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Alprazolam

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.

Table of contents

Trial overview

The trial data show three studies that investigate Alprazolam in different settings.[1][2][3] 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.[1][2][3]

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.[1] Its brief summary says the study is designed to evaluate the long-term safety and tolerability of Staccato Alprazolam.[1]

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.[1] 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.[1]

NCT05077904 is another authorised Phase 3 study in the same age group, also focused on stereotypical prolonged seizure.[2] This outpatient study compares a single administration of Staccato Alprazolam with placebo, which is a look-alike treatment with no active substance.[2]

The primary outcome is treatment success for the treated seizure with no recurrence after 2 hours.[2] 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.[2]

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.[3] The intervention list includes XANAX 0.5 mg tablets, along with several other pain-management medicines used in the study plan.[3]

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.[3] The study summary says the research is designed to compare pain control approaches during the procedure.[3]

Who can participate

The seizure studies include children 12 years and older and adults with stereotypical prolonged seizure.[1][2] These trials are not described as open to all patients with seizures, but to the specific group named in the trial records.[1][2]

The fertility-related study includes women undergoing IVF or ART who are having oocyte pick-up.[3] This means the study is focused on a procedure-related pain setting rather than on seizure care.[3]

What the trials measure

The seizure extension study measures safety through adverse events, withdrawal from the study, and serious adverse events.[1] These are common trial endpoints, meaning the main results researchers want to track.[1]

The outpatient seizure study measures whether the treated seizure succeeds without coming back within 2 hours.[2] This endpoint combines fast seizure control with lasting effect over a short follow-up period.[2]

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.[3] Area under the curve means the study looks at pain across time, not just one single score.[3]

Study design and phases

Both seizure studies are Phase 3 and are described as interventional trials.[1][2] Phase 3 studies usually test a treatment in a larger group and compare it with another approach such as placebo.[1][2]

The fertility-related pain study is also interventional and is listed as Low Intervention.[3] 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.[3]

The enrollment numbers are 292 for NCT05076617, 350 for NCT05077904, and 318 for 2025-523018-10-00.[1][2][3] These numbers show that the studies are designed to include moderate-sized groups of participants.[1][2][3]

Trial ID Phase Condition studied Status Enrollment
NCT05076617 Phase 3 Treatment of stereotypical prolonged seizure Authorised 292
NCT05077904 Phase 3 Stereotypical prolonged seizure Authorised 350
2025-523018-10-00 Low Intervention Acute procedural pain associated with oocyte pick-up in women undergoing IVF/ART Authorised 318

FAQ

  • What clinical trials are studying Alprazolam? The trials in this data study Alprazolam for long seizures in children 12 years and older and adults. One trial also includes Alprazolam in a pain management study during oocyte pick-up in fertility treatment.
  • Who can take part in Alprazolam trials? One group includes children 12 years and older and adults with stereotypical prolonged seizure. Another study includes women undergoing IVF or ART for oocyte retrieval.
  • What phase are the Alprazolam trials in? The seizure studies are Phase 3 trials. The fertility-related pain study is listed as a Low Intervention study.
  • What are the trials trying to find out? The trials are checking whether Alprazolam is safe and whether it works well in the studied setting. They also measure how often side effects happen and whether treatment prevents seizure return or reduces pain.
  • What outcomes are measured in these trials? For the seizure studies, outcomes include treatment success, seizure recurrence, and safety events such as adverse events and serious adverse events. For the pain study, the main outcome is pain intensity during the procedure.

Ongoing Clinical Trials on Alprazolam

  • Study on the Safety and Effectiveness of Alprazolam for Treating Long Seizures in Patients Aged 12 and Older

    Recruiting

    3 1
    Investigated drugs:
    Bulgaria Czechia France Germany Hungary Italy +2

  • Study on the Safety of Alprazolam for Treating Long Seizures in Patients Aged 12 and Older

    Recruiting

    3 1
    Investigated drugs:
    Bulgaria Czechia Germany Hungary Italy Poland +1

  • Study of sufentanil versus midazolam for pain relief during egg retrieval in women undergoing fertility treatment

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

Glossary

  • Clinical trial: A research study in people that checks whether a treatment is safe, works well, or both.
  • Phase 3: A later-stage trial that usually compares a treatment with placebo or standard care in a larger group of people.
  • Interventional study: A study where participants receive a treatment or procedure so researchers can measure its effects.
  • Placebo: A look-alike treatment with no active substance. It helps researchers compare results fairly.
  • Stereotypical prolonged seizure: A seizure episode that lasts longer than expected and follows a similar pattern each time.
  • Treatment-emergent adverse events: Health problems that start or get worse after treatment begins.
  • Serious adverse events: Severe medical problems that may need hospital care or cause major harm.
  • Withdrawal from study: When a participant stops taking part in the trial, often because of side effects or other reasons.
  • Treatment success: The main result the researchers want to see, such as stopping a seizure and keeping it from coming back.
  • VAS: A pain scale, usually from 0 to 100, where higher numbers mean more pain.

References