Post-stroke Neural Plasticity With Atomoxetine: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Post-stroke Neural Plasticity With Atomoxetine (NCT02788357), a randomized phase 2 study. The primary outcome is Change in Fugl Meyer Assessment.

2. Clinical Question

This is a pilot study, and its enrollment was 12. The registry describes a randomized, parallel-group design with quadruple masking. The posted information therefore identifies the intended treatment contrast and outcome, but does not establish what the observed treatment effect was. The trial question is about the added effect associated with atomoxetine in the setting of a shared motor-training program; the registry record does not provide the outcome estimates needed to quantify that contrast.

3. Trial Design

The registry identifies NCT02788357 as a Phase 2, randomized, quadruple-masked, parallel-group study. Enrollment was 12, and the record marks the study as completed. Its title is Post-stroke Neural Plasticity With Atomoxetine, and the official title describes it as a pilot study of enhancement of post-stroke neural plasticity with atomoxetine.

The two arms paired study medication with task-oriented therapy. The Atomoxetine arm received 40 mg atomoxetine for 10 consecutive weekdays alongside therapy; the comparison arm received placebo capsules with the same therapy schedule. This shared training schedule is important to interpretation: a contrast between arms concerns the medication assignment in the context of motor training, not the isolated effect of training itself.

The registry reports a start date of 2006-11 and a primary completion date of 2012-12. The named sponsor is Lumy Sawaki. The record does not describe the random-sequence generation method, allocation concealment, the masking roles, or whether masking was assessed. It also does not report site details or a fuller description of eligibility criteria. Those design details should not be inferred from the labels “randomized” and “quadruple.”

In addition to the primary Fugl Meyer Assessment outcome, the registry lists change in Action Arm Research Test (ARAT), change in Wolf Motor Function Test (WMFT), and Transcranial Magnetic Stimulation as secondary outcomes. It records 4 outcome measures overall, but the numerical outcome estimates and analysis details are not reported in the registry record. The design description establishes how the intended comparison was organized; it does not, by itself, convey the results or establish how completely participants were followed.

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: 3 subjects in Atomoxetine group were lost to follow-up.

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 Change in Fugl Meyer Assessment, measured over baseline, post-intervention, 1-month follow-up.

The primary endpoint is change in the Fugl Meyer Assessment, expressed in units on a scale. The registry describes the measure as a score with possible values ranging from 0 to 66, with 66 indicating the best performance. It defines change as the score after intervention minus the baseline score and the score at 1-month follow-up minus the baseline score.

Change scores put follow-up measurements in relation to participants’ starting scores. This can make the outcome relevant to a question about improvement over the study period, while the between-group contrast asks whether the pattern of change differs between the atomoxetine-plus-training and placebo-plus-training arms. These are distinct ideas: a within-group change alone would not establish a difference between randomized groups.

General statistical context: a continuous outcome is often summarized by a group mean, while a confidence interval communicates uncertainty around an estimate. The registry identifies the mean and a 95% confidence interval as the planned form of reporting for this endpoint. It does not report numerical means, confidence limits, or a between-group estimate, so the observed size and precision of change are not reported in the registry record.

The endpoint is relevant to motor performance after stroke, but the record does not establish that it captures every aspect of hand function or neural plasticity. ARAT, WMFT, and Transcranial Magnetic Stimulation are separately listed secondary outcomes.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes the primary outcome as a mean on a continuous scale and names a 95% confidence interval as its dispersion measure. It does not report the actual mean, confidence limits, or a numerical between-group estimate. The registry also does not provide the statistical test or model used for the primary comparison, so a specific analysis method cannot be attributed to this study from the record.

What does a mean describe?

General statistical context: a mean represents the arithmetic average of observations in a group. For a change outcome, the mean change describes the average difference between the measured score at follow-up and the baseline score, using the definition specified for the endpoint. A group mean does not show how individual participants’ changes were distributed. Participants can have different individual outcomes while contributing to the same average.

When the scientific question concerns a treatment contrast, the key quantity is generally the difference in outcome between randomized groups at a defined time or the difference in their changes from baseline. A change within one arm answers a different question from a comparison across arms. The registry record does not give a numerical between-arm change estimate, and the primary outcome is not reduced to one comparison because it has several time points.

What does a confidence interval convey?

General statistical context: a confidence interval is an interval estimate that expresses uncertainty around an estimated quantity under the assumptions of the analysis. It is not a range containing every participant’s result, and it does not describe the spread of individual scores. Its width depends on factors such as the amount of information available and variation in the outcome. The registry specifies a 95% confidence interval, but without its limits there is no basis for describing the precision of the endpoint estimate.

General statistical context: confidence intervals are best read together with the estimate they accompany and the question being tested. Their interpretation depends on the estimand, analysis population, and method used. Those analysis details are not reported in the registry record. It is therefore not possible to determine from this record whether the interval would be adjusted for baseline values, whether it would be based on change scores, or what assumptions would govern its calculation.

Why do repeated time points matter?

