Trial Outcomes & Findings for Open-label Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Children With Status Epilepticus (Convulsive) in a Healthcare Setting in Japan (NCT NCT03336645)
NCT ID: NCT03336645
Last Updated: 2020-07-31
Results Overview
Response rate was defined as the percentage of participants with therapeutic success. Therapeutic success was defined as the cessation of visible seizure activity within 10 minutes with a sustained absence of visible seizure activity for 30 minutes following a single dose of MHOS/SHP615 without the need for additional rescue medication.
COMPLETED
PHASE3
25 participants
From start of study drug administration up to 30 minutes post-dose
2020-07-31
Participant Flow
The study was conducted at 28 study centers in the Japan between 23 October 2017 (first participant first visit) and 19 August 2019 (last participant last visit).
A total of 25 participants were enrolled, received treatment and completed the study.
Participant milestones
| Measure |
SHP615
Participants received single fixed age-specific dose (3 months to less than \[\<\] 1 year received 2.4 milligram \[mg\]; 1 to \< 5 years received 5 mg; 5 to \<10 years received 7.5 mg and 10 to \< 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
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|---|---|
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Overall Study
STARTED
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25
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Overall Study
COMPLETED
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25
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-label Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Children With Status Epilepticus (Convulsive) in a Healthcare Setting in Japan
Baseline characteristics by cohort
| Measure |
SHP615
n=25 Participants
Participants received single fixed age-specific dose (3 months to less than \[\<\] 1 year received 2.4 milligram \[mg\]; 1 to \< 5 years received 5 mg; 5 to \<10 years received 7.5 mg and 10 to \< 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
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Age, Continuous
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4.63 Years
STANDARD_DEVIATION 4.033 • n=39 Participants
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Sex: Female, Male
Female
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16 Participants
n=39 Participants
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Sex: Female, Male
Male
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9 Participants
n=39 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=39 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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25 Participants
n=39 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=39 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=39 Participants
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Race (NIH/OMB)
Asian
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25 Participants
n=39 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=39 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=39 Participants
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Race (NIH/OMB)
White
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0 Participants
n=39 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=39 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=39 Participants
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PRIMARY outcome
Timeframe: From start of study drug administration up to 30 minutes post-dosePopulation: Full Analysis Set (FAS) consisted of all participants in the safety set who had at least 1 assessment for determination of therapeutic success (date and time of the IP administration and seizure cessation for the initial seizure; participants with no recurrence of seizure within 30 minutes post-dose) performed after the administration of the IP.
Response rate was defined as the percentage of participants with therapeutic success. Therapeutic success was defined as the cessation of visible seizure activity within 10 minutes with a sustained absence of visible seizure activity for 30 minutes following a single dose of MHOS/SHP615 without the need for additional rescue medication.
Outcome measures
| Measure |
SHP615
n=25 Participants
Participants received single fixed age-specific dose (3 months to less than \[\<\] 1 year received 2.4 milligram \[mg\]; 1 to \< 5 years received 5 mg; 5 to \<10 years received 7.5 mg and 10 to \< 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
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Percentage of Participants With Response Rate
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80.0 Percentage of participants
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SECONDARY outcome
Timeframe: From start of study drug administration up to 1, 4 and 6 hours post-dosePopulation: FAS consisted of all participants in the safety set who had at least 1 assessment for determination of therapeutic success (date and time of the IP administration and seizure cessation for the initial seizure; participants with no recurrence of seizure within 30 minutes post-dose) performed after the administration of the IP.
Percentage of participants whose seizure event stopped within 10 minutes of single dose administration of SHP615 and who had sustained absence of seizure activity for at least 1, 4, and 6 hours were reported.
