AGItated Patients Management: intraNASAL Midazolam vs Intramuscular Loxapine

NCT ID: NCT05324852

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-09
• Study Completion Date: 2024-04-23

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intranasal midazolam

Midazolam, 5 mg, injectable solution in 5mg/ml, if weight \< 50 kg : 5mg; if weight ≥50kg : 10mg, intranasal administration, atomize into nose with Mucosal Atomizer Device (MAD) 5mg(1ml) up each nostril , one time

Group Type: EXPERIMENTAL

Intranasal midazolam

Intervention Type: DRUG

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

Intramuscular loxapine

Loxapine, 100mg, injectable solution in 50mg/2ml intramuscular, intra muscular administration, one time

Group Type: ACTIVE_COMPARATOR

Intramuscular loxapine

Intervention Type: DRUG

Loxapine, 100mg, injectable solution in 50mg/2ml intramuscular, intra muscular administration, one time

Interventions

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

Intervention Type: DRUG

Intramuscular loxapine

Loxapine, 100mg, injectable solution in 50mg/2ml intramuscular, intra muscular administration, one time

Intervention Type: DRUG

Other Intervention Names

Midazolam; Loxapine

Eligibility Criteria

Inclusion Criteria

• Age 18 to 60 years;
• Agitated Patient whose somatic or psychiatric aetiology cannot be diagnosed in an emergency situation and who need a sedation in a hospital emergency setting due to the presence of unmanageable agitation with 3 major criteria.

Major criteria :

Agitation Pain Tolerance Tachypnea ( fr > 20)

And 1 minor criteria among :

Sweating Tactile Hyperthermia Medical care Non compliance Lack of tiring Unusual Strenght Inappropriately clothed, nudity

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from randomization into the study:

• Pregnancy
• Prisoners
• Contraindications to intranasal Midazolam or intramuscular Loxapine :

• Hypersensitivity to benzodiazepines or to any of the excipients (Sodium Chloride, Hydrochloric Acid, Sodium Hydroxide, Water for Injection)
• Known hypersensitivity to loxapine or to any of the excipients (Polysorbate 80, propylene glycol, 20% v/v hydrochloric acid, water for injections, Nitrogen (Inert gas)
• Individuals who are in comatose states or have central nervous system (CNS) depression due to alcohol or are taking other depressant drugs
• Individuals with severe depressive states, spastic diseases, and with Parkinson's disease, except in the case of dyskinesias due to levodopa treatment
• In combination with dopamine agonists except levodopa (amantadine, bromocriptine, lisuride, pergolide, piribedil, ropinirole, cabergoline, pramipexole, apomorphine) outside the patient with Parkinson's disease
• Individuals with a history of cerebrovascular accident or epilepsia
• Individuals in whom a significant elevation of blood pressure would constitute a serious hazard, such as patients with significant hypertension;
• Individuals with severe cardiac decompensation
• Patients with severe respiratory failure or acute respiratory depression
• Individuals with acute narrow angle glaucoma.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lariboisière-Saint Louis clinical research unit

UNKNOWN

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frédéric Adnet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Avicenne

Bobigny, , France

Countries

France

Other Identifiers

P160947J

Identifier Type: -

Identifier Source: org_study_id