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 Pilot Human Lab Study of Lacosamide in Alcohol Use Disorder (AUD) (NCT03897348), a randomized phase 2 study. The primary outcome is Tolerability (Number of Participants With Mild, Moderate, or Severe Adverse Events).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03897348 |
| Phase | Phase 2 |
| Condition | Alcohol Use Disorder |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | Triple |
| Enrollment | 4 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of California, San Francisco |
| Results posted | Yes |
2. Clinical Question
Population
People with alcohol use disorder (AUD) participating in a human laboratory study. The registry record lists enrollment of 4; further details about participant characteristics are not reported in the registry record.
Intervention
Single doses of lacosamide 100 mg and lacosamide 200 mg, each administered during an Alcohol Drinking Paradigm (ADP) session. The study description also identifies alcohol craving, consumption, and subjective effects as outcomes of interest.
Comparator
Placebo administered during an ADP session. The crossover sequences list placebo and both lacosamide doses, with a 1 week washout period between sessions.
Primary question
How many participants had mild, moderate, or severe adverse events for each intervention during the study sessions? The primary endpoint is a count of participants, not a measure of alcohol consumption or craving.
The clinical question is about tolerability within a brief, controlled human laboratory setting. The registry describes a pilot feasibility study intended to assess lacosamide's effects on drinking and craving, and to assess the feasibility of the ADP for future research. Those aims do not change the registered primary outcome: participant counts for adverse events at each intervention.
Alcohol consumption, craving, and subjective effects are listed as secondary outcomes. The registry record does not report results for those outcomes in the information available for this analysis. It also does not report a treatment-effect estimate or a statistical comparison for the primary endpoint. Accordingly, the available results answer only a descriptive part of the question: they give adverse-event counts by intervention, without a reported inferential analysis.
3. Trial Design
This phase 2 study is titled as a pilot human laboratory study of lacosamide in AUD. The registry record describes randomized allocation, triple masking, and a crossover model. Enrollment is listed as 4, and the study status is completed. The recorded start date is 2018-09-17 and the primary completion date is 2019-06-12.
The intervention descriptions identify placebo, lacosamide 100 mg, and lacosamide 200 mg. Four crossover sequences are described. Each sequence lists the three interventions across ADP Session 1, ADP Session 2, and ADP Session 3, with a 1 week washout period between sessions. The order differs between sequences. The registry record does not report how many participants were assigned to each sequence, whether every enrolled participant completed every session, or how many participants contributed data to each outcome.
In a crossover design, an individual can receive more than one intervention at different times. This allows comparisons to use within-participant information, but it also means that outcome data may be linked across sessions. The registry record does not report the analysis method used to account for that structure, nor does it describe how period or sequence effects were handled. Triple masking is recorded, but which people or roles were masked is not reported in the registry record.
The study's stated purpose includes assessing the feasibility of the ADP and informing future human laboratory research. A small pilot study can describe procedures and generate preliminary observations, but the registry record does not report a sample-size justification or a statistical plan for hypothesis testing. The posted adverse-event data therefore need to be read as descriptive counts, not as a complete account of the planned crossover analysis.
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: 4 of the 52 were randomized. Of the 48 not randomized, 5 declined to participate and 43 did not meet inclusion criteria.
