Staccato Alprazolam for Rapid Onset

Overseen By UCB Cares

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: UCB Biopharma SRL

Disqualifiers: Chronic alcohol, Drug abuse, Epilepsy, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day per intervention period

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how quickly a new form of alprazolam, called Staccato alprazolam, starts working compared to midazolam. Researchers aim to determine which treatment acts faster by monitoring changes in brain activity. Participants will receive different treatments, including Staccato alprazolam, nasal diazepam, and intravenous midazolam, to compare results. The trial seeks healthy individuals without major health issues or a history of seizures who are interested in understanding how these medications work. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the unique opportunity to be among the first to receive this new form of alprazolam.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Staccato Alprazolam was well-tolerated in previous studies. One study found that doses of 1.0 mg and 2.0 mg effectively stopped seizures quickly and were generally safe for patients. Common side effects included sleepiness, dizziness, and tiredness, particularly in smokers.

Intravenous Midazolam effectively controls seizures but can sometimes cause low blood pressure and a fast heart rate, especially when administered quickly. Monitoring for these effects during use is important.

Nasal Diazepam also maintains a good safety record. Studies report that it is easy to use and acts quickly, with safety similar to other forms of diazepam. Most patients did not experience serious side effects.

These findings indicate that all three treatments in the trial have been tested before and have known safety profiles. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Staccato Alprazolam because it offers a rapid onset of action for managing acute anxiety or panic attacks. Unlike traditional oral treatments like diazepam and midazolam, which can take longer to work, Staccato Alprazolam is delivered through an inhalation device, allowing the medication to enter the bloodstream quickly and provide fast relief. This unique delivery method could be a game-changer for patients needing immediate anxiety relief, making it a promising alternative to current standard treatments.

What evidence suggests that this trial's treatments could be effective?

Research has shown that Staccato alprazolam, a treatment in this trial, stops seizures quickly, often within minutes, due to its rapid absorption into the body. Another treatment option, intravenous midazolam, is recognized for its quick and effective calming effect, commonly used in hospitals for its reliable and fast action. Nasal diazepam, also under study in this trial, has effectively stopped seizure clusters, sometimes in just a couple of minutes. Each treatment acts swiftly, making them promising for fast relief. ^{1 6 7 8 9}

Who Is on the Research Team?

UCB Cares

Principal Investigator

001 844 599 2273

Are You a Good Fit for This Trial?

This trial is for healthy individuals who can participate in a study to compare the onset time of three different sedative drugs. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.

Inclusion Criteria

I am between 20 and 55 years old.

I am generally healthy as confirmed by recent medical exams and tests.

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

I do not have major health issues that could affect drug processing or pose risks with the study treatment.

Participant has a history of chronic alcohol or drug abuse within 6 months prior to the Screening Visit

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single doses of Staccato Alprazolam, IV Midazolam, or Nasal Diazepam in a crossover design to assess time to onset of action

1 day per intervention period

Multiple visits for each intervention period

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of treatment-emergent adverse events

up to 55 days

What Are the Treatments Tested in This Trial?

Interventions

• Diazepam
• Midazolam
• Staccato Alprazolam

Trial Overview The study is testing how quickly Staccato Alprazolam works compared to intravenous Midazolam and Diazepam by measuring changes in brain activity through qEEG. Participants will receive these sedatives, and their brain waves will be monitored to see which drug acts fastest.

How Is the Trial Designed?

Group I: Pilot Part Experimental Treatment 1 Intervention

Study participants who successfully completed the Screening Period will receive single dose of Intravenous (IV) midazolam on Day 1 of the Intervention Period.

Group II: Main Part-Group 2: Treatment Sequence CA Experimental Treatment 2 Interventions

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.

Group III: Main Part-Group 2: Treatment Sequence AC Experimental Treatment 2 Interventions

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.

Group IV: Main Part-Group 1: Treatment Sequence BA Experimental Treatment 2 Interventions

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.

Group V: Main Part-Group 1: Treatment Sequence AB Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

UCB Biopharma SRL

Lead Sponsor

Trials

118

Recruited

23,200+

Jean-Christophe Tellier

UCB Biopharma SRL

Chief Executive Officer since 2015

MD from University of Reims Champagne-Ardenne, Rheumatology specialization from University of Paris V, Executive business programs at Harvard and INSEAD

Dr. Iris Loew-Friedrich

UCB Biopharma SRL

Chief Medical Officer since 2014

MD from University of Leuven, PhD in Medical Sciences from University of Leuven

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK537321/

Midazolam - StatPearls - NCBI Bookshelf - NIH Intramuscular administration has a bioavailability greater than 90%, with peak plasma concentration (Tmax) typically reached within 30 minutes.

2. annemergmed.com annemergmed.com/article/S0196-0644(22)00363-8/fulltext

Real-World Midazolam Use and Outcomes With Out-of- ... Our findings suggest that the intranasal administration of midazolam is less effective and the intravenous administration of midazolam more ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0964339725000060

Comparative risks and clinical outcomes of midazolam ... In terms of efficacy, midazolam significantly prolonged the time up to extubation and attributed to a longer ICU length of stay. Our subgroup analyses of the ...

4. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2018/209566Orig1s000SumR.pdf

209566Orig1s000 - accessdata.fda.gov Overall, the benefit-risk assessment for IM midazolam favors the benefit of the rapid onset and reliable delivery of efficacy for the treatment ...

5. tp.amegroups.org tp.amegroups.org/article/view/103928/html

Efficacy of premedication with intravenous midazolam on ... Results: Children premedicated with 0.05 mg/kg midazolam achieved a sedated state more rapidly than those who received 0.03 mg/kg midazolam (5.9±2.3 vs. 7.0±3.9 ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/211844s005lbl.pdf

midazolam injection - accessdata.fda.gov Severe hypotension and seizures have been reported following rapid intravenous administration, particularly, with concomitant use of fentanyl. Animal Data.

7. chemm.hhs.gov chemm.hhs.gov/countermeasure_midazolam.htm

Midazolam - Medical Countermeasures Database CONCLUSIONS: For subjects in status epilepticus, intramuscular midazolam is at least as safe and effective as intravenous lorazepam for prehospital seizure ...

8. labeling.pfizer.com labeling.pfizer.com/ShowLabeling.aspx?id=4526

Midazolam Injection, USP Neonates: Midazolam should not be administered by rapid injection in the neonatal population. Severe hypotension and seizures have been reported following rapid ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0753332219305955

Midazolam: Safety of use in palliative care: A systematic ... Owing to its lipophilicity, its onset of action is rapid (1.5–15 minutes) following a single dose administered intravenously (i.v.) or intramuscularly (i.m.).