Trial Outcomes & Findings for A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting (NCT NCT05059600)
NCT ID: NCT05059600
Last Updated: 2025-09-15
Results Overview
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as an AE with onset after the start of investigational product, or any worsening of a preexisting medical condition/AE with onset after the start of investigational product and throughout the study. Percentages are rounded off to the nearest single decimal.
COMPLETED
PHASE4
52 participants
Up to Day 3
2025-09-15
Participant Flow
Participants were enrolled at 5 active clinical sites in the United States from 08 October 2021 to 14 July 2022.
A total of 80 participants were screened, of which 52 were enrolled and 42 were treated.
Participant milestones
| Measure |
ZULRESSO®
Participants received a 60-hour single continuous intravenous (IV) infusion of ZULRESSO®, at 30 micrograms per kilogram per hour (mcg/kg/hour) (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a dose taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during the study.
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|---|---|
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Overall Study
STARTED
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52
|
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Overall Study
Treated
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42
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Overall Study
COMPLETED
|
42
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Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
ZULRESSO®
Participants received a 60-hour single continuous intravenous (IV) infusion of ZULRESSO®, at 30 micrograms per kilogram per hour (mcg/kg/hour) (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a dose taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during the study.
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|---|---|
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Overall Study
Enrolled but not Treated
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10
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Baseline Characteristics
A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting
Baseline characteristics by cohort
| Measure |
ZULRESSO®
n=42 Participants
Participants received a 60-hour single continuous IV infusion of ZULRESSO®, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a dose taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during the study.
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|---|---|
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Age, Continuous
|
31.9 years
STANDARD_DEVIATION 5.76 • n=5 Participants
|
|
Sex: Female, Male
Female
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42 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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24 Participants
n=5 Participants
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|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
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Race/Ethnicity, Customized
White
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33 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Black or African American
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6 Participants
n=5 Participants
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|
Race/Ethnicity, Customized
Asian
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1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Not Specified
|
1 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to Day 3Population: Safety Set included all participants who were administered ZULRESSO®.
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as an AE with onset after the start of investigational product, or any worsening of a preexisting medical condition/AE with onset after the start of investigational product and throughout the study. Percentages are rounded off to the nearest single decimal.
Outcome measures
| Measure |
ZULRESSO®
n=42 Participants
Participants received a 60-hour single continuous IV infusion of ZULRESSO®, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during the study.
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|---|---|
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Percentage of Participants With At Least One Treatment-Emergent Adverse Event (TEAE) Leading to Dose Interruption/Discontinuation
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7.1 percentage of participants
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SECONDARY outcome
Timeframe: Up to Day 3Population: Safety Set included all participants who were administered ZULRESSO®.
Nonadherence was defined by failure of any of following: * Home infusion provider to train all pharmacy and home healthcare providers (HHPs) in dispensing/administration of ZULRESSO® on risk of excessive sedation/loss of consciousness * HHPs to counsel participants on risk of excessive sedation/loss of consciousness * Deliver ZULRESSO® per protocol * Provide preprogrammed peristaltic pump * HHP:assess excessive sedation every 2 hours in planned nonsleep periods, change infusion bag per protocol, at least one HHP available in participant's home for the duration of infusion * Fall protocol in place * Monitor participants with pulse oximeter * Stop infusion when participant is primary caregiver of dependents and/or identification of excessive sedation/loss of consciousness/hypoxic episode * Caution participants post-infusion against engaging in hazardous activities requiring mental alertness * Complete AE of special interest/Serious AE form * Infusion resumed after hypoxia episode
Outcome measures
| Measure |
ZULRESSO®
n=42 Participants
Participants received a 60-hour single continuous IV infusion of ZULRESSO®, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during the study.
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|---|---|
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Percentage of Participants With Nonadherence With the Safe-Use Conditions for Administration of ZULRESSO®
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76.19 percentage of participants
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SECONDARY outcome
Timeframe: Up to Day 3Population: Safety Set included all participants who were administered ZULRESSO®. Overall number of units analyzed signifies total number of use related issues.
Home healthcare provider (HHP) staff completed checklists at end of each day and/or shift to document any use-related issues throughout duration of infusion. Any use-related issues determined to be critical in nature were followed up immediately and were reported adequately. Use-related issues were categorized as Critical Use Error (UE): HHP failed to complete a task or made uncorrected use error during task that could have resulted in harm, compromised medical care, incidence of nonadherence with safe use conditions for administration of ZULRESSO, or incidence of use-related issues related to home administration of ZULRESSO; Use Difficulty (UD): HHP successfully completed a task but did so while experiencing issues/operational difficulties; Close Call (CC): HHP committed error that could have led to a task failure, but self-corrected and completed task successfully. Multiple occurrences of issue throughout a single infusion was included only once in total.
Outcome measures
| Measure |
ZULRESSO®
n=75 Issues
Participants received a 60-hour single continuous IV infusion of ZULRESSO®, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during the study.
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|---|---|
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Number of Use-Related Issues Related to the Home Administration of ZULRESSO®
Critical Use Errors (UE)
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13 Issues
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Number of Use-Related Issues Related to the Home Administration of ZULRESSO®
Use Difficulties (UD)
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62 Issues
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Number of Use-Related Issues Related to the Home Administration of ZULRESSO®
Close Calls (CC)
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0 Issues
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SECONDARY outcome
Timeframe: Up to Day 3Population: Safety Set included all participants who were administered ZULRESSO®.
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. TEAE was defined as an AE with onset after the start of investigational product, or any worsening of a preexisting medical condition/AE with onset after the start of investigational product and throughout the study. Percentages are rounded off to nearest single decimal.
Outcome measures
| Measure |
ZULRESSO®
n=42 Participants
Participants received a 60-hour single continuous IV infusion of ZULRESSO®, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during the study.
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|---|---|
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Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
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42.9 percentage of participants
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SECONDARY outcome
Timeframe: At screening and during the study (Up to Day 3)Population: Safety Set included all participants who were administered ZULRESSO®.
Medication error was any preventable event that may cause or lead to inappropriate medication use or participant harm while the medication was in the control of the healthcare professional, participant, or consumer. Percentages are rounded off to the nearest single decimal.
Outcome measures
| Measure |
ZULRESSO®
n=42 Participants
Participants received a 60-hour single continuous IV infusion of ZULRESSO®, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during the study.
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|---|---|
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Percentage of Participants With Medication Error
At Screening
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28.6 percentage of participants
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Percentage of Participants With Medication Error
During the Study (Up to Day 3)
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54.8 percentage of participants
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Adverse Events
ZULRESSO®
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ZULRESSO®
n=42 participants at risk
Participants received a 60-hour single continuous IV infusion of ZULRESSO®, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during the study.
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|---|---|
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General disorders
Fatigue
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11.9%
5/42 • Up to Day 3
Safety Set included all participants who were administered ZULRESSO®.
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General disorders
Infusion site pain
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7.1%
3/42 • Up to Day 3
Safety Set included all participants who were administered ZULRESSO®.
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Nervous system disorders
Headache
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9.5%
4/42 • Up to Day 3
Safety Set included all participants who were administered ZULRESSO®.
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Nervous system disorders
Somnolence
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7.1%
3/42 • Up to Day 3
Safety Set included all participants who were administered ZULRESSO®.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI can either be a party and subject to the same restrictions as the institution, or if not a party, the restrictions are described on the face of the contract (i.e., PI is a contractor of the institution; PI is part of a larger group of study personnel; institution has contracted with or otherwise bound all study personnel under confidentiality obligations and requirements to vest intellectual property to the institution).
- Publication restrictions are in place
Restriction type: OTHER