Outcome measures
| Measure |
SHP615
n=25 Participants
Participants received single fixed age-specific dose (3 months to less than \[\<\] 1 year received 2.4 milligram \[mg\]; 1 to \< 5 years received 5 mg; 5 to \<10 years received 7.5 mg and 10 to \< 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
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Percentage of Participants Who Had Sustained Absence of Seizure Activity for at Least 1, 4 and 6 Hours
Sustained Absence for at least 1 hour
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68.0 Percentage of participants
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Percentage of Participants Who Had Sustained Absence of Seizure Activity for at Least 1, 4 and 6 Hours
Sustained Absence for at least 4 hours
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36.0 Percentage of participants
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Percentage of Participants Who Had Sustained Absence of Seizure Activity for at Least 1, 4 and 6 Hours
Sustained Absence for at least 6 hours
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32.0 Percentage of participants
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SECONDARY outcome
Timeframe: From start of study drug administration up to follow-up (Day 8)Population: FAS consisted of all participants in the safety set who had at least 1 assessment for determination of therapeutic success (date and time of the IP administration and seizure cessation for the initial seizure; participants with no recurrence of seizure within 30 minutes post-dose) performed after the administration of the IP.
Time to resolution of seizures (convulsions) was calculated as time from IP administration to the end of the initial seizure or administration of rescue anti-convulsant medication, whichever occurs first. Initial seizure referred to the seizure that triggered the use of the IP. Number of participants with time to resolution of seizures (convulsions) from the administration of SHP615 were reported.
Outcome measures
| Measure |
SHP615
n=25 Participants
Participants received single fixed age-specific dose (3 months to less than \[\<\] 1 year received 2.4 milligram \[mg\]; 1 to \< 5 years received 5 mg; 5 to \<10 years received 7.5 mg and 10 to \< 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
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Number of Participants With Time to Resolution of Seizures (Convulsions)
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21 Participants
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SECONDARY outcome
Timeframe: From start of study drug administration up to follow-up (Day 8)Population: FAS consisted of all participants in the safety set who had at least 1 assessment for determination of therapeutic success (date and time of the IP administration and seizure cessation for the initial seizure; participants with no recurrence of seizure within 30 minutes post-dose) performed after the administration of the IP.
Time to recovery of consciousness (in minutes) was calculated only for participants who lost consciousness pre-dose at time from investigational product administration to recovery of consciousness post-dose or administration of rescue anticonvulsant medication, whichever occurs first. Number of participants with time to recovery of consciousness were reported.
Outcome measures
| Measure |
SHP615
n=25 Participants
Participants received single fixed age-specific dose (3 months to less than \[\<\] 1 year received 2.4 milligram \[mg\]; 1 to \< 5 years received 5 mg; 5 to \<10 years received 7.5 mg and 10 to \< 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
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Number of Participants With Time to Recovery of Consciousness
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19 Participants
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SECONDARY outcome
Timeframe: 10 minutes post-dosePopulation: FAS consisted of all participants in the safety set who had at least 1 assessment for determination of therapeutic success (date and time of the IP administration and seizure cessation for the initial seizure; participants with no recurrence of seizure within 30 minutes post-dose) performed after the administration of the IP.
Percentage of participants who required additional anticonvulsant medication for ongoing SE, 10 minutes after a single dose of SHP615 were reported.
Outcome measures
| Measure |
SHP615
n=25 Participants
Participants received single fixed age-specific dose (3 months to less than \[\<\] 1 year received 2.4 milligram \[mg\]; 1 to \< 5 years received 5 mg; 5 to \<10 years received 7.5 mg and 10 to \< 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
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Percentage of Participants Who Required Additional Anticonvulsant Medication for Ongoing Status Epilepticus (SE)
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16.0 Percentage of Participants
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SECONDARY outcome
Timeframe: 10 minutes post-dosePopulation: FAS consisted of all participants in the safety set who had at least 1 assessment for determination of therapeutic success (date and time of the IP administration and seizure cessation for the initial seizure; participants with no recurrence of seizure within 30 minutes post-dose) performed after the administration of the IP.
Treatment failure/non-responder was defined as participants with continuing seizure activity and/or the need for any additional rescue medication according to the participating healthcare setting protocol or guideline, for 10 mins or more after a single dose of the IP.
Outcome measures
| Measure |
SHP615
n=25 Participants
Participants received single fixed age-specific dose (3 months to less than \[\<\] 1 year received 2.4 milligram \[mg\]; 1 to \< 5 years received 5 mg; 5 to \<10 years received 7.5 mg and 10 to \< 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
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Percentage of Participants Who Failed to Respond to the Treatment With SHP615
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16.0 Percentage of participants
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SECONDARY outcome
Timeframe: 10 minutes post-dosePopulation: Pharmacokinetic (PK) set consisted of all participants who received a single dose of the IP and for whom at least 1 PK blood sample was collected post-dose. Here, the number of participants analyzed refer to the participants evaluable for this outcome.
