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 to Evaluate the Intramuscular Administration of Scopolamine (NCT04314713), a randomized phase 1 study. The primary outcome is Determine Degree and Number of Adverse Events Experienced by Subjects..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04314713 |
| Phase | Phase 1 |
| Condition | Medical Countermeasures, Organophosphate Poisoning |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 32 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Battelle Memorial Institute |
| Results posted | Yes |
2. Clinical Question
Population
The registry describes a study of participants receiving intramuscular scopolamine hydrobromide trihydrate or placebo. It records total enrollment as 32, but participant characteristics, eligibility criteria, and the clinical setting are not reported in the registry record. The stated conditions are Medical Countermeasures and Organophosphate Poisoning. Those condition labels identify the context attached to the record; they do not establish that participants had organophosphate poisoning or that the study tested treatment of poisoning.
Intervention
The intervention was Scopolamine Hydrobromide Trihydrate administered by intramuscular injection, with ascending doses intended for evaluation. The four cohorts that proceeded are listed at 0.005 mg/kg, 0.007 mg/kg, 0.011 mg/kg, and 0.014 mg/kg. A fifth cohort was listed at 0.021 mg/kg, but no participants are recorded in that cohort.
Comparator
Placebo was the comparator. The record lists six cohort groups, including the four active-dose cohorts, the unfilled fifth-dose cohort, and placebo. Allocation details beyond the record’s randomized designation, including the method used to generate or implement the random sequence and the precise distribution procedure, are not reported in the registry record.
Primary question
The primary question was whether adverse events occurred, and to what degree, during the stated assessment period of 30 Days (+7), as a measure of the safety and tolerability profile of ascending intramuscular doses. The record also describes pharmacokinetics as an objective, but specific pharmacokinetic results are not reported in the registry record. On 13 June 2021, following DSMB recommendation and final sponsor decision, the PI was notified that enrollment would close and the study would not proceed to Cohort 5 (0.021 mg/kg).
3. Trial Design
This was a Phase 1, randomized, triple-masked, parallel-group, placebo-controlled, dose-escalation study. The intervention was intramuscular Scopolamine Hydrobromide Trihydrate. Its stated purpose was to characterize safety and tolerability across ascending doses and to characterize pharmacokinetics. The registry lists total enrollment as 32. It identifies Battelle Memorial Institute as the sponsor and records the study status as terminated.
The dose groups that have participants recorded are Cohort 1 at 0.005 mg/kg, Cohort 2 at 0.007 mg/kg, Cohort 3 at 0.011 mg/kg, and Cohort 4 at 0.014 mg/kg. The record also lists Cohort 5 at 0.021 mg/kg, but its at-risk count is zero. The primary outcome description explains that, following a DSMB recommendation and the sponsor’s final decision, the study closed to enrollment and did not proceed to Cohort 5. The placebo group is separately listed.
Randomized describes the allocation approach at a high level; the sequence-generation procedure, allocation concealment, and group assignment process are not reported in the registry record. The record identifies masking as triple, but does not specify which roles or individuals were masked. Further details about dose-escalation rules, cohort transitions, the placebo schedule, and treatment duration are not reported in the registry record.
The registry records a study start of 2020-06-02 and a primary completion date of 2021-04-06. It separately records the sponsor’s decision to close enrollment on 13 June 2021. These entries provide the timeline recorded for the trial, but do not by themselves explain the reasons for the termination beyond the stated DSMB recommendation and sponsor decision. The protocol, detailed statistical plan, and additional operational details are 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.
