Healthy ParticipantsPhase 1NCT07020988
A Study to Assess the Time to Onset of Action of Staccato Alprazolam Versus Midazolam and Diazepam in Healthy Participants
A Phase 1 study testing Staccato Alprazolam, Midazolam and Diazepam in people with Healthy Participants, run by UCB Biopharma SRL at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Staccato Alprazolam, Midazolam and Diazepam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2025to 21 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be 20 years to 55 years of age, inclusive, at the time of signing the ICF.
- Participant is overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring, at the Screening Visit and on Day -1 of the single Intervention Period for the Pilot Part or on Day -1 of the first Intervention Period for the Main Part of the study.
- Participant has a bodyweight of at least 45 kilograms (kg) (female) and 50 kg (male) and a body mass index within the range of 18 Kilograms per meter square (Kg/m2) to 30 kg/m2 (inclusive)
- Participant has given informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in protocol.
Who cannot join
- Participant has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the participant's ability to participate in this study.
- Participant has a history of chronic alcohol or drug abuse, as defined in the most recent version of the Diagnostic and Statistical Manual of Mental Disorders, within 6 months prior to the Screening Visit.
- Participant has a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, cerebrovascular, or other major disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
- Participant has a history of or has been diagnosed with epilepsy or epileptic seizures.
- Participant has abnormal EEG findings at Screening including background slowing (<8Hz), focal slowing (focal δ-activity), or epileptiform discharges.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Single Dose, Randomized, Active Comparator, Quantitative Electroencephalogram Crossover Study to Assess the Time to Onset of Action of Staccato Alprazolam Versus Intravenous Midazolam and of Staccato Alprazolam Versus Nasal Diazepam in Healthy Study Participants
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).
- Conditions
- Healthy Participants
- Being tested
- Staccato Alprazolam, Midazolam, Diazepam
- Keywords
- Phase 1, Staccato alprazolam, midazolam, diazepam, Healthy Study Participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staccato AlprazolamDrug
Also called UCB7538
Study participants will receive single dose of Staccato Alprazolam at pre-specified time points.
MidazolamDrug
Study participants will receive single dose of IV Midazolam at pre-specified time points.
DiazepamDrug
Study participants will receive single dose of Nasal Diazepam by inhalation at pre-specified time points.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Midazolam |
| 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. Receives: Drug: Staccato Alprazolam; Drug: Midazolam |
| 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. Receives: Drug: Staccato Alprazolam; Drug: Midazolam |
| 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. Receives: Drug: Staccato Alprazolam; Drug: Diazepam |
| Main Part-Group 2: Treatment Sequence CA | Experimental | 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. Receives: Drug: Staccato Alprazolam; Drug: Diazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within the first 60 minutes of the study intervention administration on Day 1 of the Intervention Period in Group 1
Secondary outcomes (13)
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.
Measured: From the first study intervention administration to the Safety Follow-Up (SFU) Visit/ Early Termination Visit (ETV) (up to 55 Days)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start12 Jun 2025
- Primary completion6 Jan 2026
- Study completion21 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020988
- Sponsor's protocol ID
- UP0127
- Status last verified
- Feb 2026
- First submitted
- 5 Jun 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Dose, Randomized, Active Comparator, Quantitative Electroencephalogram Crossover Study to Assess the Time to Onset of Action of Staccato Alprazolam Versus Intravenous Midazolam and of Staccato Alprazolam Versus Nasal Diazepam in Healthy Study Participants
- ClinicalTrials.gov ID
- NCT07020988
- Acronym / sponsor ID
- UP0127
- Conditions
- Healthy Participants
- Keywords
- Phase 1, Staccato alprazolam, midazolam, diazepam, Healthy Study Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 6 Jan 2026 (actual)
- Study completion
- 21 Jan 2026 (actual)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pilot Part | Experimental | Drug: MidazolamStudy participants who successfully completed the Screening Period will receive single dose of Intravenous (IV) midazolam on Day 1 of the Intervention Period. |
| Main Part-Group 1: Treatment Sequence AB | Experimental | Drug: Staccato Alprazolam, Drug: MidazolamStudy 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. |
| Main Part-Group 1: Treatment Sequence BA | Experimental | Drug: Staccato Alprazolam, Drug: MidazolamStudy 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. |
| Main Part-Group 2: Treatment Sequence AC | Experimental | Drug: Staccato Alprazolam, Drug: DiazepamStudy 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. |
| Main Part-Group 2: Treatment Sequence CA | Experimental | Drug: Staccato Alprazolam, Drug: DiazepamStudy 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. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participant must be 20 years to 55 years of age, inclusive, at the time of signing the ICF.
- Participant is overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring, at the Screening Visit and on Day -1 of the single Intervention Period for the Pilot Part or on Day -1 of the first Intervention Period for the Main Part of the study.
- Participant has a bodyweight of at least 45 kilograms (kg) (female) and 50 kg (male) and a body mass index within the range of 18 Kilograms per meter square (Kg/m2) to 30 kg/m2 (inclusive)
- Participant has given informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in protocol.
Key exclusion criteria (5 listed)
- Participant has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the participant's ability to participate in this study.
- Participant has a history of chronic alcohol or drug abuse, as defined in the most recent version of the Diagnostic and Statistical Manual of Mental Disorders, within 6 months prior to the Screening Visit.
- Participant has a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, cerebrovascular, or other major disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
- Participant has a history of or has been diagnosed with epilepsy or epileptic seizures.
- Participant has abnormal EEG findings at Screening including background slowing (<8Hz), focal slowing (focal δ-activity), or epileptiform discharges.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Staccato AlprazolamAlso: UCB7538Study participants will receive single dose of Staccato Alprazolam at pre-specified time points. | Drug | Main Part-Group 1: Treatment Sequence AB, Main Part-Group 1: Treatment Sequence BA, Main Part-Group 2: Treatment Sequence AC, Main Part-Group 2: Treatment Sequence CA |
| MidazolamStudy participants will receive single dose of IV Midazolam at pre-specified time points. | Drug | Main Part-Group 1: Treatment Sequence AB, Main Part-Group 1: Treatment Sequence BA, Pilot Part |
| DiazepamStudy participants will receive single dose of Nasal Diazepam by inhalation at pre-specified time points. | Drug | Main Part-Group 2: Treatment Sequence AC, Main Part-Group 2: Treatment Sequence CA |
Primary outcome
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 frame: 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 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.
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 frame: 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 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.
13 secondary outcomes
Occurrence of Treatment Emergent Adverse Events (TEAEs) from the first study intervention administration to the Safety Follow-Up (SFU) Visit/ Early Termination Visit (ETV)
Time frame: From the first study intervention administration to the Safety Follow-Up (SFU) Visit/ Early Termination Visit (ETV) (up to 55 Days)
Occurrence of Serious TEAEs from the first study intervention administration to the Safety Follow-Up (SFU) Visit/ Early Termination Visit (ETV)
Time frame: 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 frame: 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 frame: 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
Time frame: 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
Time frame: 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
Time frame: Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose
Maximum concentration (Cmax) of midazolam
Time frame: 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
Time frame: 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
Time frame: Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose
Maximum concentration (Cmax) of diazepam
Time frame: 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
Time frame: 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
Time frame: Plasma samples will be collected at predose (Day 1) and at pre-defined time points upto 24 hours postdose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Healthy Participants
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
001 844 599 2273
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Staccato Alprazolam, Midazolam and Diazepam in people with Healthy Participants, run by UCB Biopharma SRL at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 frame: Within the first 60 minutes of the study intervention administration on Day 1 of the Intervention Period in Group 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.