Frontlight ResearchEarly access
TerminatedPhase 3
AGItated Patients Management: intraNASAL Midazolam vs Intramuscular Loxapine
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- France1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- Phase
- Phase 3
- People taking part
- 1 person enrolled
- Started
- 9 Apr 2023
- Ended
- 23 Apr 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Intranasal midazolam
- Intramuscular loxapine
- Record updated
- 28 May 2024
- Why it stopped
- Sponsor decision:
Who can take part
- Age
- 18 years to 60 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
- 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
Who cannot take part
- 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
- Subjects who meet any of the following criteria will be excluded from randomization into the study:
- Pregnancy
- Prisoners
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Intranasal midazolamTreatment being tested
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
- Intramuscular loxapineExisting treatment, for comparison
Loxapine, 100mg, injectable solution in 50mg/2ml intramuscular, intra muscular administration, one time
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- AGItated Patients Management: intraNASAL Midazolam vs Intramuscular Loxapine, a Randomized Non Inferiority Trial
- Record updated
- 28 May 2024