ADP Session 1
| Stage | Crossover Sequence A: Placebo, Then Lacosamide 200 mg, Then Lacosamide 100 mg | Crossover Sequence B: Lacosamide 200 mg, Then Lacosamide 100 mg, Then Placebo | Crossover Sequence C: Lacosamide 200 mg, Then Placebo, Then Lacosamide 100 mg | Crossover Sequence D: Lacosamide 100 mg, Then Lacosamide 200 mg, Then Placebo |
|---|---|---|---|---|
| STARTED | 1 | 1 | 1 | 1 |
| COMPLETED | 1 | 1 | 1 | 1 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
ADP Session 2
| Stage | Crossover Sequence A: Placebo, Then Lacosamide 200 mg, Then Lacosamide 100 mg | Crossover Sequence B: Lacosamide 200 mg, Then Lacosamide 100 mg, Then Placebo | Crossover Sequence C: Lacosamide 200 mg, Then Placebo, Then Lacosamide 100 mg | Crossover Sequence D: Lacosamide 100 mg, Then Lacosamide 200 mg, Then Placebo |
|---|---|---|---|---|
| STARTED | 1 | 1 | 1 | 1 |
| COMPLETED | 1 | 1 | 1 | 1 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
ADP Session 3
| Stage | Crossover Sequence A: Placebo, Then Lacosamide 200 mg, Then Lacosamide 100 mg | Crossover Sequence B: Lacosamide 200 mg, Then Lacosamide 100 mg, Then Placebo | Crossover Sequence C: Lacosamide 200 mg, Then Placebo, Then Lacosamide 100 mg | Crossover Sequence D: Lacosamide 100 mg, Then Lacosamide 200 mg, Then Placebo |
|---|---|---|---|---|
| STARTED | 1 | 1 | 0 | 1 |
| COMPLETED | 1 | 1 | 0 | 1 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
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 | Crossover Sequence A: Placebo, Then Lacosamide 200 mg, Then Lacosamide 100 mg | Crossover Sequence B: Lacosamide 200 mg, Then Lacosamide 100 mg, Then Placebo | Crossover Sequence C: Lacosamide 200 mg, Then Placebo, Then Lacosamide 100 mg | Crossover Sequence D: Lacosamide 100 mg, Then Lacosamide 200 mg, Then Placebo | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 1 | 1 | 1 | 1 | 4 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 | 1 | 1 | 1 | 4 |
| 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 | 1 | 1 | 1 | 1 | 4 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 1 | 1 | 1 | 1 | 4 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
| 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 | 1 | 1 | 0 | 0 | 2 |
| Race (NIH/OMB): White | Participants | 0 | 0 | 1 | 1 | 2 |
| 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 |
| Region of Enrollment: United States | Participants | 1 | 1 | 1 | 1 | 4 |
6. Primary Endpoint
The registry lists the primary outcome as Tolerability (Number of Participants With Mild, Moderate, or Severe Adverse Events), measured over 3 days (1 day each for ADP Session 1, 2, and 3).
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with mild, moderate, or severe adverse events for each intervention: lacosamide 100 mg, lacosamide 200 mg, and placebo. Its timeframe is 3 days, described as 1 day for each ADP session. This endpoint focuses on whether participants experienced adverse events during the study exposures, rather than on how much alcohol they consumed or how strongly they reported craving.
Counting participants with events is a straightforward way to describe tolerability in a small laboratory study. It gives a reader an observable count in each intervention category. It does not, by itself, show the severity distribution, the timing of each event, or whether the same participant had events in more than one session. Although the endpoint title groups mild, moderate, and severe events, severity-specific results are not reported in the registry record.
The registry also lists alcohol craving, alcohol consumption measured as number of standard drinks consumed, and subjective effects of alcohol consumption as secondary outcomes. Those measures address the study's broader research aims, but they are distinct from the primary tolerability endpoint. Their results and the methods used to compare them are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record reports zero serious adverse events in each intervention category. For other adverse events, it reports 1 participant in the placebo category, 3 in the lacosamide 100 mg category, and 3 in the lacosamide 200 mg category. Deaths are reported as zero in each category. The corresponding numbers listed at risk are 4 for placebo, 3 for lacosamide 100 mg, and 4 for lacosamide 200 mg for other adverse events; for serious adverse events, the number at risk is 4 in each category.
These are descriptive counts, not estimates from a reported comparative analysis. The registry record does not provide confidence intervals, p-values, an adjusted treatment effect, or a statistical test for the primary endpoint. It does not report severity-specific counts or explain whether the adverse-event categories represent participants, event episodes, or both beyond the endpoint's stated participant-count definition. The posted results therefore do not support a precise estimate of comparative risk.
The intervention categories are part of a crossover study, and the same participant may contribute observations under different interventions. The registry record does not report participant-level patterns, sequence-specific data, or an analysis accounting for within-participant dependence. The counts should not be treated as though they necessarily came from independent groups. The listed numbers at risk also differ for other adverse events; reasons for that difference are not reported in the registry record.
