Dasotraline Binge Eating Disorder Extension Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Dasotraline Binge Eating Disorder Extension Study (NCT02684279), a na phase 3 study. The primary outcome is Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS).

2. Clinical Question

At a broad level, the study was intended to describe longer-term safety and tolerability during dasotraline treatment in adults with binge-eating disorder. Its official title identifies it as an extension study, but the circumstances of entry into the extension and any preceding treatment are not reported in the registry record. The study was open-label and had no control group, so the main question that can be addressed from the posted information is descriptive: what safety outcomes were recorded among participants receiving dasotraline? The available primary-outcome description identifies the measure and assessment period, but not the results needed to characterize changes in suicidal ideation or behavior.

3. Trial Design

The registry identifies NCT02684279 as a phase 3, multicenter, open-label extension study of dasotraline in adults with binge-eating disorder. It is marked completed. The study began on 2016-02-29, and the primary completion date is 2019-06-24. Enrollment is listed as 533. The intervention is dasotraline, with flexible dosing at 4, 6, or 8 mg.

The design is single-group, with allocation listed as not applicable and no masking. There is no randomized control arm in the registry record. Consequently, observations during treatment can describe outcomes in the study group, but they do not provide a randomized estimate of what would have happened under a different treatment or without treatment. Open-label status also means participants and study personnel were not masked to treatment assignment; further details about outcome assessment procedures are not reported in the registry record.

The primary outcome is described as frequency and severity of suicidal ideation using the C-SSRS, with the timeframe from baseline to Week 52. The record separately lists secondary outcomes concerning body weight, body mass index, and fasting lipid measures. It lists 20 outcome measures overall. The study’s detailed visit schedule, analysis populations, dose-adjustment procedures, and statistical plan are not reported in the registry record.

The study title characterizes it as an extension, but the registry record does not describe how participants entered it or provide details of any earlier study phase. Therefore, the design should be understood from the record as an open-label, single-group treatment study, without assuming that all enrolled participants had the same prior treatment history or exposure.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: A total 533 subjects were enrolled in this study. Five subjects did not receive any dose of study medication.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Safety- please note: one subject had no value for Suicidal Ideation or Suicidal Behavior

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.

Population: safety

6. Primary Endpoint

The registry lists the primary outcome as Frequency and Severity of Suicidal Ideation Using the Columbia-suicide Severity Rating Scale (C-SSRS), measured over Baseline to Week 52.

The primary outcome concerns the frequency and severity of suicidal ideation measured with the Columbia-Suicide Severity Rating Scale. The registry describes a severity scale ranging from 0, meaning no ideation present, to 5, meaning active ideation with plan and intent. A score of 4 or 5 indicates serious suicidal ideation. The outcome timeframe is baseline to Week 52, and the stated unit is participants.

The record also describes collecting suicidal behavior as the presence or absence of actual attempts, non-suicidal self-injurious behavior, interrupted attempts, aborted attempts, preparatory acts or behavior, and any suicidal behavior. This is distinct from the severity rating for ideation: one describes reported thoughts and their severity, while the other records specified behaviors. The registry’s primary outcome title emphasizes ideation, while its description includes both ideation and behavior.

Such measures are used in safety monitoring because they track clinically important events over the study period. A participant count can show how many people met a defined outcome, but it does not by itself describe the timing, duration, or change in an individual’s experience. The registry record does not report the primary-outcome counts, score distributions, or change estimates. It notes that one subject had no value for suicidal ideation or suicidal behavior, but does not explain how that missing value was handled in the analysis.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a single-group study, so the basic statistical reading is descriptive. Descriptive statistics characterize what was observed among participants in the study. In a binary outcome, each participant is classified according to whether the event was recorded, and a count can be reported. The record’s primary outcome is expressed in participants, but the outcome counts themselves are not reported in the registry record. Without those counts, no outcome proportion or change estimate can be interpreted from the primary endpoint description alone.

What does a participant count tell the reader?

A participant count describes how many people met a specified outcome definition during the stated observation period. It is not necessarily the same as a count of all event episodes: one person may experience more than one event, while a participant-level outcome typically counts whether the person met the definition. The registry identifies the unit as participants for the primary outcome. It does not provide a breakdown of repeated events or clarify every operational detail of how primary-outcome counts were assembled.

For adverse events, a count is most useful when read with its corresponding number at risk and with the event definition. The record reports a serious-adverse-event count and an at-risk count, and separately reports counts for other adverse events. Those are descriptive summaries of the study group. They do not establish that the intervention caused an event. Causal interpretation would require suitable comparisons and additional information, neither of which is reported for these counts.

Why does the single-group design matter?

