint would allow readers to distinguish the principal comparison from exploratory findings. These statistical features are central to judging what a small crossover study can establish, independently of whether any particular result appears promising.
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 main limitation for interpreting this trial from the registry record is that the numerical primary EEG findings are not reported. The record identifies the outcome, its units, the frequency bands, and the measurement timing, but it does not give the condition means, treatment contrast, standard deviations, confidence intervals, or test results. As a result, neither the direction nor the precision of the primary comparison can be evaluated.
The endpoint pools information from home and lab sessions, yet setting-specific estimates are not reported. The primary outcome spans theta, alpha, and gamma power, but band-specific results are also not reported. A single averaged description cannot show whether the measurements behaved similarly across bands or environments.
The registry describes a crossover schedule and treatment sequences but does not report the statistical model, the handling of sequence or period effects, or the analysis population. Missing-data methods, exclusions, adherence information, and reasons for incomplete measurements are not reported in the registry record. Multiplicity procedures for the several outcomes and analyses are also not reported.
The enrollment is 10, and the registry provides only limited safety detail: condition-specific counts, without descriptions of other adverse events, severity, timing, or relatedness. The record does not report a rationale for the trial's sample size or enough outcome values to evaluate the planning illustrations. These limitations concern what can be concluded from the registry record; they do not establish that the unreported analyses or details were absent from other study documents.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Placebo-Controlled, Single-Dose Challenge Study of Gaboxadol in Adult Males With Fragile X Syndrome (FXS) — NCT06334419.
- Registry record last updated 2026-09-30; status last verified 2026-07.
- Results first posted 2026-09-30.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a completed phase 2, randomized, quadruple-masked, placebo-controlled crossover study in adult males aged 18 to 40 years, inclusive, with Fragile X syndrome. Enrollment is listed as 10. Participants were scheduled for four home and lab visits, receiving single oral doses of gaboxadol, 10 mg, and matched placebo across the visit sequence.
The primary outcome is EEG absolute power in resting theta, alpha, and gamma bands, comparing pre-dose with 60 minutes post-dose and averaging home and lab values. Secondary aims cover feasibility, pharmacokinetics, neuropsychological and eye-tracking assessments, clinician-rated measures, and FMRP as a possible predictor of response.
The registry reports no serious adverse events or deaths in the listed groups and gives condition-specific counts for other adverse events. Numerical primary EEG results, statistical uncertainty, the analysis model, missing-data methods, and multiplicity procedures are not reported in the registry record. The design and outcome are therefore identifiable, but the magnitude and precision of the primary result cannot be summarized.