The primary outcome is not reduced to a single comparison in the registry record, and the number of analyses listed is zero. Thus, the posted counts cannot establish whether the observed differences reflect intervention effects, chance variation, exposure differences, or other features of the study. With enrollment of 4, the data are especially limited for estimating uncommon events or comparing interventions precisely. The registry record does not state a threshold for a meaningful difference, and no such threshold should be inferred from these counts.
The figures are most appropriately read as a record of what was counted in this pilot, not as definitive evidence about tolerability or the effects of lacosamide. Results for the stated secondary outcomes are not reported in the registry record, so the drinking and craving questions remain unanswered by the reported data.
9. Statistical Methods Explained
The registry describes randomized allocation, triple masking, and a crossover model. It does not report a detailed statistical analysis plan. The concepts below explain how such design features generally affect interpretation; they are not claims about analyses that were actually conducted.
What does a crossover design change?
In a crossover study, participants receive different interventions in a planned sequence. The registry lists four sequences involving placebo, lacosamide 100 mg, and lacosamide 200 mg, with a 1 week washout period between ADP sessions. General statistical principle: because a participant can contribute results under multiple interventions, observations within that participant are related. An analysis that treats each intervention category as a wholly separate set of people can misstate uncertainty. A suitable analysis usually needs to account for the repeated observations and the design's sequence and period structure. The method used in this study is not reported in the registry record.
Washout periods are intended in general to separate intervention periods, but their duration alone does not establish that carryover is absent. The registry record does not report whether carryover was assessed, how session order was handled in an analysis, or whether any design checks were planned. These details matter because an outcome in a later session might be related to a prior intervention or to being in a later period.
How should event counts be understood?
The primary endpoint is a participant count for adverse events, grouped by intervention. General statistical principle: counts retain the scale of the observed data and can be useful for describing a small pilot. They are not automatically comparable measures of risk if the number of participants with observed data or the amount of exposure differs between categories. Here, the registry lists different numbers at risk for other adverse events, and it does not explain the difference. It also does not provide participant-level data or a comparative estimate.
A count of participants with an event differs from a count of event episodes: one participant can experience more than one event. The primary endpoint is described in terms of participants, but the posted information does not give event-level detail or a severity breakdown. Consequently, the counts cannot show whether affected participants had one event or several, how severe events were, or when events occurred within the study timeframe.
What would an uncertainty interval add?
General explanation: a confidence interval expresses the range of effect estimates compatible with the data and a specified statistical procedure. It conveys precision as well as the direction and size of an estimate. A narrow interval generally indicates greater precision than a wide interval, while an interval spanning a broad range indicates substantial uncertainty. No confidence intervals are reported for the primary endpoint in the registry record. With such limited enrollment, any comparative estimate would need particularly careful interpretation, but no interval can be reconstructed from the posted counts alone without making assumptions and having the necessary analysis details.
A p-value, when calculated under a defined model, describes how compatible observed data are with a specified null model. It is not the probability that an intervention works, and it does not measure clinical importance. The registry record does not report a p-value or statistical test for the primary endpoint. No conclusion about statistical significance can therefore be drawn from the posted counts.
What do the planning illustrations mean?
General explanation: sample-size planning uses assumptions about the effect to detect, the significance level, allocation, and the statistical model. The registry's planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; they also describe planning for stated fractions of an observed effect. These are planning illustrations based on an observed effect, not evidence of observed power. They are not the trial's own design justification. The registry record does not report a sample-size justification for this pilot, and no planning result can replace a reported treatment-effect estimate or uncertainty interval.
The record does not report analyses for the primary outcome, and the listed analysis count is zero. The endpoint is also not reduced to a single comparison. The planning assumptions should therefore not be mistaken for a completed hypothesis test or for a formal analysis of the crossover data. Any interpretation of the posted results must remain descriptive unless a suitable analysis is reported.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary tolerability endpoint and secondary outcomes covering alcohol craving, alcohol consumption measured as number of standard drinks consumed, and subjective effects of alcohol consumption. It also lists 6 outcome measures and zero analyses. No multiplicity strategy is reported in the registry record.
