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 A Study of the Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis (NCT00477672), a randomized phase 3 study. The primary outcome is Antipsychotic Efficacy.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00477672 |
| Phase | Phase 3 |
| Condition | Parkinson's Disease Psychosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 298 |
| Arms in the primary outcome | n/a |
| Lead sponsor | ACADIA Pharmaceuticals Inc. |
| Results posted | Yes |
2. Clinical Question
Population
People with Parkinson’s disease psychosis who met the trial’s eligibility criteria. The primary analysis population was defined as participants who received at least one dose of study drug and had a baseline SAPS assessment plus at least one post-baseline SAPS assessment. The registry record does not report additional eligibility details in the information available for this analysis.
Intervention
Pimavanserin tartrate, also identified as ACP-103, taken as a tablet by mouth once daily for 6 weeks. The trial included a 10 mg dose and a 40 mg dose.
Comparator
A placebo tablet taken by mouth once daily for 6 weeks. The study was randomized, placebo-controlled, double-blind, and described as quadruple-masked.
Primary question
Whether changes in hallucinations and delusions, measured by the SAPS H+D score from baseline to Day 42, differed across the pimavanserin dose groups and placebo. A negative change in score was defined as improvement. The registry record does not report the primary outcome comparison needed to answer this question.
This is a question about comparative change in a symptom scale, not simply whether participants improved during the study. To assess a treatment contrast, the change in each dose group must be considered in relation to the change in the placebo group, with its uncertainty. Improvement within a group alone would not establish that the group changed differently from placebo.
The trial also listed change in motor symptoms as a secondary outcome. That measure addresses a different clinical domain from hallucinations and delusions, so it should not be treated as a substitute for the primary psychosis measure. The record identifies the motor-symptom outcome but does not provide a result for it in the information.
3. Trial Design
The registry describes a Phase 3, randomized, parallel-group study of pimavanserin in patients with Parkinson’s disease psychosis. It was placebo-controlled and quadruple-masked; the official title also describes it as multicenter and double-blind. The registry lists enrollment of 298 and a completed study. The recorded study start was 2007-06, and primary completion was 2009-06.
Participants were assigned to one of three regimens: placebo, pimavanserin 10 mg, or pimavanserin 40 mg. Each was given as a tablet once daily by mouth for 6 weeks. A parallel design means participants receive an assigned regimen rather than crossing between study regimens during the trial. Randomization is intended to support a fair comparison by making treatment assignment independent of participants’ observed and unobserved characteristics, on average; it does not guarantee that every characteristic will be balanced in a particular trial.
The registry gives no details about the random sequence generation, allocation concealment, or the people included in the masking designation. Those operational details are not reported in the registry record. The planned enrollment is not described as a justification, and the record does not state the assumptions or calculations used to choose it. A reason for the enrollment target is therefore not reported in the registry record.
The primary outcome was defined using the Scale for the Assessment of Positive Symptoms – Hallucinations and Delusions scales, abbreviated SAPS-H+D in its description and SAPS H+D in the outcome title. The described primary change was from baseline on Day 1 to Day 42, with measures also listed at study visits on Days 1, 8, 15, 29, and 42. The registry also lists a secondary outcome concerning change in motor symptoms. The record identifies two outcome measures, but does not give a testing hierarchy or clarify how repeated visits and multiple dose comparisons were handled in the inferential plan.
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 | Placebo | Pimavanserin 10 mg | Pimavanserin 40 mg |
|---|---|---|---|
| STARTED | 98 | 101 | 99 |
| COMPLETED | 91 | 85 | 83 |
| NOT COMPLETED | 7 | 16 | 16 |
Reasons for not completing this period:
| Reason | Placebo | Pimavanserin 10 mg | Pimavanserin 40 mg |
|---|---|---|---|
| Adverse Event | 3 | 5 | 6 |
| Death | 0 | 1 | 0 |
| Disease progression | 0 | 1 | 0 |
| Physician Decision | 1 | 0 | 0 |
| Protocol noncompliance | 0 | 2 | 0 |
| Consent withdrawn | 2 | 5 | 10 |
| Discretion of Sponsor | 1 | 2 | 0 |
Analysis population for the primary outcome, as defined in the registry: This is the "Intent to Treat" population, defined as patients who received at least one dose of study drug, and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment.
