AGItated Patients Management: intraNASAL Midazolam vs Intramuscular Loxapine

Last updated: May 23, 2024
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Terminated

Phase

3

Condition

N/A

Treatment

Intramuscular loxapine

Intranasal midazolam

Clinical Study ID

NCT05324852
P160947J
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 to 60 years;

  • Agitated Patient whose somatic or psychiatric aetiology cannot be diagnosed in anemergency situation and who need a sedation in a hospital emergency setting due tothe 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

• Medical insurance The protocol can start if the THREE major inclusion criteria and ONE of the minor inclusion criteria are checked PRESENT and ALL the non-inclusion criteria are checked no.

Exclusion

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 (SodiumChloride, 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 withParkinson's disease, except in the case of dyskinesias due to levodopatreatment

  • 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 constitutea 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.

Study Design

Total Participants: 1
Treatment Group(s): 2
Primary Treatment: Intramuscular loxapine
Phase: 3
Study Start date:
April 09, 2023
Estimated Completion Date:
April 23, 2024

Study 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.

Connect with a study center

  • Hôpital Avicenne

    Bobigny, 93000
    France

    Site Not Available

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