Overall Study
| Stage | Cohort 1 Scopolamine HBT 0.005 mg/kg | Cohort 2 Scopolamine HBT 0.007 mg/kg | Cohort 3 Scopolamine HBT 0.011 mg/kg | Cohort 4 Scopolamine HBT 0.014 mg/kg | Cohort 5 Scopolamine HBT 0.021 mg/kg | Placebo |
|---|---|---|---|---|---|---|
| STARTED | 6 | 6 | 6 | 6 | 0 | 8 |
| COMPLETED | 6 | 6 | 6 | 5 | 0 | 8 |
| NOT COMPLETED | 0 | 0 | 0 | 1 | 0 | 0 |
Reasons for not completing this period:
| Reason | Cohort 1 Scopolamine HBT 0.005 mg/kg | Cohort 2 Scopolamine HBT 0.007 mg/kg | Cohort 3 Scopolamine HBT 0.011 mg/kg | Cohort 4 Scopolamine HBT 0.014 mg/kg | Cohort 5 Scopolamine HBT 0.021 mg/kg | Placebo |
|---|---|---|---|---|---|---|
| Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: On 13 June 2021, following DSMB recommendation and final sponsor decision, the PI was notified of the sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
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: On 13 June 2021, following DSMB recommendation and final sponsor decision, the PI was notified of the sponsor's decision to close the study to enrollment and not proceed to Cohort 5 (0.021 mg/kg).
Only the first 6 of 7 groups are shown.
| Characteristic | Unit | Cohort 1 Scopolamine HBT 0.005 mg/kg | Cohort 2 Scopolamine HBT 0.007 mg/kg | Cohort 3 Scopolamine HBT 0.011 mg/kg | Cohort 4 Scopolamine HBT 0.014 mg/kg | Cohort 5 Scopolamine HBT 0.021 mg/kg | Placebo |
|---|---|---|---|---|---|---|---|
| Participants analysed | 6 | 6 | 6 | 6 | 0 | 8 | |
| Age, Customized: Age (years) mean | years | 34.8 (SD 9.6) | 34.8 (SD 9.11) | 31.7 (SD 10.31) | 35.7 (SD 11.48) | — | 32.6 (SD 10.07) |
| Sex: Female, Male: Female | Participants | 3 | 3 | 4 | 2 | — | 3 |
| Sex: Female, Male: Male | Participants | 3 | 3 | 2 | 4 | — | 5 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 3 | 1 | 2 | — | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 6 | 3 | 5 | 4 | — | 6 |
| 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 | 1 | — | 1 |
| 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 | 5 | 2 | 4 | 3 | — | 5 |
| Race (NIH/OMB): White | Participants | 0 | 4 | 2 | 1 | — | 2 |
| Race (NIH/OMB): More than one race | Participants | 1 | 0 | 0 | 1 | — | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 6 | 6 | 6 | 6 | — | 8 |
| Body Mass Index (BMI) | kg/m^2 | 24.55 (SD 3.454) | 25.58 (SD 2.143) | 24.17 (SD 1.876) | 25.95 (SD 2.669) | — | 24.58 (SD 2.232) |
6. Primary Endpoint
The registry lists the primary outcome as Determine Degree and Number of Adverse Events Experienced by Subjects., measured over 30 Days (+7).
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary outcome is described as determining the degree and number of adverse events experienced by participants. The outcome unit is participants, and its parameter is a count of participants. The stated assessment timeframe is 30 Days (+7). The record frames the endpoint as a way to characterize the safety and tolerability profile of ascending doses of intramuscular Scopolamine HBT.
Counting participants with an event can convey how many people in each group had at least one event of a specified type. This is distinct from counting the total number of event episodes: one participant may experience more than one event, while a participant-level count records that person once for the relevant category. The registry’s posted adverse-event information separately gives counts for participants at risk and participants affected by serious and other adverse events.
The outcome title also refers to the degree of adverse events, but details of severity grading, event definitions, relatedness assessment, and how the degree was summarized are not reported in the registry record. The record lists 11 outcome measures, but the additional outcome details and their results are not available in the registry record recorded for this analysis. The safety endpoint is descriptive in the material posted; no inferential analysis of the primary endpoint is listed in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted adverse-event counts show no serious adverse events among participants listed at risk in Cohorts 1 through 4 or in the placebo group. Each of those groups has zero serious events recorded among its participants at risk. Cohort 5 has zero participants at risk and zero serious events recorded, so it contributes no participant experience at that dose. The record also lists zero deaths in every group, including Cohort 5.