Concentration of SHP615 in plasma at 10 minutes were reported.
Outcome measures
| Measure |
SHP615
n=16 Participants
Participants received single fixed age-specific dose (3 months to less than \[\<\] 1 year received 2.4 milligram \[mg\]; 1 to \< 5 years received 5 mg; 5 to \<10 years received 7.5 mg and 10 to \< 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
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Concentration of SHP615 in Plasma at 10 Minutes (C10)
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45.2 nanogram per milliliter (ng/mL)
Standard Deviation 21.3
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SECONDARY outcome
Timeframe: 1, 3, 6 hours post-dosePopulation: PK set consisted of all participants who received a single dose of the IP and for whom at least 1 PK blood sample was collected post-dose. Here, the number of participants analyzed refer to the participants evaluable for this outcome.
Cmax of SHP615 in plasma were reported.
Outcome measures
| Measure |
SHP615
n=16 Participants
Participants received single fixed age-specific dose (3 months to less than \[\<\] 1 year received 2.4 milligram \[mg\]; 1 to \< 5 years received 5 mg; 5 to \<10 years received 7.5 mg and 10 to \< 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
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Maximum Plasma Concentration (Cmax) of SHP615
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78.0 ng/mL
Standard Deviation 16.4
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SECONDARY outcome
Timeframe: Pre-dose, 10 minutes post-dosePopulation: PK set consisted of all participants who received a single dose of the IP and for whom at least 1 PK blood sample was collected post-dose. Here, the number of participants analyzed refer to the participants evaluable for this outcome.
AUC0-10 of SHP615 in plasma were reported. Here "min ng/mL" was minutes nanogram per milliliter.
Outcome measures
| Measure |
SHP615
n=16 Participants
Participants received single fixed age-specific dose (3 months to less than \[\<\] 1 year received 2.4 milligram \[mg\]; 1 to \< 5 years received 5 mg; 5 to \<10 years received 7.5 mg and 10 to \< 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
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Area Under the Concentration-time Curve From Time Zero to 10 Minutes (AUC0-10) of SHP615 in Plasma
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304 min ng/mL
Standard Deviation 149
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SECONDARY outcome
Timeframe: Pre-dose, 60 minutes post-dosePopulation: PK set consisted of all participants who received a single dose of the IP and for whom at least 1 PK blood sample was collected post-dose. Here, the number of participants analyzed refer to the participants evaluable for this outcome.
AUC0-60 of SHP615 in plasma were reported.
Outcome measures
| Measure |
SHP615
n=16 Participants
Participants received single fixed age-specific dose (3 months to less than \[\<\] 1 year received 2.4 milligram \[mg\]; 1 to \< 5 years received 5 mg; 5 to \<10 years received 7.5 mg and 10 to \< 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
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Area Under the Concentration-time Curve From Time Zero to 60 Minutes (AUC0-60) of SHP615 in Plasma
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2965 min ng/mL
Standard Deviation 592
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SECONDARY outcome
Timeframe: Pre-dose, 180 minutes post-dosePopulation: PK set consisted of all participants who received a single dose of the IP and for whom at least 1 PK blood sample was collected post-dose. Here, the number of participants analyzed refer to the participants evaluable for this outcome.
AUC0-180 of SHP615 in plasma were reported.
Outcome measures
| Measure |
SHP615
n=16 Participants
Participants received single fixed age-specific dose (3 months to less than \[\<\] 1 year received 2.4 milligram \[mg\]; 1 to \< 5 years received 5 mg; 5 to \<10 years received 7.5 mg and 10 to \< 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
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Area Under the Concentration-time Curve From Time Zero to 180 Minutes (AUC0-180) of SHP615 in Plasma
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4411 min ng/mL
Standard Deviation 1140
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SECONDARY outcome
Timeframe: Pre-dose, 1, 3, and 6 hours post-dosePopulation: PK set consisted of all participants who received a single dose of the IP and for whom at least 1 PK blood sample was collected post-dose. Here, the number of participants analyzed refer to the participants evaluable for this outcome.
