Inhaled alprazolam race: can it beat IV sedatives?
NCT ID NCT07020988
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed phase 1 study tested how quickly an inhaled form of alprazolam (Staccato) affects brain activity compared to intravenous midazolam and nasal diazepam. Fifty-five healthy adults received single doses of each drug in a crossover design. Researchers used EEG brain wave monitoring to measure the time to onset of action. The goal is to see if this inhaled approach could provide a fast, needle-free option for conditions like seizures.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Staccato alprazolam (inhaled), midazolam (intravenous), diazepam (nasal)
- What this could lead to
- If successful, this study could show that inhaled alprazolam works as fast as IV sedatives, potentially offering a needle-free option for rapid seizure control.
- What could go wrong
- This is a very early phase 1 study in only 55 healthy people, not patients. It measures brain wave changes, not real-world seizure stopping. The results may not translate to actual treatment benefits.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
55 people
The number who actually took part.
- Started
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Jun 2025
- Finished
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Jan 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
20 to 55 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Up0127 1001
Glendale, California, 91206, United States
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