For other adverse events, the registry reports that 6 of 6 participants were affected in Cohort 1 at 0.005 mg/kg, 5 of 6 in Cohort 2 at 0.007 mg/kg, 6 of 6 in Cohort 3 at 0.011 mg/kg, and 6 of 6 in Cohort 4 at 0.014 mg/kg. In the placebo group, 5 of 8 participants were affected. Cohort 5 has no participants at risk and no other adverse events recorded. These are counts of participants affected, not counts of the total number of event episodes.
These counts describe what was posted for the enrolled groups; they do not establish whether the observed pattern is caused by the study drug. The record does not provide event-level descriptions, severity distributions, investigator assessments of relatedness, or statistical comparisons between dose groups and placebo. The registry lists zero analyses. Accordingly, there is no posted estimate of a between-group effect, no confidence interval to describe its precision, and no reported hypothesis test for the primary outcome.
The groups are small, and the fifth planned dose was not studied in enrolled participants. With limited observations, counts can describe the participants in each group but cannot provide a precise estimate of how frequently events might occur in a broader population. A zero count in a group does not prove that an event cannot occur; it means that none was recorded among the participants at risk in that group. Likewise, a participant-level count does not capture all details of event timing, duration, recurrence, or clinical importance.
The primary completion date is recorded as 2021-04-06, while the record also states that the study closed to enrollment and did not proceed to Cohort 5 after a DSMB recommendation and sponsor decision on 13 June 2021. The reason for the recommendation and the detailed decision process are not reported in the registry record. The stated termination and absence of a fifth-dose cohort should therefore be kept distinct from any interpretation of the adverse-event counts. The record does not support conclusions about comparative safety, pharmacokinetic behavior, or outcomes beyond the posted observations.
9. Statistical Methods Explained
The registry describes a randomized, triple-masked, parallel-group trial with placebo control and dose escalation. Those design terms describe broad features of how the study was organized; they do not supply the full protocol or the details needed to reproduce its analysis. The statistical methods used for the posted safety summaries are not reported in the registry record.
What does a participant count represent?
A participant count reports how many people meet a stated event definition. For a category such as serious adverse events, the at-risk count identifies the group size used for interpreting the event count, while the affected count identifies participants recorded with the event. This is a participant-level summary. It is not interchangeable with the number of event episodes, because one participant can have multiple episodes. The record gives counts for serious and other adverse events, but details of the underlying event definitions are not reported in the registry record.
Counts are especially useful for reading small groups because the observed number of affected participants remains visible rather than being reduced to a single model estimate. At the same time, counts alone do not characterize uncertainty fully. A confidence interval, when reported, expresses a range of values compatible with the data under a specified method and assumptions. No confidence intervals for these adverse-event summaries are reported in the registry record. No inferential analysis entries are listed, so there is no registry-reported statistical test or adjusted estimate to interpret.
Why do group size and exposure matter?
Interpretation depends on knowing who was at risk of being counted and over what period. The registry gives group-specific at-risk counts and a primary endpoint timeframe of 30 Days (+7). It does not report the detailed exposure definition, the exact observation schedule, or whether every participant had complete observation throughout that timeframe. If observation differs across participants, raw counts may not represent comparable opportunities to record events. The methods for handling such differences are not reported in the registry record.
Small groups can produce unstable estimates: a change in the experience of one participant can make a noticeable difference to a group’s count. This is a general statistical feature, not evidence that any particular count is incorrect. A zero event count is compatible with the absence of recorded events among the observed participants, but it cannot establish a zero underlying risk. The small group sizes and the lack of a fifth-dose cohort limit what can be inferred about the range of doses studied.
What do randomization and masking contribute?