In a randomized comparison, groups are assigned to different interventions under a common design, allowing an estimate of the difference between groups. Here, the registry identifies a single group, no allocation, and no masking. There is therefore no randomized treatment contrast to estimate. Changes over time may be described if the relevant results are reported, but a before-and-after pattern alone cannot identify what would have happened to the same participants without treatment. This is a general limitation of uncontrolled observations, not a claim about the direction of any outcome in this study.

Open-label status means treatment knowledge was not masked. In general, awareness of treatment can influence reporting, behavior, or assessment, depending on the outcome and how it is measured. The C-SSRS provides a defined rating framework, but the registry record does not describe assessor training, independent assessment, or other procedures that might affect measurement. Those details are not reported in the registry record.

How should uncertainty be understood?

In general, a confidence interval expresses uncertainty around an estimate, with the interval’s width reflecting how precisely the data estimate the quantity under the statistical model. A narrow interval indicates greater precision than a wide interval, but neither is a substitute for understanding study design or measurement. The registry record does not report confidence intervals for the primary outcome or the adverse-event counts. No interval-based precision claim can therefore be made from the posted information.

A significance test, in general, evaluates data relative to a specified statistical model and null hypothesis. A p-value is not a measure of clinical importance, and it does not correct weaknesses in the design. The registry record does not report a primary-outcome test result or a statistical plan specifying such a test. No conclusion about statistical significance is available from the primary outcome description.

What do the sample-size assumptions represent?

The registry record describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the effect to detect as a stated fraction of the observed effect. These are planning assumptions, not evidence that this trial used a two-arm design: the study itself is listed as single-group with no allocation. The planning illustration is not observed power, and its assumptions do not establish the study’s own design rationale. Numerical planning results and the trial’s sample-size justification are not reported in the registry record.

More generally, a sample-size calculation asks how much information might be needed under specified assumptions to detect a target effect at a chosen error rate. Its result depends on the assumed effect, variability, allocation, and analysis model. It should not be read as proof that an effect was present or that a completed study had a particular probability of success. Those distinctions are especially important when planning assumptions refer to a comparison that is not the design of the study being interpreted.

What is not available for re-analysis?

The registry record supplies no primary-outcome result values, no analysis estimates, and no analysis details sufficient to reproduce an adjusted or unadjusted effect estimate. It also does not report the statistical plan, model specifications, or treatment of missing primary-outcome data. Recalculation from summary statistics is therefore not possible from this record. Any numerical description should be limited to the adverse-event counts and other values explicitly reported, without deriving additional measures.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 20 outcome measures, including a primary outcome and secondary outcomes involving body weight, body mass index, and fasting lipid measures. When a study assesses multiple outcomes, multiplicity can arise if many statistical tests are conducted: the chance of at least one false-positive result may increase unless the analysis plan addresses that issue. This is a general statistical concern, not evidence that a particular adjustment was or was not used in this study. The statistical plan, hierarchy of secondary outcomes, and any multiplicity adjustment are not reported in the registry record.

The record lists 0 analyses and does not provide numerical results for the primary outcome. Thus, there are no reported endpoint tests or estimates from which to assess multiplicity handling. The number of outcome measures alone does not reveal how many were tested, how they were prioritized, or whether results were adjusted.

For missing data, the primary-outcome description notes that one subject had no value for suicidal ideation or suicidal behavior. The registry record does not explain why the value was missing, whether the missingness applied to both measures in the same way, or how the subject was handled in any analysis. It does not report an imputation method, a complete-case analysis, or a sensitivity analysis. In general, missing-data methods can affect estimates when the available observations differ systematically from those that are missing. Without the analysis details and results, the impact of the missing value cannot be assessed.

The analysis populations, including any distinction between enrolled participants and those contributing to each outcome, are not reported in the registry record. The enrollment count should not be assumed to be the denominator for every endpoint or safety analysis.

11. 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 serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: anaemia (0.2%), iron deficiency anaemia (0.2%), abdominal adhesions (0.2%), colitis (0.2%), rectal haemorrhage (0.2%).

The registry record lists one study group, Dasotraline. It reports 528 participants at risk for serious adverse events, with 21 affected. For other adverse events, it reports 528 at risk and 295 affected. It records 0 deaths. These figures are participant counts as presented in the record; they should not be treated as comparative risks because there is no control group.

The listed serious-event terms are Anaemia, Iron deficiency anaemia, Abdominal adhesions, Colitis, Rectal haemorrhage, and Cholecystitis. Each is shown with a frequency of 0.2%. These are the top serious terms listed in the record, not a complete account of all events. The record does not provide event timing, duration, recurrence, or information sufficient to determine whether an event was caused by treatment. A serious adverse event is not necessarily an event caused by the study intervention.

The at-risk counts are the relevant denominators reported for these safety summaries; the enrollment figure is not a substitute denominator for every analysis. The registry record does not describe exposure duration for each participant or provide further detail about how the safety categories were defined. These counts can describe what the record reports, but cannot establish a treatment effect or be directly compared with outcomes from a different study without considering differences in design and ascertainment.