General statistical context: measuring an outcome at multiple times can describe how a response evolves, but it also creates multiple possible contrasts. A result at post-intervention need not be the same as a result at follow-up. Selecting a time point after seeing the results can give a different impression from following a prespecified analysis plan. The registry signals multiple time points and states that the primary outcome is not reduced to one comparison. The plan for handling those time points is not reported in the registry record.

General statistical context: multiplicity refers to the increased chance of misleading findings when many outcomes, time points, or comparisons are examined. Methods such as prespecifying a primary contrast or adjusting inference can address this concern, but the registry record does not report whether such steps were planned or used. It would be incorrect to assume an adjustment, or to assume none, based on the brief endpoint description alone.

What is over-dispersion?

General statistical context: over-dispersion occurs when observed variability is greater than a statistical model expects. It is especially relevant for outcomes modeled as counts or rates, where an overly restrictive variance assumption can make uncertainty look smaller than it is. The primary outcome in this trial is described as a continuous mean, not a count. The registry does not report an over-dispersion assessment or a model for the primary endpoint, so this concept does not establish anything about the trial’s actual analysis.

The registry includes sample-size assumptions for a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect. Such an illustration is a planning calculation, not observed evidence and not the trial’s own design justification. The numerical planning results and the trial’s sample-size justification are not reported in the registry record. The illustration should not be interpreted as observed power or as proof that the study was adequately sized.

Overall, the statistical information available identifies the endpoint’s scale, summary form, and time points, but leaves the estimation and inferential methods unspecified. No p-value or calculated effect should be inferred. A useful interpretation would require the actual results and an account of the analysis population, missing-data approach, and handling of multiple time points; those details are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome is assessed at post-intervention and 1-month follow-up, each as a change from baseline. The registry explicitly notes that the primary outcome has several categories or time points and is not reduced to one comparison. It also lists secondary outcomes: change in ARAT, change in WMFT, and Transcranial Magnetic Stimulation. Examining multiple outcomes and time points creates multiple opportunities to observe apparently notable patterns, so the intended hierarchy and interpretation plan matter.

General statistical context: multiplicity can be handled in several ways, including identifying a primary contrast in advance, controlling error across a family of tests, or treating additional analyses as exploratory. The registry record does not report which approach, if any, was used. It does not report a detailed statistical analysis plan or adjustments for multiple comparisons. Therefore, the listed outcomes should not be treated as a set of independently confirmed findings.

The registry reports that 3 subjects in the Atomoxetine group were lost to follow-up. It does not report why they were lost, which endpoint measurements were unavailable, whether any participants in the placebo arm had missing measurements, or how missing data were handled. No imputation method, sensitivity analysis, or complete-case strategy is reported in the registry record. These omissions limit assessment of whether the available measurements represent all randomized participants.

The analysis populations are also not described. The record does not say whether analyses followed randomized assignment, included only participants who completed treatment, or used another population definition. It reports 0 analyses, and no numerical primary-outcome analysis is reported. As a result, the reported enrollment cannot be assumed to equal the number contributing to each endpoint analysis, and the effect of follow-up loss on the estimates cannot be assessed.

11. Safety Results

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

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry reports 6 participants at risk in each arm for serious adverse events and records 0 serious adverse events in both the Atomoxetine With Motor Training and Placebo With Motor Training groups. It also reports 6 participants at risk in each arm for other adverse events and records 0 other adverse events in both groups.

These figures describe what is recorded for the listed event categories. They do not establish that no event of any kind occurred, because the registry separates serious events from other adverse events and the posted results may not capture every possible safety detail. The record gives no top serious adverse-event terms. The deaths field is null for both groups, so a death count is not reported in the registry record; null should not be read as a reported count of zero.

General statistical context: a zero event count in a small study does not establish that the underlying risk is zero. When few participants are observed, uncommon events may not appear, and the data can provide limited precision about event rates. These safety figures should therefore be read as the registry’s recorded counts among the stated at-risk groups, not as a definitive estimate of safety in a broader population.

The registry does not provide further information about event definitions, surveillance procedures, or the period over which adverse events were collected. The counts alone cannot answer questions about the nature, timing, severity, or relationship of events to study treatment beyond the categories and values recorded.

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

The record establishes that this was a randomized, quadruple-masked, parallel-group pilot study comparing atomoxetine plus task-oriented therapy with placebo plus the same therapy. It identifies the Fugl Meyer Assessment as the primary endpoint, describes changes from baseline at post-intervention and 1-month follow-up, and lists several secondary outcomes. It also records enrollment of 12 and follow-up loss of 3 subjects in the Atomoxetine group.

Those details describe the design and intended measurements, not the observed effect. The numerical primary-outcome results are not reported in the registry record. There is therefore no basis in the posted information to state how much scores changed, whether the groups differed, or how precise any contrast was. The same limitation applies to the listed secondary outcomes: their numerical findings are not reported in the registry record.