In general, randomization is intended to reduce systematic differences between groups at assignment, while masking can reduce the influence of expectations on care, assessment, or reporting. The registry identifies the study as randomized and triple-masked. It does not report the randomization sequence, allocation concealment procedures, who was masked, or how masking was maintained. The labels alone therefore do not establish how successfully those procedures were implemented.
The parallel-group designation indicates that the record describes separate groups rather than a crossover design. The dose cohorts and placebo group are presented separately. Details of whether comparisons were planned between each dose and placebo, whether cohorts were enrolled sequentially, and what criteria governed dose escalation are not reported in the registry record. Those details matter because they can affect how group counts should be compared and how the overall study is interpreted.
How should dose escalation and termination be read?
The record lists ascending dose cohorts and states that the study would not proceed to Cohort 5 at 0.021 mg/kg following a DSMB recommendation and final sponsor decision. It does not report the stopping rule, the information considered by the DSMB, or whether the decision followed a formal statistical boundary. It would therefore be inappropriate to infer an interim-analysis method or a specific rationale from the termination entry alone. Interim analyses and stopping criteria are not reported in the registry record.
The record’s analysis count is zero. That indicates that no analyses are listed in the registry material summarized for this trial; it does not establish that no analyses were conducted outside the registry. No model specification, covariate adjustment, confidence interval method, missing-data approach, analysis population, or primary statistical testing procedure is reported in the registry record.
What is the role of planning calculations?
General planning calculations estimate how many participants may be needed to detect a prespecified effect under chosen assumptions. Such values are planning illustrations rather than observed trial outcomes, and they do not establish the power achieved by a completed study. The assumptions described for planning illustrations include a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects defined as fractions of the observed effect. No numerical planning estimates are reported in the registry record, and the trial’s own sample-size justification is not reported in the registry record. These planning assumptions should not be mistaken for the trial’s confirmed design rationale.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 11 outcome measures and zero analyses. The primary outcome concerns the degree and number of adverse events, while the study description also identifies pharmacokinetics as an objective. Specific details about how the outcomes were ordered, which were primary or secondary beyond the primary endpoint entry, and which comparisons were intended are not reported in the registry record.
When a study evaluates multiple outcomes, groups, time points, or comparisons, the chance of at least one apparently notable finding can increase if each is assessed separately. Statistical methods for addressing that issue may include prespecified testing hierarchies or adjustments, but no multiplicity strategy is reported in the registry record. The absence of listed analyses means there are no posted inferential results to evaluate for multiplicity adjustment.
Missing-data methods and analysis populations are also not reported in the registry record. The posted at-risk counts make the group sizes for the adverse-event summaries visible, but they do not describe withdrawals, incomplete observation, or the handling of missing outcome information. The record does not specify whether participants were analyzed according to randomized assignment, treatment received, or another population definition. These omissions limit assessment of how complete and comparable the outcome data were across groups.
