In short
Clinical trials are studying Alprazolam in different patient groups, including children 12 years and older, adults with prolonged seizures, and women undergoing fertility treatment. These studies mainly look at safety, effectiveness, and treatment success in specific situations.
Key points
- Clinical trials investigating Alprazolam in this data focus on two main areas: long seizures and procedural pain during fertility treatment. Two Phase 3 studies are looking at children 12 years and older and adults with stereotypical prolonged seizure, with outcomes centered on treatment success, seizure recurrence, and safety. Another authorised study includes women undergoing IVF or ART and measures pain during oocyte pick-up. The seizure trials compare Alprazolam with placebo, while the fertility-related study includes Alprazolam among several pain-management options. Overall, the trials are mainly testing whether Alprazolam can help in specific short-term clinical situations and whether it is safe in those settings.
Trial overview
The trial data show three studies that investigate Alprazolam in different settings. Two studies focus on prolonged seizures in children 12 years and older and adults, and one study includes Alprazolam in a pain management plan for oocyte pick-up during fertility treatment.
Studies in prolonged seizures
NCT05076617 is an authorised Phase 3 extension study for children aged 12 years and older and adults with treatment of stereotypical prolonged seizure. Its brief summary says the study is designed to evaluate the long-term safety and tolerability of Staccato Alprazolam.
The main safety outcomes are the frequency of treatment-emergent adverse events, the frequency of adverse events that lead to withdrawal from the study, and the frequency of serious adverse events. In simple terms, this trial is checking whether health problems appear after treatment starts and whether they are serious enough to make people stop the study.
NCT05077904 is another authorised Phase 3 study in the same age group, also focused on stereotypical prolonged seizure. This outpatient study compares a single administration of Staccato Alprazolam with placebo, which is a look-alike treatment with no active substance.
The primary outcome is treatment success for the treated seizure with no recurrence after 2 hours. The brief summary adds that the study looks at whether a single dose can rapidly stop a seizure episode within 90 seconds and prevent seizure return for up to 2 hours after the investigational medicinal product is given.
Study in fertility-related procedural pain
Trial 2025-523018-10-00 is an authorised interventional study about acute procedural pain during oocyte pick-up, also called oocyte retrieval, in women undergoing IVF or ART. The intervention list includes XANAX 0.5 mg tablets, along with several other pain-management medicines used in the study plan.
The primary outcome is overall intra-procedural pain intensity during oocyte pick-up, measured with a VAS pain scale from 0 to 100 mm every 2 minutes from the first puncture until the procedure is finished. The study summary says the research is designed to compare pain control approaches during the procedure.
Who can participate
The seizure studies include children 12 years and older and adults with stereotypical prolonged seizure. These trials are not described as open to all patients with seizures, but to the specific group named in the trial records.
The fertility-related study includes women undergoing IVF or ART who are having oocyte pick-up. This means the study is focused on a procedure-related pain setting rather than on seizure care.
What the trials measure
The seizure extension study measures safety through adverse events, withdrawal from the study, and serious adverse events. These are common trial endpoints, meaning the main results researchers want to track.
The outpatient seizure study measures whether the treated seizure succeeds without coming back within 2 hours. This endpoint combines fast seizure control with lasting effect over a short follow-up period.
The fertility pain study measures pain repeatedly during the procedure using VAS scores every 2 minutes, and the protocol mentions a derived measure such as mean, median, or area under the curve over time. Area under the curve means the study looks at pain across time, not just one single score.
Study design and phases
Both seizure studies are Phase 3 and are described as interventional trials. Phase 3 studies usually test a treatment in a larger group and compare it with another approach such as placebo.
The fertility-related pain study is also interventional and is listed as Low Intervention. In this data, that means the study is still a clinical trial, but the treatment approach is presented as a lower-intensity research setting than a typical drug trial.
The enrollment numbers are 292 for NCT05076617, 350 for NCT05077904, and 318 for 2025-523018-10-00. These numbers show that the studies are designed to include moderate-sized groups of participants.