General statistical context: a trial’s result is not determined by its design label or by the fact that an endpoint was measured. Interpretation depends on the observed estimates, their uncertainty, the analysis population, and the methods used. A pilot study can inform feasibility or help characterize outcomes, but the registry record does not report a specific feasibility result or a numerical efficacy estimate for this study.

The record also does not establish the reason for the observed follow-up loss, the handling of missing measurements, or the approach to multiple outcomes and time points. Those unknowns matter when deciding how representative the analyzed results might be and how much confidence to place in a particular contrast. Here, no numerical contrast is available to assess.

Accordingly, the posted information supports a description of what was planned and some recorded safety counts, but not a conclusion about the magnitude or direction of the primary outcome. It does not show that atomoxetine does or does not improve hand function after stroke, and it should not be used to make treatment decisions.

13. Why This Trial Matters Statistically

This study is statistically notable as a small pilot trial with a randomized comparison and a continuous functional outcome measured at more than one time point. Its design helps define the intended contrast: atomoxetine paired with motor training compared with placebo paired with the same training. Separating the medication contrast from the shared training program is important when interpreting what the comparison is intended to address.

The registry’s primary endpoint description makes clear that change from baseline is considered at post-intervention and at 1-month follow-up. Those repeated measurements can be informative about timing, but they also make a single, clearly specified primary contrast important for interpretation. The record states that the outcome is not reduced to one comparison, and it does not report how multiplicity was addressed. This illustrates why outcome definitions and analysis plans are needed alongside a trial’s design description.

The study also demonstrates why precision matters in pilot research. Enrollment was 12, and 3 subjects in the Atomoxetine group were lost to follow-up. Even without estimating a treatment effect, these registry entries draw attention to the availability of outcome data and the need to understand how missingness was handled. The numerical confidence interval and analysis population are not reported in the registry record, so the precision and robustness of any estimate cannot be evaluated.

General statistical context: a pilot study can be useful for refining outcome measurement and planning later research, but its role depends on its objectives and actual findings. The record does not state a sample-size justification or report numerical results from which to assess an effect. The planning illustration described in the registry is not a substitute for a stated design rationale or an observed analysis.

The value of this record is therefore primarily descriptive: it documents a trial question, a randomized structure, an endpoint schedule, and recorded event counts. It also highlights the difference between an endpoint being specified and its results being available for statistical interpretation.

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 most direct limitation for interpreting the study is that numerical primary-outcome results are not reported in the registry record. The record gives the endpoint definition and the intended summary form, but not the mean changes, confidence limits, or between-group estimate. Numerical findings for the listed secondary outcomes are also not reported in the registry record.

Enrollment was 12, and the record notes that 3 subjects in the Atomoxetine group were lost to follow-up. The reasons for loss, timing of loss, missing measurements, and handling of missing data are not reported. The analysis population is also not described, so it is not possible to determine how many participants contributed to each endpoint or whether analyses followed randomized assignment.

The primary endpoint spans post-intervention and 1-month follow-up, and the registry says it is not reduced to one comparison. The record does not report a prespecified contrast, multiplicity procedure, statistical model, or analysis plan. This makes it impossible to assess the inferential approach or determine how the repeated time points and additional outcomes were intended to be interpreted.

The record describes the study as randomized and quadruple-masked, but does not give the sequence-generation method, allocation concealment procedures, or the roles covered by masking. It does not report further participant characteristics or detailed eligibility criteria, limiting assessment of how well the enrolled group represents other post-stroke populations. These details are not reported in the registry record.

The safety counts record no serious or other adverse events in either at-risk group, but the deaths fields are null and additional surveillance details are absent. With the limited enrollment, the counts cannot characterize uncommon events precisely. Finally, the sample-size justification and numerical results of the planning illustration are not reported in the registry record. These limitations preclude judging the precision, generalizability, and robustness of an outcome estimate from the posted information.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Post-stroke Neural Plasticity With Atomoxetine — NCT02788357.
• Registry record last updated 2017-08-14; status last verified 2017-07.
• Results first posted 2017-08-14.
• 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.

18. Record Summary

NCT02788357 is a completed Phase 2 randomized, quadruple-masked, parallel-group pilot study titled Post-stroke Neural Plasticity With Atomoxetine. Enrollment was 12. The active arm paired 40 mg atomoxetine with task-oriented therapy for 10 consecutive weekdays; the comparison arm paired placebo capsules with the same therapy schedule.

The primary outcome was change in the Fugl Meyer Assessment, defined relative to baseline at post-intervention and 1-month follow-up. The registry lists ARAT change, WMFT change, and Transcranial Magnetic Stimulation as secondary outcomes. It records 3 subjects in the Atomoxetine group as lost to follow-up and 0 serious and 0 other adverse events among 6 participants at risk in each arm. Death counts are not reported in the registry record.

The registry does not report numerical primary-outcome results, secondary-outcome estimates, or statistical analyses. It also does not describe missing-data handling, analysis populations, or the approach to multiple time points and outcomes. The available record supports a description of the study design and endpoint definitions, but not a quantitative assessment of treatment effects.