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 Scopolamine HBT 0.005 mg/kg | 0 | 6 | 0.0% |
| Cohort 2 Scopolamine HBT 0.007 mg/kg | 0 | 6 | 0.0% |
| Cohort 3 Scopolamine HBT 0.011 mg/kg | 0 | 6 | 0.0% |
| Cohort 4 Scopolamine HBT 0.014 mg/kg | 0 | 6 | 0.0% |
| Placebo | 0 | 8 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Cohort 1 Scopolamine HBT 0.005 mg/kg | 0 of 6 |
| Cohort 2 Scopolamine HBT 0.007 mg/kg | 0 of 6 |
| Cohort 3 Scopolamine HBT 0.011 mg/kg | 0 of 6 |
| Cohort 4 Scopolamine HBT 0.014 mg/kg | 0 of 6 |
| Cohort 5 Scopolamine HBT 0.021 mg/kg | 0 of 0 |
| Placebo | 0 of 8 |
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 Scopolamine HBT 0.005 mg/kg | 6 of 6 |
| Cohort 2 Scopolamine HBT 0.007 mg/kg | 5 of 6 |
| Cohort 3 Scopolamine HBT 0.011 mg/kg | 6 of 6 |
| Cohort 4 Scopolamine HBT 0.014 mg/kg | 6 of 6 |
| Cohort 5 Scopolamine HBT 0.021 mg/kg | 0 of 0 |
| Placebo | 5 of 8 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cohort 1 Scopolamine HBT 0.005 mg/kg | Cohort 2 Scopolamine HBT 0.007 mg/kg | Cohort 3 Scopolamine HBT 0.011 mg/kg | Cohort 4 Scopolamine HBT 0.014 mg/kg | Cohort 5 Scopolamine HBT 0.021 mg/kg | Placebo |
|---|---|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | 2 of 6 | 3 of 6 | 6 of 6 | 5 of 6 | 0 of 0 | 1 of 8 |
| Dizziness | Nervous system disorders | 2 of 6 | 4 of 6 | 3 of 6 | 6 of 6 | 0 of 0 | 0 of 8 |
| Injection site pain | General disorders | 1 of 6 | 2 of 6 | 2 of 6 | 2 of 6 | 0 of 0 | 3 of 8 |
| Dry mouth | Gastrointestinal disorders | 4 of 6 | 3 of 6 | 2 of 6 | 1 of 6 | 0 of 0 | 0 of 8 |
| Injection site paraesthesia | General disorders | 2 of 6 | 1 of 6 | 0 of 6 | 2 of 6 | 0 of 0 | 2 of 8 |
| Headache | Nervous system disorders | 3 of 6 | 0 of 6 | 1 of 6 | 2 of 6 | 0 of 0 | 0 of 8 |
| Injection site hypoaesthesia | General disorders | 1 of 6 | 0 of 6 | 1 of 6 | 2 of 6 | 0 of 0 | 2 of 8 |
| Delirium | Psychiatric disorders | 0 of 6 | 0 of 6 | 0 of 6 | 3 of 6 | 0 of 0 | 0 of 8 |
The serious adverse-event counts are zero in Cohorts 1, 2, 3, and 4 and in the placebo group. Each of these groups has a nonzero at-risk count recorded. Cohort 5 also has zero serious events recorded, but its at-risk count is zero because no participants are recorded in that cohort. The registry lists zero deaths in all groups.
For other adverse events, the participant counts affected are 6 of 6 at 0.005 mg/kg, 5 of 6 at 0.007 mg/kg, 6 of 6 at 0.011 mg/kg, and 6 of 6 at 0.014 mg/kg. The placebo group has 5 of 8 participants affected. Cohort 5 has no participants at risk and no affected participants recorded. These are counts of people with an event, not counts of individual event episodes.
The record does not provide event descriptions, severity breakdowns, relatedness assessments, or details about incomplete follow-up. The counts should therefore be read as descriptive registry entries, not as adjusted comparisons or proof that one group had greater or lesser risk.
12. What the Result Does, and Does Not, Mean
The registry record documents a small Phase 1 dose-escalation study with four active-dose cohorts containing participants, a placebo group, and a fifth planned dose cohort without participants recorded. It reports participant counts for serious and other adverse events and states that the study was designed to characterize safety, tolerability, and pharmacokinetics. This is the scope of what the posted information can describe.
The adverse-event figures provide a count-based account of participants recorded as affected in each group. They do not provide a causal estimate of the effect of scopolamine relative to placebo. Without a reported comparative analysis, confidence intervals, event-level details, or information about the completeness of observation, the precision and comparability of the counts cannot be fully assessed. The small groups also mean that the observed participants cannot, by themselves, characterize outcomes across a broad population.
The absence of recorded serious adverse events in the groups with participants is a statement about the posted observations, not proof that serious events cannot occur. The absence of participants in Cohort 5 means the registry offers no enrolled-participant safety observations at 0.021 mg/kg. The cohort’s zero event count must not be interpreted as evidence about that dose’s safety.