AUC(0-infinity) of SHP615 in plasma were reported.
Outcome measures
| Measure |
SHP615
n=16 Participants
Participants received single fixed age-specific dose (3 months to less than \[\<\] 1 year received 2.4 milligram \[mg\]; 1 to \< 5 years received 5 mg; 5 to \<10 years received 7.5 mg and 10 to \< 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
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Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of SHP615 in Plasma
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5847 min ng/mL
Standard Deviation 2599
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SECONDARY outcome
Timeframe: 1, 3, and 6 hours post-dosePopulation: PK set consisted of all participants who received a single dose of the IP and for whom at least 1 PK blood sample was collected post-dose. Here, the number of participants analyzed refer to the participants evaluable for this outcome.
Tmax of SHP615 in plasma were reported.
Outcome measures
| Measure |
SHP615
n=16 Participants
Participants received single fixed age-specific dose (3 months to less than \[\<\] 1 year received 2.4 milligram \[mg\]; 1 to \< 5 years received 5 mg; 5 to \<10 years received 7.5 mg and 10 to \< 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
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Time at Maximum Concentration (Tmax) of SHP615 in Plasma
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20.5 minutes
Interval 15.5 to 28.0
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SECONDARY outcome
Timeframe: 1, 3, and 6 hours post-dosePopulation: PK set consisted of all participants who received a single dose of the IP and for whom at least 1 PK blood sample was collected post-dose. Here, the number of participants analyzed refer to the participants evaluable for this outcome.
T1/2 of SHP615 in plasma were reported.
Outcome measures
| Measure |
SHP615
n=16 Participants
Participants received single fixed age-specific dose (3 months to less than \[\<\] 1 year received 2.4 milligram \[mg\]; 1 to \< 5 years received 5 mg; 5 to \<10 years received 7.5 mg and 10 to \< 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
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Elimination Half-life (T1/2) of SHP615 in Plasma
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115 minutes
Interval 90.6 to 303.0
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SECONDARY outcome
Timeframe: From start of study drug administration up to follow-up (Day 8)Population: Safety set consisted of all participants who had received a single dose of the IP, regardless of whether IP administration was documented to be complete or not on the IP administration page of the eCRF.
Respiratory depression, included the following measures within 24 hours after administration of the IP: i) Persistent decrease in oxygen saturation to \< 92 percent (%) measured at 10, 30 minutes, and 4, 6, and 24 hours post-dose (i.e, \< 92 % on room air for 2 minutes or more after dosing while monitoring \[per healthcare setting protocol and/or the clinical judgment of the physician\]) ii) Increase in respiratory effort such that assisted ventilation is used (bag-valve-mask ventilation or endotracheal intubation). Number of participants with respiratory depression were reported.
Outcome measures
| Measure |
SHP615
n=25 Participants
Participants received single fixed age-specific dose (3 months to less than \[\<\] 1 year received 2.4 milligram \[mg\]; 1 to \< 5 years received 5 mg; 5 to \<10 years received 7.5 mg and 10 to \< 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
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Number of Participants With Respiratory Depression
Persistent Decrease in Oxygen Saturation
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0 Participants
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Number of Participants With Respiratory Depression
Increase in Respiratory Effort
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1 Participants
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SECONDARY outcome
Timeframe: From start of study drug administration up to follow-up (Day 8)Population: Safety set consisted of all participants who had received a single dose of the IP, regardless of whether IP administration was documented to be complete or not on the IP administration page of the eCRF.
TEAEs was defined as AEs that start or deteriorate on or after the date of the first dose of investigational product and no later than 3 days following the last dose of IP. Number of participants with aspiration pneumonia identified as TEAEs were reported.
