NCT05324852

AGItated Patients Management: intraNASAL Midazolam vs Intramuscular Loxapine

AGItated Patients Management: intraNASAL Midazolam vs Intramuscular Loxapine, a Randomized Non Inferiority Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study is a non-inferiority phase III randomized trial evaluating the effect of intranasal midazolam versus intramuscular loxapine on the rapid tranquilization of agitated patient in emergency department. Intranasal midazolam is safe and may allow a management of extreme agitation state and prevent adverse effects.

Detailed description

This study is a prospective, multicenter, open-label randomized, controlled, parallel-group 2-arm phase III non-inferiority trial. Patients with agitation at emergency department will be randomized to two arms of treatment: one experimental arm with intranasal midazolam 5mg (investigational medicinal product), and one control arm with comparator treatment intramuscular loxapine 100mg. The duration of participation for each patient is at least 28 days (+7 days if follow-up not completed on D28). An endpoint Adjudication Committee will be scheduled.

Conditions

• Emergence Delirium

Interventions

Type	Name	Description
DRUG	Intranasal midazolam	Midazolam, 5 mg, injectable solution in 5mg/ml, intranasal administration, atomize into nose with Mucosal Atomizer Device (MAD) 5mg(1ml) up each nostril , one time
DRUG	Intramuscular loxapine	Loxapine, 100mg, injectable solution in 50mg/2ml intramuscular, intra muscular administration, one time

Timeline

• Start date: 2023-04-09
• Primary completion: 2023-04-09
• Completion: 2024-04-23
• First posted: 2022-04-12
• Last updated: 2024-05-28

Locations

1 site across 1 country: France