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The purpose of this study is to estimate the difference in the time to onset of action between Staccato alprazolam and intravenous (iv) midazolam using changes in power in the combined spindle and β1 frequency bands in the qEEG (quantitative electroencephalogram).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilot Part | Experimental | Study participants who successfully completed the Screening Period will receive single dose of Intravenous (IV) midazolam on Day 1 of the Intervention Period. |
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| Main Part-Group 1: Treatment Sequence AB | Experimental | Study participants randomized in Group 1 will receive Treatment A: Staccato Alprazolam on Day 1 of the Intervention Period 1 followed by Treatment B: IV Midazolam on Day 1 of the Intervention Period 2. |
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| Main Part-Group 1: Treatment Sequence BA | Experimental | Study participants randomized in Group 1 will receive Treatment B: IV Midazolam on Day 1 of the Intervention Period 1 followed by Treatment A: Staccato Alprazolam on Day 1 of the Intervention Period 2. |
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| Main Part-Group 2: Treatment Sequence AC | Experimental | Study participants randomized in Group 2 will receive Treatment A: Staccato Alprazolam on Day 1 of the Intervention Period 1 followed by Treatment C: Nasal Diazepam on Day 1 of the Intervention Period 2. |
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| Main Part-Group 2: Treatment Sequence CA |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Staccato Alprazolam | Drug | Study participants will receive single dose of Staccato Alprazolam at pre-specified time points. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to reach a z-score of absolute power >2 and maintained for at least 60 seconds in the combined spindle and β1 frequency bands within the first 60 minutes of study intervention administration of Staccato alprazolam in Group 1 | Time to reach a z-score of absolute power >2 is derived from the z-scores over time for the combined spindle and β1 frequency bands. The z-scores are calculated using an algorithm applied to the quantitative electroencephalogram (qEEG) data recorded for each study participant. | Within the first 60 minutes of the study intervention administration on Day 1 of the Intervention Period in Group 1 |
| Time to reach a z-score of absolute power >2 and maintained for at least 60 seconds in the combined spindle and β1 frequency bands within the first 60 minutes of study intervention administration of iv midazolam in Group 1 | Time to reach a z-score of absolute power >2 is derived from the z-scores over time for the combined spindle and β1 frequency bands. The z-scores are calculated using an algorithm applied to the quantitative electroencephalogram (qEEG) data recorded for each study participant. | Within the first 60 minutes of the study intervention administration on Day 1 of the Intervention Period in Group 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Treatment Emergent Adverse Events (TEAEs) from the first study intervention administration to the Safety Follow-Up (SFU) Visit/ Early Termination Visit (ETV) | Treatment Emergent Adverse Events (TEAEs) are any untoward medical incidence in a participant after the administration of study treatment, whether or not these events are related to study treatment. | From the first study intervention administration to the Safety Follow-Up (SFU) Visit/ Early Termination Visit (ETV) (up to 55 Days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Up0127 1001 | Glendale | California | 91206 | United States |
Due to the small sample size in this trial, individual patient-level data (IPD) cannot be adequately anonymized as, there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D003975 | Diazepam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Study participants randomized in Group 2 will receive Treatment C: Nasal Diazepam on Day 1 of the Intervention Period 1 followed by Treatment A: Staccato Alprazolam on Day 1 of the Intervention Period 2. |
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| Midazolam | Drug | Study participants will receive single dose of IV Midazolam at pre-specified time points. |
|
| Diazepam | Drug | Study participants will receive single dose of Nasal Diazepam by inhalation at pre-specified time points. |
|
| Occurrence of Serious TEAEs from the first study intervention administration to the Safety Follow-Up (SFU) Visit/ Early Termination Visit (ETV) | Serious Treatment-Emergent Adverse Events (Serious TEAEs) are any untoward medical incidence in a participant during administered study treatment, whether or not these events are related to study treatment and additionally are emergent untoward medical occurrence that at any dose: Results in death; Is life-threatening; Requires in patient hospitalisation or prolongation of existing hospitalisation; Results in persistent disability/incapacity; Is a congenital anomaly or birth defect; Important medical events. | From the first study intervention administration to the Safety Follow-Up (SFU) Visit/ Early Termination Visit (ETV) (up to 55 Days) |
| Time to reach a z-score of absolute power >2 and maintained for at least 60 seconds in the combined spindle and β1 frequency bands within the first 60 Minutes of study intervention administration of Staccato alprazolam in Group 2 | Time to reach a z-score of absolute power >2 is derived from the z-scores over time for the combined spindle and β1 frequency bands. The z-scores are calculated using an algorithm applied to the qEEG data recorded for each study participant. | Within the first 60 minutes of the study intervention administration on Day 1 of the Intervention Period in Group 2 |
| Time to reach a z-score of absolute power >2 and maintained for at least 60 seconds in the combined spindle and β1 frequency bands within the first 60 Minutes of study intervention administration of nasal diazepam in Group 2 | Time to reach a z-score of absolute power >2 is derived from the z-scores over time for the combined spindle and β1 frequency bands. The z-scores are calculated using an algorithm applied to the qEEG data recorded for each study participant. | Within the first 60 minutes of the study intervention administration on Day 1 of the Intervention Period in Group 2 |
| Maximum concentration (Cmax) of alprazolam | Cmax=maximum concentration | Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose |
| Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC[0-t]) of alprazolam | AUC(0-t)=area under the concentration-time curve from time 0 to the last quantifiable concentration | Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose |
| Area Under the Concentration Time Curve From Time 0 to Infinity (AUC) of alprazolam | AUC=area under the concentration-time curve from time 0 to infinity | Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose |
| Maximum concentration (Cmax) of midazolam | Cmax=maximum concentration | Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose |
| Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC[0-t]) of midazolam | AUC(0-t)=area under the concentration-time curve from time 0 to the last quantifiable concentration | Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose |
| Area Under the Concentration Time Curve From Time 0 to Infinity (AUC) of midazolam | AUC=area under the concentration-time curve from time 0 to infinity | Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose |
| Maximum concentration (Cmax) of diazepam | Cmax=maximum concentration | Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose |
| Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC[0-t]) of diazepam | AUC(0-t)=area under the concentration-time curve from time 0 to the last quantifiable concentration | Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose |
| Area Under the Concentration Time Curve From Time 0 to Infinity (AUC) of diazepam | AUC=area under the concentration-time curve from time 0 to infinity | Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose |
| D006571 | Heterocyclic Compounds |
| D001570 | Benzodiazepinones |