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 Analysis Set
| Characteristic | Unit | Placebo | Pimavanserin 10 mg | Pimavanserin 40 mg | Total |
|---|---|---|---|---|---|
| Participants analysed | 98 | 99 | 98 | 295 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 27 | 30 | 23 | 80 |
| Age, Categorical: >=65 years | Participants | 71 | 69 | 75 | 215 |
| Age, Continuous | years | 69.6 (SD 9.67) | 69.0 (SD 8.61) | 69.4 (SD 7.84) | 69.3 (SD 8.71) |
| Sex: Female, Male: Female | Participants | 47 | 36 | 24 | 107 |
| Sex: Female, Male: Male | Participants | 51 | 63 | 74 | 188 |
| Region of Enrollment: United States | participants | 44 | 45 | 45 | 134 |
| Region of Enrollment: India | participants | 10 | 10 | 10 | 30 |
| Region of Enrollment: Europe | participants | 44 | 44 | 43 | 131 |
6. Primary Endpoint
The registry lists the primary outcome as Antipsychotic Efficacy, measured over Each study visit (i.e. Days 1, 8, 15, 29 and 42).
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | Score on the SAPS H+D scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint concerns antipsychotic efficacy, defined in the registry as a decrease in the severity and/or frequency of hallucinations and/or delusions. It is measured as change from baseline to Day 42 in the SAPS-H+D score for the stated analysis population. The possible total score is 0 to 100, and a negative change indicates improvement. The outcome is expressed as a least-squares mean with a 95% confidence interval in the registry’s endpoint description.
A symptom scale turns observations about severity and frequency into a structured measure that can be compared across treatment groups. Change from baseline focuses the comparison on how scores move during the study, rather than only on the score at the endpoint. Comparing changes between randomized groups is important because participants can have different starting scores, and their symptoms may change over time for reasons other than the assigned study regimen.
The endpoint is therefore intended to capture the average pattern of change in the specified population, while the confidence interval describes uncertainty around an estimate. A confidence interval is a statistical range constructed by a method that reflects the estimate’s precision under its assumptions; it is not a guarantee that the true value lies inside that particular interval.
The stated endpoint is specific to hallucinations and delusions, not to all symptoms of Parkinson’s disease or to motor symptoms. Although the record describes the endpoint and its scoring direction, it does not report the treatment-group estimates or their confidence intervals. The size, precision, and between-group pattern of the primary outcome cannot therefore be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes what the trial set out to compare, but it does not provide the numerical primary-outcome results needed to interpret efficacy. It describes changes in SAPS H+D from baseline to Day 42 and states that negative change indicates improvement. However, no treatment-group least-squares means, confidence intervals, or inferential comparisons are reported in the information available for this analysis. The record lists zero analyses, and the primary outcome has several categories or time points that were not reduced to one comparison.
That absence matters because the endpoint’s direction alone does not reveal what happened in the trial. A definition that a negative score change is improvement is an interpretation rule for the scale, not an observed result. Similarly, the presence of placebo and two dose groups does not reveal whether their changes were alike or different. Without the estimates and their uncertainty, no conclusion about the size, direction, or precision of a treatment contrast can be drawn from this registry record.
The primary endpoint description says that an analysis of covariance was used and that missing data were imputed using last observation carried forward. These method labels identify the planned or reported analytic approach, but they do not replace the results. The available record also does not report p-values, adjusted comparisons, or an analysis accounting for the multiple dose groups and repeated visit measurements. Such details should not be inferred from the fact that an endpoint was specified.
