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 Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetic/Efficacy (NCT01677377), a non-randomized phase 2 study. The primary outcome is Summary of Participants With Treatment-Emergent Adverse Events (TEAE).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01677377 |
| Phase | Phase 2 |
| Condition | Schizophrenia |
| Allocation | Non-Randomized |
| Design model | Factorial |
| Masking | None (open label) |
| Enrollment | 45 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Indivior Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Participants with clinically stable schizophrenia entered the study. The registry reports 45 participants enrolled, with 15 in each of three cohorts. Cohort entry followed an oral risperidone run-in: participants in the 60 mg cohort were stable on 2 mg oral daily risperidone, those in the 90 mg cohort on 3 mg, and those in the 120 mg cohort on 4 mg.
Intervention
Participants received three single, unblinded subcutaneous injections of risperidone in RBP-7000 at their cohort dose. Injections occurred on study days 1, 29 and 57. After the injection period, participants returned to their cohort’s oral daily risperidone dose on days 85-87.
Comparator
The registry describes three dose cohorts, not a randomized control group. It does not report a like-for-like control comparison. The cohort doses were 60 mg, 90 mg and 120 mg; each cohort also had a different oral risperidone dose during run-in and after the injection period.
Primary question
The primary endpoint summarizes participants with treatment-emergent adverse events from day 1 to day 106 in the safety population. The study’s stated aim was to evaluate safety and tolerability across multiple subcutaneous doses. It also included pharmacokinetic and pharmacodynamic outcomes, but their results are not reported in the registry record.
This clinical question is primarily descriptive: what adverse-event experience was recorded in each cohort during the study period? The design does not establish a randomized contrast between doses. Cohort-level counts can describe what happened among participants receiving each regimen, but differences between cohorts cannot be attributed to dose alone from these data.
3. Trial Design
This was a Phase 2A, open-label, multiple ascending dose study of subcutaneous risperidone in RBP-7000. The registry lists a non-randomized allocation and no masking. Enrollment was 45, and the study status is completed. The start is recorded as 2012-08 and primary completion as 2013-04. The registry identifies Indivior Inc. as the sponsor.
Participants were assigned to three dose cohorts. In Cohort 1, participants stable on 2 mg oral daily risperidone during run-in received 60 mg subcutaneous injections on study days 1, 29 and 57, then returned to 2 mg oral daily risperidone on days 85-87. Cohort 2 followed the corresponding schedule with 90 mg injections and 3 mg oral daily risperidone. Cohort 3 followed it with 120 mg injections and 4 mg oral daily risperidone. Each cohort included 15 participants.
The open-label design means treatment assignment was not masked. Because allocation was non-randomized and the cohorts also differed in the oral dose used during run-in and return to oral treatment, their outcomes are not a like-for-like randomized comparison. The registry lists the study model as factorial, but a detailed explanation of that designation is not reported in the registry record.
The primary endpoint was a summary of participants with treatment-emergent adverse events during day 1 to day 106. The safety population was specified for that outcome. Secondary outcomes included symptom ratings, movement-related scales, and suicidal ideation or behavior measures at baseline and specified follow-up days. The registry lists 64 outcome measures, but the results of those secondary outcomes are not reported in the registry record. A detailed protocol, including the rationale for the cohort sizes and dose selection, is not reported in the registry record.
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: This was an open-label, Phase 2A, multiple-ascending dose study performed at 2 sites in the U.S. Seventy subjects were screened and 45 subjects were enrolled and received RBP-7000.