General explanation: when researchers examine several outcomes, doses, time points, or pairwise comparisons, the chance of at least one apparently notable result can increase. A prespecified hierarchy, adjustment procedure, or clear designation of exploratory analyses can help readers understand how multiple tests were handled. The registry record does not report whether such an approach was planned. It also does not identify which comparisons, if any, were intended as confirmatory.
The primary outcome is not reduced to one comparison in the registry record. The posted information does not establish how the three intervention categories were to be compared statistically or whether the severity levels were to be analyzed separately. Results for the secondary outcomes are not reported in the registry record, so their estimates and uncertainty cannot be assessed.
Missing-data handling is not reported in the registry record. The record does not explain whether there were missed sessions, incomplete outcome assessments, withdrawals, or exclusions from any analysis. The analysis populations are also not reported: it is not possible to determine from the registry information whether the analyses were intended to include all randomized participants, only participants who completed sessions, or another population. The differing numbers listed at risk for other adverse events are visible in the posted counts, but the reason is not reported. These omissions limit interpretation of both the denominators and the completeness of the outcome data.
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 |
|---|---|---|---|
| Placebo | 0 | 4 | 0.0% |
| Lacosamide 100 mg | 0 | 3 | 0.0% |
| Lacosamide 200 mg | 0 | 4 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Placebo | 0 of 4 |
| Lacosamide 100 mg | 0 of 3 |
| Lacosamide 200 mg | 0 of 4 |
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 |
|---|---|
| Placebo | 1 of 4 |
| Lacosamide 100 mg | 3 of 3 |
| Lacosamide 200 mg | 3 of 4 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | Lacosamide 100 mg | Lacosamide 200 mg |
|---|---|---|---|---|
| Sleepiness | General disorders | 1 of 4 | 3 of 3 | 3 of 4 |
| Headache | Nervous system disorders | 1 of 4 | 1 of 3 | 1 of 4 |
| Nausea | Gastrointestinal disorders | 1 of 4 | 1 of 3 | 1 of 4 |
| Sensation of spinning | Nervous system disorders | 0 of 4 | 1 of 3 | 2 of 4 |
| Dizziness | Nervous system disorders | 0 of 4 | 1 of 3 | 1 of 4 |
| Fatigue | General disorders | 0 of 4 | 0 of 3 | 1 of 4 |
| Double Vision | Eye disorders | 0 of 4 | 0 of 3 | 1 of 4 |
| Loss of coordination of muscle movements | Nervous system disorders | 0 of 4 | 1 of 3 | 0 of 4 |
| Vomiting | Gastrointestinal disorders | 0 of 4 | 0 of 3 | 0 of 4 |
| Tremor | Nervous system disorders | 0 of 4 | 0 of 3 | 0 of 4 |
The registry reports no serious adverse events in the placebo, lacosamide 100 mg, or lacosamide 200 mg categories. The number listed at risk for serious adverse events is 4 for each category. Deaths are listed as zero for each intervention.
For other adverse events, the registry reports 1 affected participant in the placebo category, 3 in the lacosamide 100 mg category, and 3 in the lacosamide 200 mg category. The numbers listed at risk are 4, 3, and 4, respectively. These are counts, not percentages or comparative risk estimates. No percentages, confidence intervals, or statistical tests for the safety counts are reported in the registry record.
Because this is a crossover study, the intervention categories should not automatically be read as independent groups of participants. The registry record does not identify which participants experienced events across sessions, give event-level timing, or provide severity-specific counts. The primary endpoint includes mild, moderate, and severe events, while the posted safety summary separates serious events from other events; the record does not give enough detail to map each reported other event to a primary-endpoint severity level.
12. What the Result Does, and Does Not, Mean
The posted results show the adverse-event counts recorded for the intervention categories and report no serious adverse events or deaths. They do not provide a statistical comparison of lacosamide with placebo, an estimate of uncertainty, or results for alcohol craving, consumption, and subjective effects. The record therefore offers a limited descriptive account rather than a complete answer to the study's broader research aims.