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

This study is statistically informative as an open-label, single-group extension focused on longer-term safety and tolerability in adults with binge-eating disorder. The primary outcome is defined using the C-SSRS and spans baseline to Week 52. The registry also reports selected adverse-event counts. These details help identify what was measured and how the study was structured.

The posted information does not report the primary outcome counts or changes, so it cannot establish the frequency or course of suicidal ideation or behavior during the study. Nor does it provide numerical results for the listed secondary outcomes concerning weight, body mass index, or fasting lipids. The registry’s outcome descriptions should not be mistaken for findings: specifying a measure does not show what its result was.

The adverse-event summaries report 21 participants affected by serious adverse events among 528 at risk, 295 affected by other adverse events among 528 at risk, and 0 deaths. These counts are descriptive. In the absence of a randomized comparator, they do not show whether the outcomes were more or less common than they would have been under another treatment or no treatment. Event counts alone also do not establish that dasotraline caused an event.

Accordingly, this record does not establish efficacy, comparative safety, or a causal relationship between treatment and any reported event. It also does not establish that no unreported outcome occurred. The findings that can be stated are limited to the design and values recorded in the registry; broader conclusions require results and analysis details that are not reported in the registry record.

13. Why This Trial Matters Statistically

Extension studies address a different statistical question from randomized efficacy trials. They can document outcomes during continued observation and can add descriptive information about safety over time. Their interpretation depends on who enters the extension, how long participants are observed, how outcomes are assessed, and how missing information is handled. For this study, the registry identifies an open-label, single-group design and a Week 52 primary-outcome timeframe, but does not report many of those supporting details.

The study’s structure is important when interpreting the reported safety counts. A count in one group can describe observed events, but cannot by itself distinguish treatment effects from background events, changes over time, or characteristics of people who entered and remained in the study. The absence of a randomized comparator is therefore central to what can be inferred—not a minor technical detail.

The primary measure also illustrates why outcome definition and outcome results must be kept separate. The registry describes a graded scale for suicidal ideation and a separate collection of suicidal behaviors, but does not report their participant counts or score results. Knowing the measurement framework clarifies the intended assessment, yet it does not substitute for the observed data or their uncertainty.

Finally, the listed safety counts and the missing primary-outcome result demonstrate why registry interpretation should distinguish available information from absent information. A completed study and a detailed outcome description do not guarantee that numerical findings or analysis methods are present in the record. Clear reporting of denominators, outcome estimates, uncertainty, missing-data handling, and the analysis population would be needed for a fuller statistical assessment.

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 record is the single-group, open-label design. Without a randomized comparator, outcome counts during treatment cannot be interpreted as the difference caused by treatment. Lack of masking may also affect reporting or assessment, although the direction and extent of any influence cannot be determined from the registry record.

The registry does not report the primary endpoint’s numerical results, including participant counts, score distributions, or changes from baseline. It also does not report results for the listed secondary outcomes concerning body weight, body mass index, or fasting lipid measures. Therefore, the endpoint descriptions cannot support conclusions about the direction or magnitude of change.

Important design and analysis details are not reported in the registry record. These include the rules for flexible dosing, participant entry into the extension, duration of individual exposure, analysis populations, assessor procedures, statistical methods, handling of missing data, and any multiplicity approach. The record notes one subject had no value for suicidal ideation or suicidal behavior, but does not describe the handling or implications of that missing information.

The adverse-event information is limited to counts, at-risk counts, selected serious-event terms, and deaths. It does not provide event timing, duration, recurrence, exposure-adjusted summaries, or attribution sufficient to determine causality. With no comparator, the reported counts cannot establish relative safety. Enrollment is listed as 533, but the registry separately lists 528 at risk for the safety summaries; the record does not explain this difference, and the enrollment number should not be substituted for the stated safety denominators.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Dasotraline Binge Eating Disorder Extension Study — NCT02684279.
• Registry record last updated 2020-08-12; status last verified 2020-07.
• Results first posted 2020-08-12.
• 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

NCT02684279 is a completed phase 3, multicenter, open-label, single-group extension study of dasotraline in adults with binge-eating disorder. Enrollment is listed as 533. Flexible doses were 4, 6, or 8 mg. The study began on 2016-02-29, with primary completion on 2019-06-24.

The primary outcome was frequency and severity of suicidal ideation using the C-SSRS from baseline to Week 52; the description also includes suicidal behavior. One subject had no value for suicidal ideation or suicidal behavior. The registry record does not report numerical primary-outcome results.

Safety summaries list 21 participants with serious adverse events among 528 at risk, 295 with other adverse events among 528 at risk, and 0 deaths. The record lists 20 outcome measures and does not provide a randomized comparison, primary statistical results, or details of the statistical analysis plan.