Overall Study
| Stage | Cohort 1, RBP-7000 60 mg | Cohort 2, RBP-7000 90 mg | Cohort 3, RBP-7000 120 mg |
|---|---|---|---|
| STARTED | 15 | 15 | 15 |
| COMPLETED | 14 | 14 | 9 |
| NOT COMPLETED | 1 | 1 | 6 |
Reasons for not completing this period:
| Reason | Cohort 1, RBP-7000 60 mg | Cohort 2, RBP-7000 90 mg | Cohort 3, RBP-7000 120 mg |
|---|---|---|---|
| Protocol Violation | 1 | 0 | 0 |
| Lost to Follow-up | 0 | 1 | 1 |
| Withdrawal by Subject | 0 | 0 | 3 |
| Lack of Efficacy | 0 | 0 | 1 |
| Pregnancy | 0 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Safety population
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
| Characteristic | Unit | Cohort 1, RBP-7000 60 mg | Cohort 2, RBP-7000 90 mg | Cohort 3, RBP-7000 120 mg | Total |
|---|---|---|---|---|---|
| Participants analysed | 15 | 15 | 15 | 45 | |
| Age, Continuous | years | 43.7 (SD 9.98) | 42.5 (SD 9.93) | 41.7 (SD 7.96) | 42.6 (SD 9.16) |
| Sex: Female, Male: Female | Participants | 7 | 4 | 1 | 12 |
| Sex: Female, Male: Male | Participants | 8 | 11 | 14 | 33 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 2 | 0 | 3 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 14 | 13 | 15 | 42 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized: White | Participants | 7 | 4 | 4 | 15 |
| Race/Ethnicity, Customized: Black or African American | Participants | 7 | 11 | 10 | 28 |
| Race/Ethnicity, Customized: American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Asian | Participants | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Other | Participants | 1 | 0 | 1 | 2 |
| Weight | kg | 83.76 (SD 16.279) | 84.07 (SD 13.707) | 92.63 (SD 14.075) | 86.82 (SD 14.980) |
| Height | cm | 172.19 (SD 8.731) | 175.50 (SD 11.137) | 174.41 (SD 8.346) | 174.03 (SD 9.372) |
| Body Mass Index | kg/m^2 | 28.13 (SD 4.487) | 27.35 (SD 4.176) | 30.43 (SD 3.911) | 28.64 (SD 4.309) |
| Cytochrome P450 2D6 (CYP-2D6): Intermediate | Participants | 3 | 0 | 1 | 4 |
| Cytochrome P450 2D6 (CYP-2D6): Poor | Participants | 1 | 1 | 0 | 2 |
| Cytochrome P450 2D6 (CYP-2D6): Extensive | Participants | 11 | 14 | 14 | 39 |
6. Primary Endpoint
The registry lists the primary outcome as Summary of Participants With Treatment-Emergent Adverse Events (TEAE), measured over Day 1 to Day 106.
| 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 treatment-emergent adverse events (TEAEs) during day 1 to day 106, in the safety population. A TEAE is defined as an adverse event with a start date on or after the first study dose. The registry’s adverse-event definition includes a change in frequency or severity from a baseline event, whether the change is positive or negative, and regardless of whether the investigator considers the event related to study drug or medically significant.
This endpoint is used to describe safety and tolerability during exposure. Counting participants rather than events avoids counting one person repeatedly within the same category; the registry states that a participant with multiple experiences is counted once in a category, although the same participant may appear in different categories. This distinction matters: a participant count does not convey the total number of event episodes, their duration, or their severity beyond categories separately reported.
The endpoint’s time window begins on the first dosing day and extends to day 106. The registry also defines serious adverse events (SAEs) by outcomes such as death, a life-threatening event, hospitalization or prolonged hospitalization, persistent or significant disability or incapacity, or a congenital anomaly or birth defect. An event can be serious without being judged related to study drug. The endpoint is a descriptive safety measure, not a direct measure of symptom benefit. The registry’s stated definition and available counts do not provide detailed information about event timing, duration, management, or individual-level circumstances.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted safety counts show 15 participants at risk in each cohort. The serious adverse-event count was 0 in the 60 mg cohort, 0 in the 90 mg cohort, and 1 in the 120 mg cohort. No deaths were reported in any of the three cohorts. The counts for participants affected in the other adverse-event category were 11, 11 and 8, respectively. These are participant counts, not counts of all event episodes.
These observations describe the participants enrolled in this study; they do not establish that one dose is safer than another. Allocation was non-randomized, and there was no like-for-like control comparison. The cohorts also differed in their oral risperidone doses during run-in and after injections. The registry does not report adjusted comparisons or statistical tests for the safety counts. It reports zero analyses in the outcomes record.
Small cohort counts make the estimates imprecise as descriptions of a broader population. A count of zero observed events does not show that the underlying risk is zero; it means no event was recorded in that category among the participants at risk during the recorded period. Likewise, a nonzero count does not by itself establish causation. The TEAE definition includes events regardless of the investigator’s assessment of causal relationship, and the registry permits events to be judged related or not related to study drug.
The registry lists Psychotic disorder as the top serious term at 6.7%. The record excerpt does not state the cohort attribution for that term, so it should not be assigned to a particular dose group. The information does not supply confidence intervals, event-level narratives, or a formal comparison of rates. Those details are not reported in the registry record.
Other registered outcomes included Positive and Negative Syndrome Scale scores, Clinical Global Impression scores, AIMS, Simpson-Angus Scale, Barnes Akathisia Scale, and C-SSRS measures at baseline and follow-up. Their results are not reported in the registry record. Therefore, the posted adverse-event counts do not support conclusions about changes in symptoms, pharmacokinetics, or pharmacodynamic markers. They support only a limited descriptive reading of the recorded safety outcomes in these cohorts.
9. Statistical Methods Explained
What does a participant count represent?
The primary outcome is expressed as participants with an event. This is different from counting every event episode. If one participant has more than one adverse experience within a category, the registry’s rule counts that participant once in that category. A participant may still be counted in more than one category. Consequently, participant counts cannot reveal how often an event recurred within a person, and counts across distinct categories should not be assumed to represent different people.
The registry reports 15 participants at risk in each cohort. For serious events, the affected-participant counts are 0, 0 and 1 across the 60 mg, 90 mg and 120 mg cohorts. For the other adverse-event category, the counts are 11, 11 and 8. These are descriptive counts. No statistical comparison, confidence interval, or adjusted estimate is reported in the registry record.
What does treatment-emergent mean?
In general, treatment-emergent identifies an event by when it begins, not by whether treatment caused it. In this study, an event qualifies if its start date is on or after the first study dose. The registry definition also encompasses a positive or negative change in frequency or severity from a baseline event. The investigator may judge an event related or unrelated to study drug. Thus, the endpoint is not a count of events judged to have been caused by treatment.
The primary endpoint covers day 1 to day 106. That time boundary defines the period in which events are summarized, but the available counts do not show the exact onset dates, durations, or changes over time. General statistical interpretation: a time window helps define which observations contribute to an outcome, while the level of detail in the report determines what patterns can be examined.
Why does the design matter for comparisons?
General statistical explanation: random allocation can help balance measured and unmeasured participant characteristics between groups, on average. Here, allocation was non-randomized, and the registry explicitly notes that the arms are not a like-for-like control comparison. The cohort groups also correspond to different dose regimens and different oral risperidone doses. Any apparent variation in counts could reflect dose, cohort composition, other regimen differences, or chance; the posted results do not separate these possibilities.
The open-label design means participants and study personnel were not masked to treatment. This is relevant to subjective outcomes and to how events are reported or assessed, although the registry does not quantify any such influence. The safety endpoint includes investigator assessment of relatedness, but the primary event definition includes events regardless of that judgment.
How should uncertainty be understood?
General statistical explanation: a confidence interval gives a range of estimates compatible with the data under a specified statistical method. It can communicate precision as well as the central estimate. No confidence intervals are reported for the adverse-event counts in the registry record. For a small cohort, an observed count is particularly limited as a description of the range of outcomes that might occur in other participants. Zero recorded serious events in a cohort is not proof that the true probability is zero.
General statistical explanation: over-dispersion arises when observed variation is greater than a simple model assumes. It can make model-based uncertainty too narrow if the model does not account for that extra variability. The registry record does not report a model for these event counts, a dispersion assessment, or any use of an over-dispersion adjustment. This concept is relevant to count analysis generally, but it is not a reported method for this study.
What analysis was reported?
The registry record reports no analyses for the outcome results in this record. A detailed statistical analysis plan, including model specifications, adjustment variables, hypothesis tests, handling of repeated measures, and any interim analyses, is not reported in the registry record. Without those details, the reported counts should be read as descriptive rather than as evidence from a formal statistical comparison.
The registry’s sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation; the effect to detect is described as a fraction of the observed effect. Those assumptions are not a description of the actual non-randomized cohort design. The illustration is not observed power, and the registry does not report the study’s sample-size justification or a formal design calculation. The analysis outputs for such planning are not reported in the registry record.
General statistical explanation: power is a property of a design under assumptions about the effect, variability, allocation, and analysis. It cannot be inferred from whether a study did or did not observe a particular result. A planning sample size is not a measure of the evidence in completed data and should not be described as observed power.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 64 outcome measures and six groups of secondary outcomes, including symptom severity and improvement ratings, movement-related scales, and suicidal ideation or behavior. Many measures are recorded at baseline and multiple follow-up days. Examining many outcomes and time points can create a multiplicity concern: when numerous statistical tests are conducted, the chance of at least one apparently notable result may increase. General statistical practice may address this through a prespecified hierarchy, adjustment, or a clear distinction between confirmatory and exploratory analyses.
A multiplicity strategy, prespecified primary comparisons beyond the named endpoint, and statistical results for the secondary outcomes are not reported in the registry record. The record reports zero analyses for the outcome results. Therefore, no adjustment procedure or family of inferential tests can be evaluated from the posted information.
Missing-data methods are also not reported in the registry record. The registry identifies a safety population for the primary endpoint and provides 15 participants at risk in each cohort, but it does not describe exclusions, withdrawals, incomplete follow-up, or how unavailable event information was handled. A stated at-risk count alone does not explain whether every participant contributed information across the full day 1 to day 106 period.
The analysis populations for the secondary outcomes, and whether all randomized or treated participants were included in each analysis, are not reported in the registry record. Because allocation was non-randomized, there is no reported intention-to-treat comparison to interpret. Without information on missingness, analysis sets, and multiplicity, the safety counts remain descriptive and the broader outcome record cannot be fully assessed.
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 |
|---|---|---|---|
| Cohort 1, RBP-7000 60 mg | 0 | 15 | 0.0% |
| Cohort 2, RBP-7000 90 mg | 0 | 15 | 0.0% |
| Cohort 3, RBP-7000 120 mg | 1 | 15 | 6.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Cohort 1, RBP-7000 60 mg | 0 of 15 |
| Cohort 2, RBP-7000 90 mg | 0 of 15 |
| Cohort 3, RBP-7000 120 mg | 0 of 15 |
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 |
|---|---|
| Cohort 1, RBP-7000 60 mg | 11 of 15 |
| Cohort 2, RBP-7000 90 mg | 11 of 15 |
| Cohort 3, RBP-7000 120 mg | 8 of 15 |
Most frequent serious adverse event terms
| Event term | Organ system | Cohort 1, RBP-7000 60 mg | Cohort 2, RBP-7000 90 mg | Cohort 3, RBP-7000 120 mg |
|---|---|---|---|---|
| Psychotic disorder | Psychiatric disorders | 0 of 15 | 0 of 15 | 1 of 15 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cohort 1, RBP-7000 60 mg | Cohort 2, RBP-7000 90 mg | Cohort 3, RBP-7000 120 mg |
|---|---|---|---|---|
| Weight increased | Investigations | 4 of 15 | 5 of 15 | 3 of 15 |
| Headache | Nervous system disorders | 3 of 15 | 3 of 15 | 1 of 15 |
| Dyspepsia | Gastrointestinal disorders | 1 of 15 | 2 of 15 | 3 of 15 |
| Extrapyramidal disorder | Nervous system disorders | 2 of 15 | 1 of 15 | 1 of 15 |
| Cough | Respiratory, thoracic and mediastinal disorders | 0 of 15 | 1 of 15 | 3 of 15 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 1 of 15 | 2 of 15 | 0 of 15 |
| Somnolence | Nervous system disorders | 1 of 15 | 1 of 15 | 1 of 15 |
| Rash | Skin and subcutaneous tissue disorders | 3 of 15 | 0 of 15 | 0 of 15 |
| Abdominal pain upper | Gastrointestinal disorders | 2 of 15 | 0 of 15 | 0 of 15 |
| Toothache | Gastrointestinal disorders | 2 of 15 | 0 of 15 | 0 of 15 |
Serious events with the highest arm-level rate: psychotic disorder (6.7%).
The registry reports serious adverse events separately from the other adverse-event category. Among 15 participants at risk in each cohort, serious-event counts were 0 for Cohort 1, RBP-7000 60 mg; 0 for Cohort 2, RBP-7000 90 mg; and 1 for Cohort 3, RBP-7000 120 mg. Deaths were 0 in all three cohorts. These counts cover the study’s recorded safety period; the primary endpoint timeframe is day 1 to day 106.
The serious-event definition is based on specified consequences, including death, a life-threatening event, hospitalization or prolonged hospitalization, persistent or significant disability or incapacity, or a congenital anomaly or birth defect. Seriousness is not the same as severity, and seriousness does not establish that the study drug caused an event. The registry states that investigators assessed whether adverse events were related or unrelated to study drug.
The record lists Psychotic disorder as the top serious term at 6.7%, but does not report its cohort attribution in the available information. It should therefore not be assigned to any cohort. Counts of participants affected in the other adverse-event category were 11, 11 and 8 across the three cohorts. The counts describe participants, not the total number of event episodes. These data do not provide event narratives or a comparative statistical analysis.
12. What the Result Does, and Does Not, Mean
The results mean that the registry recorded adverse events among participants in each dose cohort during the study and recorded one serious adverse event in the 120 mg cohort. It recorded no serious adverse events in the 60 mg and 90 mg cohorts and no deaths in any cohort. The other adverse-event participant counts were 11 in the 60 mg cohort, 11 in the 90 mg cohort and 8 in the 120 mg cohort. These observations can be reported as cohort-specific descriptions of the enrolled participants.
They do not establish that the 120 mg regimen caused the serious event, or that any dose caused or prevented the other events. The event definition includes events regardless of whether the investigator judged them related to study drug. Nor do the counts establish that one cohort experienced a lower or higher underlying risk than another. Allocation was non-randomized, there was no like-for-like control comparison, and the cohorts had different oral risperidone doses during run-in and after injections.