These data do not establish that lacosamide caused or prevented any event. The crossover design, small enrollment, differing numbers listed at risk for other adverse events, and absence of participant-level information make a simple comparison of counts difficult to interpret. The registry record does not report how repeated observations were analyzed, whether all sessions were completed, or how missing data were handled.
The absence of reported serious adverse events in these categories is a description of the recorded results, not proof that serious events cannot occur. A small pilot is not positioned by the registry record as a definitive test of uncommon outcomes. Likewise, the counts for other adverse events do not, on their own, establish a difference between interventions. No medical conclusion should be drawn from the registry counts alone.
The study was intended to assess feasibility as well as explore lacosamide effects in a human laboratory paradigm. Its registry record does not report sufficient analysis detail to judge whether the ADP was feasible or whether the study's secondary outcomes changed across interventions. Those questions require results and methods that are not reported in the registry record.
13. Why This Trial Matters Statistically
This study illustrates why design information and analysis details matter when reading a small clinical experiment. A randomized, masked crossover design can support within-participant comparisons in principle, but it also creates dependence between observations from the same participant. Counts organized by intervention do not reveal how that dependence was handled. Without participant-level results or a reported model, the descriptive counts cannot be treated as a full crossover comparison.
The pilot and feasibility aims also shape what can reasonably be learned. The registry describes a human laboratory study intended to inform future research, with enrollment of 4. That context makes transparent reporting of procedures, session completion, missing outcomes, and analysis plans especially useful. Those details would help readers distinguish feasibility findings from preliminary outcome observations. Several are not reported in the registry record.
The primary endpoint is a participant count for adverse events, while the study's broader aims involve drinking and craving. Keeping those questions separate is important: a safety count does not answer an alcohol-consumption question, and an intended secondary measure is not a result. The registry record lists the secondary outcomes but does not report their findings.
Finally, reporting counts alongside denominators is informative, but it does not substitute for uncertainty estimates or an analysis suited to the design. The record supplies a descriptive snapshot and enough design context to identify important interpretive limits, while leaving the comparative effects and precision unresolved.
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 primary endpoint's stated timeframe spans 3 days, with 1 day assigned to each ADP session. The registry record does not explain whether adverse events were collected only during session days or whether events outside those periods were captured. The timing of events and their relationship to each intervention are not reported.
Although the endpoint refers to mild, moderate, or severe adverse events, no severity-specific results are reported. The posted safety categories distinguish serious events from other adverse events, but the registry record does not clarify how those categories correspond to the primary endpoint's severity groupings. It is also unclear from the reported information whether participants could be counted in more than one intervention category because of events during different crossover periods.
The registry describes four sequences and a 1 week washout period, but does not report sequence assignment counts, completion by session, or participant-level outcome data. It does not report how period effects, sequence effects, or possible carryover were addressed. The number listed at risk for other adverse events is not the same across intervention categories, and a reason is not reported.
Further limitations include the absence of a reported sample-size justification, statistical analysis plan, missing-data approach, analysis population, confidence intervals, and primary-outcome test. No findings for the listed secondary outcomes are reported. These gaps prevent assessment of comparative precision, the handling of repeated observations, and the extent to which the stated feasibility and drinking-related aims were met.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Pilot Human Lab Study of Lacosamide in Alcohol Use Disorder (AUD) — NCT03897348.
- Registry record last updated 2022-06-28; status last verified 2022-06.
- Results first posted 2021-10-27.
- 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
NCT03897348 is a completed phase 2 randomized, triple-masked crossover pilot study of lacosamide in AUD, sponsored by the University of California, San Francisco. Enrollment is listed as 4. The registry describes placebo, lacosamide 100 mg, and lacosamide 200 mg across ADP sessions, with a 1 week washout period between sessions.
The primary outcome is the number of participants with mild, moderate, or severe adverse events during the 3-day study timeframe. The registry reports zero serious adverse events and zero deaths in each intervention category. Other adverse-event counts are 1 for placebo, 3 for lacosamide 100 mg, and 3 for lacosamide 200 mg. No primary-outcome analysis, uncertainty estimates, or secondary-outcome results are reported in the registry record.