Safety information is reported as event counts among participants at risk in each group. The registry lists serious adverse events for placebo and both pimavanserin doses, as well as counts for other adverse events. Those counts can describe what was recorded in the trial, but they do not establish causation or provide a full account of an event’s timing, duration, severity, or relationship to study treatment. The registry’s death fields are null, which means death counts are not reported in the registry record; it does not establish that no deaths occurred.
Any sample-size planning illustration should be read as conditional on its stated assumptions, not as a description of observed outcomes or as evidence that the trial had adequate power. The planning assumptions use an effect based on the observed effect, but the registry record does not report the primary outcome estimates needed for readers to assess their clinical or statistical meaning. Planning calculations do not supply missing trial results.
Overall, the record supports an account of the design, endpoint, analytic method, and selected safety counts. It does not support a quantitative efficacy conclusion. The appropriate interpretation is that the registry record does not report the primary outcome comparison, not that the comparison showed no difference or that it favored any group.
9. Statistical Methods Explained
The statistical methods named for the primary outcome are analysis of covariance, least-squares means, and last observation carried forward for missing data. These methods describe how outcome data may be modeled and summarized, but they do not by themselves reveal the estimated treatment effects. The registry record does not provide the model coefficients, group estimates, confidence intervals, or test results needed to evaluate the comparison.
What does analysis of covariance do?
Analysis of covariance, often abbreviated ANCOVA, compares an outcome across groups while accounting for one or more covariates. In a baseline-adjusted analysis, the model can account for the starting value of the outcome when estimating group differences at follow-up. This may improve precision when baseline values are related to follow-up values, and it can address chance baseline imbalance in a randomized study. That general explanation does not establish which covariates were included in this trial’s model; the specific covariates and model specification are not reported in the registry record.
A least-squares mean is a model-based estimate of a group mean after accounting for the covariates included in the model. It is not necessarily identical to the simple arithmetic mean of the observed scores. For interpretation, the estimate needs its scale, the contrast being made, and a measure of uncertainty. The registry names least-squares means and a 95% confidence interval, but does not report the corresponding endpoint values or a specific between-group contrast in the available results.
How should the confidence interval be read?
In general, a confidence interval conveys the precision of an estimate under the statistical model and its assumptions. A narrower interval indicates greater precision than a wider interval for the same kind of estimate. The interval should be interpreted with the estimated effect, because an interval without its estimate does not describe the direction or magnitude of the result. It also does not show whether an analysis was adjusted for multiple comparisons unless that adjustment is described separately. The registry record gives the interval type for the primary outcome but not the interval values.
What does last observation carried forward mean?
Last observation carried forward, or LOCF, fills a missing follow-up value using a participant’s most recent recorded value. It is an imputation rule: it creates an analysis value for a missing measurement rather than observing the participant’s score at that time. As a general matter, this approach assumes that the most recent recorded value is a reasonable stand-in for the unobserved value. That assumption can be inappropriate if symptoms would have changed after the last observation, and the direction of any resulting bias depends on why data are missing and how outcomes evolve.
The registry states that LOCF was used, but does not report the extent or pattern of missingness, the number of values imputed, or sensitivity analyses using alternative approaches. It is therefore not possible to assess how strongly the primary analysis depended on this imputation rule. A complete interpretation would also consider whether participants who discontinued differed from those who remained under observation.
Why can over-dispersion matter?
In general, over-dispersion describes variability greater than a statistical model expects. It is especially relevant to count outcomes, where a model that understates variability can produce confidence intervals that are too narrow and tests that appear more precise than they should. The primary outcome in this trial is described as a continuous score, and the registry specifies ANCOVA rather than a count model. Over-dispersion is therefore not identified as a specific issue for the listed primary analysis. More broadly, the spread and distribution of the score still matter to model fit, but diagnostic information is not reported in the registry record.
What does randomization contribute?
In general, random assignment supports causal comparisons by reducing systematic differences in treatment assignment. It does not prevent missing outcomes, measurement error, chance imbalance, or deviations from assigned treatment. The analysis population described for the primary endpoint includes participants who received at least one dose and had both a baseline SAPS assessment and at least one post-baseline SAPS assessment. That definition excludes some randomized participants if they did not meet those criteria, so it is important to distinguish the registry’s stated analysis population from an assumption that every randomized participant was analyzed.
The registry record does not describe the randomization sequence, allocation concealment, covariate list, model diagnostics, or sensitivity analyses. It also does not report the primary estimates. Those omissions limit assessment of both the model’s implementation and the robustness of its findings.
10. Multiplicity, Missing Data and Analysis Populations
The trial included two pimavanserin dose groups and a placebo group, and its primary outcome description covers multiple visits. These features create more than one possible treatment contrast and more than one possible time-specific result. When several statistical tests are conducted, the chance of at least one apparently unusual result can increase. General methods for addressing multiplicity include prespecifying a primary contrast, adjusting significance thresholds, or using a structured testing procedure. The registry record does not report whether any such approach was planned or used, so no multiplicity adjustment should be assumed.
The endpoint description identifies change from baseline to Day 42, while the timeframe also lists study visits on Days 1, 8, 15, 29, and 42. The registry states that the primary outcome has several categories or time points and does not reduce it to one comparison. It therefore does not provide a single reported comparison from which to assess the main treatment contrast. The statistical plan for selecting or interpreting results across visits is not reported in the registry record.
For missing outcome data, the record names last observation carried forward. It does not state how many participants had missing observations, the reasons for missingness, how missingness differed across groups, or whether alternative missing-data analyses were conducted. General statistical practice treats these details as important because an imputation method rests on assumptions about unobserved outcomes. The registry record does not provide enough information to evaluate those assumptions in this trial.
The primary analysis population is defined as participants who received at least one dose and had both a baseline SAPS assessment and at least one post-baseline SAPS assessment. This definition is more specific than simply referring to all randomized participants. The registry does not report how many participants met the definition in each group or how excluded randomized participants were handled. The implications of that selection for the comparison cannot be assessed from the available record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Placebo | 2 | 98 | 2.0% |
| Pimavanserin 10 mg | 5 | 99 | 5.1% |
| Pimavanserin 40 mg | 5 | 98 | 5.1% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5.00% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Placebo | 34 of 98 |
| Pimavanserin 10 mg | 29 of 99 |
| Pimavanserin 40 mg | 27 of 98 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo | Pimavanserin 10 mg | Pimavanserin 40 mg |
|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | 1 of 98 | 0 of 99 | 0 of 98 |
| Myocardial infarction | Cardiac disorders | 0 of 98 | 1 of 99 | 0 of 98 |
| Gastrointestinal hemorrhage | Gastrointestinal disorders | 1 of 98 | 0 of 99 | 0 of 98 |
| Bronchitis | Infections and infestations | 1 of 98 | 0 of 99 | 0 of 98 |
| Cellulitis | Infections and infestations | 0 of 98 | 1 of 99 | 0 of 98 |
| Sepsis | Infections and infestations | 0 of 98 | 1 of 99 | 0 of 98 |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 98 | 0 of 99 | 1 of 98 |
| Encephalopathy | Nervous system disorders | 0 of 98 | 1 of 99 | 0 of 98 |
| Headache | Nervous system disorders | 0 of 98 | 0 of 99 | 1 of 98 |
| Syncope | Nervous system disorders | 0 of 98 | 1 of 99 | 0 of 98 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | Pimavanserin 10 mg | Pimavanserin 40 mg |
|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | 11 of 98 | 5 of 99 | 4 of 98 |
| Dizziness | Nervous system disorders | 4 of 98 | 7 of 99 | 7 of 98 |
| Nausea | Gastrointestinal disorders | 4 of 98 | 4 of 99 | 8 of 98 |
| Orthostatic hypotension | Vascular disorders | 9 of 98 | 4 of 99 | 2 of 98 |
| Headache | Nervous system disorders | 6 of 98 | 4 of 99 | 4 of 98 |
| Confusional state | Psychiatric disorders | 3 of 98 | 5 of 99 | 5 of 98 |
| Constipation | Gastrointestinal disorders | 3 of 98 | 4 of 99 | 5 of 98 |
| Edema | General disorders | 1 of 98 | 2 of 99 | 7 of 98 |
Serious events with the highest arm-level rate: anemia (1.0%), gastrointestinal hemorrhage (1.0%), bronchitis (1.0%), breast cancer (1.0%), headache (1.0%).