Outcome measures
| Measure |
SHP615
n=25 Participants
Participants received single fixed age-specific dose (3 months to less than \[\<\] 1 year received 2.4 milligram \[mg\]; 1 to \< 5 years received 5 mg; 5 to \<10 years received 7.5 mg and 10 to \< 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
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Number of Participants With Aspiration Pneumonia Reported as Treatment Emergent Adverse Events (TEAEs)
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0 Participants
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SECONDARY outcome
Timeframe: Baseline, 24 hours post-dosePopulation: Safety set consisted of all participants who had received a single dose of the IP, regardless of whether IP administration was documented to be complete or not on the IP administration page of the eCRF. Here, the number of participants analyzed refer to the participants evaluable for this outcome.
Sedation-Agitation was assessed, using the "Riker Sedation-Agitation Scale" (SAS) by the following 7-point scale: 7. dangerous agitation; 6. very agitated; 5. agitated; 4. calm, cooperative; 3. sedated; 2. very sedated; 1. unarousable. Change from baseline in riker sedation-agition scale at 24 hours post-dose were reported.
Outcome measures
| Measure |
SHP615
n=23 Participants
Participants received single fixed age-specific dose (3 months to less than \[\<\] 1 year received 2.4 milligram \[mg\]; 1 to \< 5 years received 5 mg; 5 to \<10 years received 7.5 mg and 10 to \< 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
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Change From Baseline in Riker Sedation-Agitation Scale at 24 Hours Post-dose
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2.2 Score on the scale
Standard Deviation 1.23
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SECONDARY outcome
Timeframe: From start of study drug administration up to follow-up (Day 8)Population: Safety set consisted of all participants who had received a single dose of the IP, regardless of whether IP administration was documented to be complete or not on the IP administration page of the eCRF.
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs was defined as AEs that start or deteriorate on or after the date of the first dose of investigational product and no later than 3 days following the last dose of IP. Number of participants with TEAEs were reported.
Outcome measures
| Measure |
SHP615
n=25 Participants
Participants received single fixed age-specific dose (3 months to less than \[\<\] 1 year received 2.4 milligram \[mg\]; 1 to \< 5 years received 5 mg; 5 to \<10 years received 7.5 mg and 10 to \< 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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9 Participants
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SECONDARY outcome
Timeframe: Baseline, 24 hours post-dosePopulation: Safety set consisted of all participants who had received a single dose of the IP, regardless of whether IP administration was documented to be complete or not on the IP administration page of the eCRF. Here, the number of participants analyzed refer to the participants evaluable for this outcome.
Oxygen saturation at baseline was measured and recorded on room air. The investigator had recorded the oxygen saturation, oxygen delivery system and amount of oxygen administered during the study. Change from baseline in oxygen saturation percentage at 24 hours post-dose were reported.
Outcome measures
| Measure |
SHP615
n=14 Participants
Participants received single fixed age-specific dose (3 months to less than \[\<\] 1 year received 2.4 milligram \[mg\]; 1 to \< 5 years received 5 mg; 5 to \<10 years received 7.5 mg and 10 to \< 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
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|---|---|
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Change From Baseline in Oxygen Saturation Percentage at 24 Hours Post-dose
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3.7 Percentage of oxygen saturation
Standard Deviation 10.21
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Adverse Events
SHP615
Serious adverse events
| Measure |
SHP615
n=25 participants at risk
Participants received single fixed age-specific dose (3 months to less than \[\<\] 1 year received 2.4 milligram \[mg\]; 1 to \< 5 years received 5 mg; 5 to \<10 years received 7.5 mg and 10 to \< 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
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|---|---|
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Nervous system disorders
Seizure cluster
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4.0%
1/25 • Number of events 1 • From start of study drug administration to follow-up (8 days).
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Nervous system disorders
Status epilepticus
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4.0%
1/25 • Number of events 1 • From start of study drug administration to follow-up (8 days).
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Respiratory, thoracic and mediastinal disorders
Respiratory depression
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4.0%
1/25 • Number of events 1 • From start of study drug administration to follow-up (8 days).
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Other adverse events
| Measure |
SHP615
n=25 participants at risk
Participants received single fixed age-specific dose (3 months to less than \[\<\] 1 year received 2.4 milligram \[mg\]; 1 to \< 5 years received 5 mg; 5 to \<10 years received 7.5 mg and 10 to \< 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS) / SHP615 on Day 1.
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
8.0%
2/25 • Number of events 2 • From start of study drug administration to follow-up (8 days).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER