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 Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) (NCT04507204), a randomized phase 4 study. The primary outcome is Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04507204 |
| Phase | Phase 4 |
| Condition | Attention-Deficit/Hyperactivity Disorder |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 267 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Purdue Pharma LP |
| Results posted | Yes |
2. Clinical Question
Population
The trial concerned adult and adolescent patients with attention-deficit/hyperactivity disorder in the United States. The stated primary outcome population was narrower: the Full Analysis Set adult population, consisting of randomly assigned patients who took at least one dose of study treatment. The record does not report the adult population's baseline characteristics or the number included in the primary outcome analysis.
Intervention
Adhansia XR capsules were taken orally once daily, with or without food. The study aimed to assess its real-world effectiveness, including symptom change by month 2 after treatment initiation and effectiveness over time.
Comparator
The active comparator was Concerta, taken orally once daily in the morning and swallowed whole with liquids, with or without food. The registry describes randomized allocation and a parallel-group design, but does not report the allocation procedure or group-specific results for the primary endpoint.
Primary question
The primary outcome was change in ADHD-RS-5 total score from baseline to month 2 among adults treated with Adhansia XR. It therefore addresses symptom change within the Adhansia XR group, rather than directly comparing change between Adhansia XR and Concerta. A separate secondary outcome was intended to assess the difference in Time Sensitive ADHD Symptom Scale scores between treatment groups for non-inferiority. The registry record does not report results for either question.
3. Trial Design
RE-DAX was a Phase 4, randomized, open-label, parallel-group study of Adhansia XR and Concerta. The official title describes it as a pragmatic study of real-world effectiveness in adult and adolescent patients with ADHD in the United States. Randomization means the study assigned participants to treatment groups; open-label means masking was not used. The registry record does not describe how randomization was implemented, whether allocation was concealed, or how treatment decisions were handled after assignment.
The registry reports enrollment of 267 and lists the study status as terminated. The recorded study start was 2020-07-30, and the primary completion date was 2021-12-22. The reason for termination and its timing in relation to recruitment or follow-up are not reported in the registry record. The record also does not explain whether termination affected the planned analyses or the availability of outcome data.
The primary outcome was the change in ADHD-RS-5 total score from baseline to month 2 among adults treated with Adhansia XR. Although the trial included an active comparator, this primary outcome is not phrased as a between-group comparison. The secondary outcomes included a between-group TASS assessment for non-inferiority, clinical global severity and improvement, treatment satisfaction, healthcare resource use, quality of life, work productivity and activity impairment, and sleep quality. The registry record does not report analysis results for these outcomes.
The intervention descriptions specify oral once-daily dosing for both treatments, with different instructions about timing and administration. The record does not report adherence, treatment changes, concomitant care, or the extent to which participants followed these instructions. It also does not report a statistical analysis plan or a sample-size justification. These omissions limit interpretation of how the trial was intended to estimate effectiveness and how closely the recorded design was 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
| Stage | Adhansia XR | Concerta |
|---|---|---|
| STARTED | 133 | 134 |
| COMPLETED | 83 | 86 |
| NOT COMPLETED | 50 | 48 |
Reasons for not completing this period:
| Reason | Adhansia XR | Concerta |
|---|---|---|
| Adverse Event | 8 | 13 |
| Death | 0 | 1 |
| Lost to Follow-up | 15 | 14 |
| Poor Compliance with Protocol | 2 | 4 |
| Other (e.g., PI judgment, moved out of state. etc.) | 4 | 3 |
| Withdrawal of Patient Consent | 21 | 13 |
Analysis population for the primary outcome, as defined in the registry: Full Analysis Set (FAS) Adult Population consisted of patients who were randomly assigned to study treatment and who took at least 1 dose of study treatment.
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 | Adhansia XR | Concerta | Total |
|---|---|---|---|---|
| Participants analysed | 133 | 134 | 267 | |
| Age, Continuous | years | 36.9 (SD 11.7) | 38.6 (SD 12.5) | 37.7 (SD 12.1) |
| Sex: Female, Male: Female | Participants | 71 | 73 | 144 |
| Sex: Female, Male: Male | Participants | 62 | 61 | 123 |
| Race/Ethnicity, Customized: Black or African American | Participants | 15 | 11 | 26 |
| Race/Ethnicity, Customized: White | Participants | 108 | 116 | 224 |
| Race/Ethnicity, Customized: Other | Participants | 10 | 7 | 17 |
| Race/Ethnicity, Customized: Hispanic or Latino | Participants | 23 | 21 | 44 |
| Race/Ethnicity, Customized: Not Hispanic or Latino | Participants | 108 | 113 | 221 |
| Race/Ethnicity, Customized: Not Reported | Participants | 2 | 0 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR, measured over Baseline to Month-2.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was change in the ADHD-RS-5 total score from baseline to month 2 among adults treated with Adhansia XR. The scale assesses the frequency and severity of each of the 18 ADHD symptoms based on DSM-5 criteria. Each symptom is rated on a 4 point scale from 0 (never or rarely) to 3 (very often), producing a total score from 0 to 54. Higher scores correspond to worse ADHD severity.
A change score is intended to describe how the measured symptom burden differs between the starting assessment and the later assessment. It can be useful because it focuses on within-person movement over a defined interval, rather than only describing scores at one visit. The meaning of an average change depends on the starting scores, variability among participants, and how many participants have usable measurements at both assessments. Those outcome summaries are not reported in the registry record.
The stated endpoint concerns adults receiving Adhansia XR; it does not itself estimate a difference between Adhansia XR and Concerta. A within-group change cannot separate treatment effects from other influences over time, including natural fluctuation, expectations, or changes in care. The study listed a separate secondary TASS outcome for comparison between treatment groups. The registry record does not report results for that comparison, or a threshold defining a clinically meaningful change on the primary scale.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary outcome and the population in which it was to be assessed, but does not report the primary outcome's numerical result. There is no posted mean change, standard deviation, confidence interval, p-value, or count of participants contributing to that outcome in the record described. Consequently, the magnitude and precision of the month-2 change cannot be evaluated from the registry information.
The distinction between the primary question and the comparative question matters. The primary endpoint concerns change among adults treated with Adhansia XR. Even if that change were reported, a before-and-after result in one treatment group would not on its own establish how that change compares with Concerta. The trial's secondary outcomes include a TASS comparison intended to assess non-inferiority, but the record does not report the estimate, its uncertainty, or a non-inferiority margin. The comparative result therefore cannot be interpreted from this record.
Enrollment of 267 describes the trial's recorded enrollment, not the number analyzed for the primary endpoint. The primary population definition requires random assignment and at least one dose of treatment, but the record does not report how many participants met that definition or how many had both baseline and month-2 scores. Nor does it describe missing endpoint data or the method used to handle them. The enrollment figure should not be treated as an analysis denominator.
The registry status is terminated, and the record gives a primary completion date but does not state why the trial was terminated or whether all planned follow-up was completed. Termination alone does not show whether an estimate is biased or whether the planned analysis was conducted; those details are not reported in the registry record. The absence of posted results also means that the statistical uncertainty and robustness of any endpoint estimate cannot be assessed.
Several safety counts are recorded by treatment group, including counts of participants affected by serious and other adverse events. These are descriptive counts, and no comparative safety analysis is reported. They should not be interpreted as establishing a difference between groups, particularly without information on event definitions, follow-up duration, exposure, or statistical uncertainty. Overall, the record supports a description of the study's design and intended questions, but not a conclusion about the size, precision, or comparative meaning of its primary clinical outcome.
9. Statistical Methods Explained
The registry identifies the primary outcome as a continuous measure summarized by a mean, with standard deviation as its dispersion measure. A mean describes the average score or average change in a group. A standard deviation describes how spread out individual values are around that average. It is not the uncertainty in the mean: uncertainty in an estimated mean is usually expressed with a confidence interval or another inferential measure. The registry record does not report the primary endpoint's mean, standard deviation, confidence interval, or p-value.
What does a change score describe?
A change score compares a participant's later measurement with their baseline measurement. A group mean change summarizes those individual changes. This approach directly describes movement over the stated interval, but interpretation still depends on the distribution of scores, the number of paired assessments, and whether participants with missing follow-up differ from those with observed follow-up. The registry defines the endpoint interval as baseline to month 2, but does not report the observed change or the handling of incomplete measurements.
The ADHD-RS-5 is bounded by the scale definition in the record: the 18 symptoms are each rated from 0 to 3 and the total ranges from 0 to 54, with higher scores indicating worse severity. Because a scale has a defined range, its observed distribution may not be well described by an average alone, particularly if scores cluster near a boundary or vary substantially among participants. The registry record does not report the distribution of baseline or follow-up values, so those features cannot be assessed.
What does randomization contribute?
In general, random assignment aims to make treatment groups comparable with respect to factors that could affect outcomes, including factors that are not measured. That benefit depends on how assignment is implemented and on what happens after assignment. The record describes the study as randomized and parallel-group, but does not report the randomization sequence, allocation concealment, or the analysis strategy for departures from assigned treatment. It is therefore possible to describe the stated design, but not to verify these implementation details.
The primary endpoint is specified for adults treated with Adhansia XR and is not a direct comparison with Concerta. A between-group treatment effect would ordinarily be expressed using a contrast between groups, with uncertainty around that contrast. The record lists a separate secondary TASS outcome for a between-group non-inferiority assessment. Non-inferiority interpretation generally depends on a prespecified margin, the estimated treatment contrast, and its confidence interval, as well as appropriate analysis populations and assumptions. The margin and the relevant results are not reported in the registry record.
How should uncertainty be understood?
In general, a confidence interval gives a range of values compatible with the observed data under the analysis assumptions. Its width reflects precision: wider intervals indicate less precise estimates, while narrower intervals indicate greater precision. A point estimate without an interval can conceal substantial uncertainty. Since the registry record does not report an estimate or confidence interval for the primary endpoint, neither the direction and size of the average change nor its precision can be assessed.
A p-value, when reported, describes how compatible data are with a specified null hypothesis under the model and assumptions used. It does not measure the probability that a treatment is effective, nor does it convey the clinical importance of an estimate. No primary endpoint p-value is reported in the registry record. Statistical significance cannot be inferred from the study design or enrollment alone.
Dispersion and the structure of the data matter to analysis. General statistical practice considers whether repeated observations within participants are correlated and whether the chosen model adequately represents the outcome distribution. Over-dispersion is a concern when a count model's observed variability exceeds what the model assumes; it can lead to uncertainty being understated if not addressed. The primary endpoint is described as continuous, and the registry record does not report a model, diagnostic checks, or an over-dispersion assessment. These are general considerations, not claims about analyses conducted in this trial.
What can planning calculations establish?
Sample-size calculations are planning illustrations, not observed trial outcomes and not observed power. The stated illustration assumptions use a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. The record does not provide the resulting planning values in the information available for interpretation, nor does it report that these assumptions formed the trial's original design. A sample-size justification and the trial's own statistical plan are not reported in the registry record. Planning calculations cannot recover an unreported treatment estimate or show what the trial's result would have been under another design.
10. Multiplicity, Missing Data and Analysis Populations
The record lists multiple secondary outcomes alongside the primary endpoint. When several outcomes or comparisons are tested, the chance of at least one apparently unusual result can increase unless the analysis plan addresses multiplicity. General approaches include defining a hierarchy of tests, adjusting significance thresholds, or interpreting a family of results with appropriate caution. The registry record does not report a multiplicity strategy, a testing hierarchy, or results for the listed secondary outcomes. It is therefore not possible to determine how any multiple testing was handled.
The registry reports zero analyses in the outcome information described, and the primary numerical result is not reported in the registry record. The absence of a posted analysis should not be taken as evidence that no analysis was conducted; it means the record does not provide the analysis results needed for interpretation. A statistical analysis plan, including model specifications and decisions about analysis populations, is not reported in the registry record.
The defined primary population is the Full Analysis Set adult population: patients randomly assigned to treatment who took at least one dose. The record does not give the number meeting this definition, the number with observed baseline and month-2 measurements, or the number included in each analysis. It does not state whether analyses used all available observations, required complete paired observations, or used an imputation or model-based method for missing data. The reasons and patterns of missingness are also not reported in the registry record.
Missing data can affect interpretation if the probability of having an observed outcome is related to participants' health, treatment, or unobserved outcome values. General statistical methods make assumptions about this process, and sensitivity analyses can examine how conclusions change under different assumptions. The record does not report such methods or checks. In addition, it does not report how participants who discontinued treatment or changed treatment were handled in the endpoint analysis. These omissions prevent assessment of whether the analysis population and missing-data approach match the clinical question.
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 |
|---|---|---|---|
| Adhansia XR | 3 | 133 | 2.3% |
| Concerta | 4 | 134 | 3.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Adhansia XR | 0 of 133 |
| Concerta | 1 of 134 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Adhansia XR | 28 of 133 |
| Concerta | 27 of 134 |
Most frequent serious adverse event terms
| Event term | Organ system | Adhansia XR | Concerta |
|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | 3 of 133 | 3 of 134 |
| Delusion | Psychiatric disorders | 1 of 133 | 0 of 134 |
| Hallucination, auditory | Psychiatric disorders | 1 of 133 | 0 of 134 |
| Death | General disorders | 0 of 133 | 1 of 134 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Adhansia XR | Concerta |
|---|---|---|---|
| Decreased appetite | Metabolism and nutrition disorders | 10 of 133 | 10 of 134 |
| Insomnia | Psychiatric disorders | 13 of 133 | 5 of 134 |
| Anxiety | Psychiatric disorders | 5 of 133 | 11 of 134 |
| Dry Mouth | Gastrointestinal disorders | 6 of 133 | 7 of 134 |
| Headache | Nervous system disorders | 4 of 133 | 7 of 134 |
Serious events with the highest arm-level rate: suicidal ideation (2.3%), delusion (0.8%), hallucination, auditory (0.8%), death (0.7%).
The registry reports safety counts separately for Adhansia XR and Concerta. For serious adverse events, the listed numbers at risk are 133 for Adhansia XR and 134 for Concerta; the numbers affected are 3 and 4, respectively. For other adverse events, the listed numbers at risk are 133 and 134, and the numbers affected are 28 and 27. The death counts are 0 and 1, respectively. These are registry-recorded counts, not calculated rates or adjusted comparisons.
The record also lists serious adverse event terms with percentages: Suicidal ideation, 2.3%; Delusion, 0.8%; Hallucination, auditory, 0.8%; and Death, 0.7%. The listing does not provide enough detail to establish how these terms map to treatment groups or whether the percentages use the same denominators as the group counts. They should not be combined with group counts or interpreted as comparative risks.
Counts alone do not show whether an apparent difference is statistically distinguishable from random variation. Interpretation would also require event definitions, observation time, treatment exposure, event timing, and an analysis accounting for these features; these details are not reported in the registry record. The listed figures describe recorded adverse events and do not establish that treatment caused an event or that a difference exists between treatments.
12. What the Result Does, and Does Not, Mean
The registry record establishes that RE-DAX was designed as a randomized, open-label, parallel-group study of Adhansia XR and Concerta for ADHD. It specifies a primary symptom-scale change outcome for adults treated with Adhansia XR, describes the scale, and lists several secondary outcomes, including a between-group TASS assessment intended to establish non-inferiority. It also records safety counts and that the study was terminated.
Those design details do not answer whether symptoms changed by month 2, how large any change was, or how precisely it was estimated. The primary outcome result is not reported in the registry record. No comparative estimate for Adhansia XR versus Concerta is reported for the primary endpoint, and the record does not provide results for the listed non-inferiority outcome. Therefore, neither the primary nor the comparative treatment question can be answered from the outcome information recorded.
A within-group change, if reported, would describe observed change over time in the Adhansia XR adult population. It would not by itself show that the change was caused by treatment or that it differed from change under Concerta. A comparative conclusion would require a reported contrast and its uncertainty, together with the analysis details and assumptions. For non-inferiority, interpretation would also require the margin and appropriate evidence relative to that margin; these are not reported in the registry record.
The adverse-event counts are descriptive. They do not establish comparative safety, causation, or the likelihood of an event over a particular duration, because event timing, exposure, and comparative analyses are not reported. Similarly, enrollment and termination status cannot substitute for endpoint estimates or explain why outcome results are absent. The record supports a careful account of the intended study questions and some recorded safety counts, but not a conclusion about treatment effectiveness or comparative effects.
13. Why This Trial Matters Statistically
This study is statistically notable for the difference between its broad comparative purpose and the wording of its primary outcome. The record describes an active comparator and a randomized parallel design, while the primary endpoint focuses on change among adults treated with Adhansia XR. That distinction is important: a within-group change and a between-group treatment contrast answer different questions. The listed secondary TASS outcome addresses a comparative non-inferiority question, but its results and margin are not reported in the registry record.
The primary endpoint also highlights the importance of defining the analysis population. The record specifies an adult Full Analysis Set consisting of randomly assigned patients who took at least one dose, while the study title and description refer to adults and adolescents. A population definition helps readers understand whom an estimate would represent, but the record does not report the number analyzed or participant characteristics for this endpoint.
Finally, the study status and absence of posted outcome estimates make transparency especially relevant. Termination is recorded, but its reason and consequences for follow-up or analysis are not reported in the registry record. Without an estimate and measure of uncertainty, readers cannot assess the magnitude, precision, or robustness of the planned primary outcome. These limits illustrate why registration details, analysis populations, complete outcome reporting, and clear distinctions between within-group and comparative questions all matter to 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 principal trial-specific limitation for interpretation is that numerical results for the primary endpoint are not reported in the registry record. Without the mean change, its standard deviation or other uncertainty measure, and the number analyzed, the endpoint cannot be evaluated for magnitude or precision. Results for the planned secondary outcomes are also not reported in the record described.
The primary outcome applies to adults treated with Adhansia XR, whereas the official title describes adult and adolescent patients and the study includes Concerta as an active comparator. The endpoint as written is not a direct comparison between treatment groups. The record does not report whether separate adolescent analyses were planned or conducted, and it does not provide a primary endpoint estimate for Concerta.
The trial is recorded as terminated, but the reason, timing, and implications for recruitment, follow-up, or analysis are not reported in the registry record. The record also does not report baseline characteristics, adherence, treatment discontinuation, concomitant care, missing-data patterns, model specifications, or a statistical analysis plan. These details would help readers assess representativeness, analysis choices, and potential bias.
The study is open-label, so treatment assignment was not masked. In general, awareness of treatment can influence participant reporting or other aspects of outcome assessment, especially for symptom and satisfaction measures. The record does not describe procedures to reduce or assess such influence. This is a design consideration, not evidence that the reported outcomes were biased.
The safety information is limited to counts and listed serious-event terms. Follow-up duration, exposure, event timing, and comparative analyses are not reported. The record therefore cannot support a detailed assessment of comparative safety from these counts alone.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) — NCT04507204.
- Registry record last updated 2023-07-27; status last verified 2023-07.
- Results first posted 2023-07-27.
- 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
RE-DAX (NCT04507204) was a Phase 4, randomized, open-label, parallel-group study of Adhansia XR and Concerta in patients with ADHD. It recorded enrollment of 267, a start date of 2020-07-30, a primary completion date of 2021-12-22, and a status of terminated. The official title describes a pragmatic real-world study of adult and adolescent patients in the United States.
The primary outcome was change in ADHD-RS-5 total score from baseline to month 2 among adults treated with Adhansia XR. Secondary outcomes included a between-group TASS assessment for non-inferiority and measures of clinical impression, treatment satisfaction, healthcare resource use, quality of life, work productivity, and sleep quality. Numerical results for the primary and secondary outcomes are not reported in the registry record.
Group-specific adverse-event counts are recorded, but the information does not include the detail needed for a comparative safety analysis. The reason for termination, statistical analysis plan, sample-size justification, and methods for missing data are not reported in the registry record.