The registry reports serious adverse event counts among participants at risk: 2 of 98 for placebo, 5 of 99 for pimavanserin 10 mg, and 5 of 98 for pimavanserin 40 mg. It also reports other adverse event counts of 34 of 98, 29 of 99, and 27 of 98, respectively. These are counts within the listed risk groups; they should not be read as treatment effects or as proof that a study drug caused or prevented an event.
The registry lists anemia, gastrointestinal hemorrhage, bronchitis, breast cancer, headache, and confusional state among the serious adverse event terms, each with a reported frequency of 1.0%. The information available does not link each term to a particular treatment group or provide details about the event narratives. The term list therefore cannot establish group-specific risks or explain clinical circumstances.
Adverse-event counts depend on how events were defined, collected, and classified. The registry record does not provide event onset, duration, severity beyond the serious classification, relatedness assessments, or exposure-adjusted rates. The deaths fields are null, so death counts are not reported in the registry record. Missing death counts must not be interpreted as confirmation that no deaths occurred. These safety figures are descriptive and should be considered alongside the limits of the reported detail.
12. What the Result Does, and Does Not, Mean
The registry record shows that a randomized, placebo-controlled trial was conducted to compare two pimavanserin doses with placebo in Parkinson’s disease psychosis. It specifies the primary symptom measure, its direction of scoring, the follow-up period, the analysis population, and the use of ANCOVA with LOCF for missing data. It also reports selected adverse-event counts. These details describe the trial’s framework and some of its recorded safety information.
The record does not report the primary-outcome estimates or the comparisons among groups. As a result, it cannot show the magnitude or precision of any difference in SAPS H+D change. The absence of a reported result is not evidence that groups were equal, nor does it indicate that a difference was statistically significant. Neither interpretation can be supported without the estimates and their uncertainty.
The symptom scale’s possible total score and the rule that negative change indicates improvement help readers understand how a result would be interpreted if the values were available. They do not reveal what participants experienced. Likewise, a study design intended to compare randomized groups does not establish the result of that comparison. The registry entry describes a completed trial, but completion status is not a finding about efficacy or safety.
The posted adverse-event counts are useful as a limited description of events recorded among participants at risk. They do not establish whether an event was caused by treatment, and the record does not provide enough detail to interpret event timing, exposure, or group-specific serious-event terms. The null death fields are unreported values, not evidence of zero deaths.
Any sample-size illustration is a planning calculation based on explicit assumptions, not an observed-power analysis and not a replacement for the outcome results. In general, planning estimates can help show how sample size relates to a target effect and a chosen statistical framework. They cannot tell readers whether the trial achieved a particular effect or whether an unreported comparison supports a conclusion. The registry’s own design rationale is not reported in the registry record.
The most defensible reading is therefore limited: the registry identifies a relevant randomized comparison and describes how the primary outcome was defined and analyzed, but it does not report the primary comparison itself. No conclusion about whether one regimen differed from placebo can be drawn from the posted results described in this record.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the difference between a well-described endpoint and a reported endpoint result. The registry defines a continuous symptom score, gives the direction of improvement, names the analysis method, and identifies a missing-data procedure. Those details are necessary for understanding a result, but they are not enough to estimate the treatment contrast when the group values and confidence intervals are absent.