The results also do not establish efficacy. The registered secondary outcomes include measures of symptoms, global clinical impression, movement-related effects, and suicidal ideation or behavior, but their results are not reported in the registry record. Pharmacokinetic and primary pharmacodynamic findings are part of the study’s official title, but their results are not reported in the registry record. No conclusions about those outcomes can be drawn from the adverse-event counts.
General statistical explanation: observed counts are estimates based on the participants and observation period available. Their uncertainty is not conveyed by a count alone. The registry record does not report confidence intervals or formal tests for these results. Zero observed events therefore does not imply zero risk in other participants or settings, and the nonzero counts cannot by themselves quantify an event probability outside this study.
The registry record supports a limited account of safety observations in three small non-randomized cohorts. It does not support a causal dose comparison or a conclusion about treatment benefit. Additional details, including event-level descriptions and missing-data handling, are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically instructive because it illustrates the difference between describing several groups and comparing them as if they were randomized arms. The registry lists three dose cohorts, but allocation was non-randomized and the groups were not a like-for-like control comparison. Participants also entered the cohorts on different oral risperidone doses. A visible difference in cohort counts is therefore not an isolated estimate of a dose effect.
The record also distinguishes participant counts from event counts. The endpoint counts a participant once within a category even if that participant has multiple adverse experiences. This makes the outcome interpretable as the number of participants affected, but it does not describe recurrence or total event burden. Seriousness is defined by specified consequences and is not interchangeable with causal attribution.
The study demonstrates why precision matters when interpreting small groups. Each cohort had 15 participants, and the registry does not provide confidence intervals or comparative tests for the event counts. General statistical explanation: uncertainty should be communicated alongside an estimate when possible, because the same observed count can be compatible with a range of underlying event rates. Without such measures, the reported counts should remain descriptive.
Finally, the breadth of registered outcomes matters. The registry lists 64 outcome measures, yet results for the symptom, movement, and other secondary measures are not reported in the registry record. Multiplicity methods and missing-data methods are also not reported. These omissions limit assessment of the complete statistical evidence, even though the posted safety counts remain useful as a record of observed events in the enrolled cohorts.
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.
Several limitations are specific to interpreting this study’s registry results. First, the allocation was non-randomized, and the record explicitly indicates that the cohorts are not a like-for-like control comparison. The cohorts also had different oral risperidone doses during run-in and after the injection period. This makes attribution of any cohort difference to the injection dose alone especially uncertain.
Second, the study was open-label with no masking. The registry does not describe procedures to limit possible influence on reporting or assessment. This matters particularly for outcomes involving judgments or participant reports, although the available record does not quantify any effect.
Third, each cohort included 15 participants. The registry provides counts but no confidence intervals, comparative tests, or adjusted analyses for the safety outcome. The recorded zero serious events in two cohorts should not be interpreted as evidence of zero underlying risk. The one serious event in the remaining cohort also cannot be causally attributed from the count alone.
Fourth, the registry lists 64 outcome measures but does not report results for the secondary outcomes in the information. A statistical analysis plan, missing-data procedures, analysis populations beyond the stated safety population, and multiplicity handling are not reported in the registry record. Details on withdrawals, follow-up completeness, event timing, and event narratives are also not reported in the registry record.
Finally, the listed serious-event term, Psychotic disorder at 6.7%, is not attributed to a cohort in the available record. It should not be used to characterize any specific dose group. These limitations restrict the conclusions to a descriptive account of the posted safety counts.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetic/Efficacy — NCT01677377.
- Registry record last updated 2018-10-23; status last verified 2018-10.
- Results first posted 2018-10-23.
- 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
The registry describes a completed Phase 2A, open-label, non-randomized study of three subcutaneous risperidone doses in RBP-7000 among participants with clinically stable schizophrenia. It records 45 participants enrolled, with 15 in each dose cohort. Participants received three injections on study days 1, 29 and 57, with cohort-specific oral risperidone dosing during run-in and after the injections.
The primary safety outcome summarizes participants with treatment-emergent adverse events from day 1 to day 106 in the safety population. Serious adverse-event counts were 0, 0 and 1 across the 60 mg, 90 mg and 120 mg cohorts; deaths were 0 in each. Other adverse-event participant counts were 11, 11 and 8. No formal analyses are reported for these results. The non-randomized design, small cohorts, and absence of reported uncertainty estimates limit comparisons. Secondary outcome results and several details of the statistical plan are not reported in the registry record.