The record does not report the results of the pharmacokinetic objective, and it does not provide details sufficient to assess the DSMB recommendation or the sponsor’s decision to stop enrollment. The termination entry should not be taken as evidence of a particular statistical finding or clinical interpretation. In general, a registry record is a structured account of study design and posted results; conclusions beyond its documented information require details that are not reported in the registry record.
13. Why This Trial Matters Statistically
Statistically, this trial illustrates the difference between describing observed counts and estimating a comparative effect. The posted information makes the participant counts for serious and other adverse events explicit by cohort. Those counts are useful for understanding what was recorded among participants, while the absence of inferential results means there is no reported estimate of how the groups compare after accounting for uncertainty.
The design also makes cohort completion important to interpretation. Four active-dose cohorts have participants recorded, while the planned 0.021 mg/kg cohort has none. The study therefore does not provide participant-level observations for every listed dose. That boundary matters when interpreting the intended ascending-dose evaluation: the record’s listed dose range and the doses with observed participant data are not the same.
The termination entry highlights why decisions about enrollment and dose escalation need context. The registry states that a DSMB recommendation and sponsor decision led to closure before Cohort 5, but does not report the recommendation’s basis, stopping criteria, or statistical procedures. It is not possible to reconstruct the decision or infer the results that informed it from the posted counts alone.
Finally, the record shows why transparent reporting of analysis plans, missing-data handling, event definitions, and uncertainty estimates is important. These details help readers distinguish descriptive summaries from comparative evidence and assess how precisely results apply to the study participants. Their absence does not erase the posted observations, but it limits the conclusions that can be drawn from them.
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 trial-specific limitations constrain interpretation. Enrollment is recorded as 32, and the group counts are small. A small number of participants gives limited information about uncommon events and makes group summaries sensitive to the experience of individual participants. The record does not report confidence intervals or inferential comparisons for the adverse-event counts.
The fifth planned dose, 0.021 mg/kg, has zero participants recorded. The results therefore contain no enrolled-participant observations for that cohort. The study also terminated after a DSMB recommendation and sponsor decision, and the record states that enrollment closed without proceeding to Cohort 5. The recommendation’s rationale, stopping criteria, and any interim statistical procedures are not reported in the registry record.
The adverse-event summaries do not include event-level descriptions, severity distributions, relatedness assessments, or detailed observation and follow-up information. The registry states a timeframe of 30 Days (+7), but the precise event ascertainment schedule and treatment of incomplete follow-up are not reported in the registry record. Analysis populations and missing-data procedures are also not reported.
The record lists 11 outcome measures but zero analyses. Specific pharmacokinetic results, planned comparisons, model specifications, and multiplicity procedures are not reported in the registry record. These gaps limit evaluation of the full study objectives and the precision, completeness, and comparative interpretation of the posted safety results.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Evaluate the Intramuscular Administration of Scopolamine — NCT04314713.
- Registry record last updated 2025-02-19; status last verified 2025-01.
- Results first posted 2025-02-19.
- 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
NCT04314713 is a Phase 1 randomized, triple-masked, parallel-group, placebo-controlled dose-escalation study of intramuscular Scopolamine Hydrobromide Trihydrate. The registry records enrollment of 32 and identifies Battelle Memorial Institute as sponsor. The recorded study status is terminated.
The active-dose cohorts with participants are 0.005 mg/kg, 0.007 mg/kg, 0.011 mg/kg, and 0.014 mg/kg. The listed 0.021 mg/kg cohort has no participants recorded. The primary outcome concerns participant counts and degree of adverse events over 30 Days (+7). The registry reports zero serious adverse events and zero deaths in the groups, while other adverse-event participant counts vary across the recorded cohorts and placebo group.
The study description includes pharmacokinetics, but specific pharmacokinetic results are not reported in the registry record. The record states that enrollment closed and Cohort 5 would not proceed following a DSMB recommendation and sponsor decision on 13 June 2021. Statistical analyses, analysis populations, missing-data methods, and the detailed basis for that decision are not reported in the registry record.