The design also raises questions that are common in multi-arm trials. With two active doses and placebo, readers need to know which comparisons were prespecified and how the family of tests was handled. Repeated visits add another layer: an endpoint can be tracked over time while a particular visit or contrast is designated as primary. Without a stated hierarchy or multiplicity approach, the record does not show how the possible comparisons were organized for inference.
The analysis population and missing-data method are also important to statistical interpretation. The stated population requires treatment exposure and both baseline and post-baseline assessments, while LOCF fills missing measurements using earlier observations. These choices affect which participants contribute and how their outcomes enter the analysis. The registry does not report the details needed to judge the impact of these choices, including missingness patterns or alternative analyses.
Finally, the safety counts illustrate why descriptive event summaries need careful framing. Counts among participants at risk can identify events recorded during a trial, but they do not by themselves establish causation or fully characterize risk. Denominators, event definitions, exposure, timing, and uncertainty all matter. The record’s null death fields further demonstrate the distinction between an unreported value and a verified absence of events.
For statistical readers, the central lesson is that endpoint definitions, analysis methods, and numerical results are separate elements of evidence. A registry entry can document the first two while leaving the third unavailable. That distinction prevents design information from being mistaken for a finding.
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 limitation is that the registry record does not report the primary outcome estimates or the comparisons needed to interpret the trial’s efficacy question. It gives no group-level least-squares means, confidence intervals, or test results in the information available for this analysis. Consequently, the size and precision of the primary effect cannot be assessed.
The record describes the primary endpoint at multiple visits, while the outcome was not reduced to one comparison. It does not report a prespecified testing hierarchy, multiplicity adjustment, or the approach used to handle the dose-group comparisons. This limits interpretation of any potential inferential results, even apart from the absence of the estimates.
Although ANCOVA and LOCF are named, the registry does not report the model covariates, model diagnostics, extent of missing data, reasons for missingness, or sensitivity analyses. The primary analysis population is defined, but the number meeting that definition by group and the handling of participants outside it are not reported in the registry record. The impact of the analysis population and imputation choices therefore cannot be evaluated.
Safety reporting is also limited. The record gives event counts and a short list of serious adverse event terms, but not detailed event narratives, timing, duration, exposure, or treatment-relatedness assessments. Death counts are not reported in the registry record. The available counts should not be treated as complete evidence about comparative safety.
Finally, the record does not report a sample-size justification, the randomization and allocation-concealment procedures, or the identities covered by the masking designation. It describes enrollment and completion, but these details do not establish the trial’s statistical power or resolve the missing result information. The limitations arise from what the registry record reports, rather than from an inference that the trial had a particular outcome.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of the Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis — NCT00477672.
- Registry record last updated 2017-05-17; status last verified 2017-04.
- Results first posted 2014-03-26.
- 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
NCT00477672 is a completed Phase 3 randomized, parallel-group, placebo-controlled trial of pimavanserin in Parkinson’s disease psychosis. The registry lists enrollment of 298 and describes once-daily oral treatment for 6 weeks with placebo, pimavanserin 10 mg, or pimavanserin 40 mg. The recorded start was 2007-06, and primary completion was 2009-06.
The primary endpoint was change from baseline to Day 42 in SAPS H+D, with negative change defined as improvement. The registry describes an ANCOVA analysis and LOCF imputation, and defines the analysis population by study-drug exposure and availability of baseline and post-baseline SAPS assessments. It also lists motor-symptom change as a secondary outcome.
The primary outcome comparison is not reported in the registry record. Serious and other adverse-event counts are available by group, but the event details are limited, and death counts are not reported in the registry record. The study design and methods can be described, but the missing efficacy estimates prevent a quantitative interpretation of the primary comparison.