Patients may be very agitated during the weaning period from mechanical ventilation.
Administration of loxapine, a neuroleptic that does not notably affect ventilatory drive, may
help in obtaining an adequate level of cooperation and, therefore, in reducing the duration
of mechanical ventilation.
Randomized Double-blind Trial of Midazolam and Loxapine in Agitated Patients
Terminated
University Hospital, Rouen
Phase 3
2005-12-01
Neuroleptics are used since a long time in the management of severely agitated patients.
Loxapine is routinely used in our country, with, to our knowledge no severe adverse event
reported, in this indication.
However, recently, benzodiazepines have appeared interesting in agitated patients, with the
use of midazolam.
The aim of this study is to compare midazolam to loxapine in the treatment of severe agitated
patients admitted in the emergency department.
The purpose of this study is to assess efficacy and safety of Staccato Loxapine in the
treatment of acute agitation in schizophrenic patients. The study will be conducted in 120
agitated schizophrenic patients - either newly admitted to a hospital setting or a research
unit for acute agitation or already in hospital for chronic underlying conditions. Patients
meeting entry criteria will be randomized to one of two doses of Staccato Loxapine or to
Staccato Placebo. Following administration of study drug, assessment of agitation state will
be conducted at serial time points using standard agitation scales over a 24 hour period.
The objective of this study was to assess the safety, tolerability and pharmacokinetics of a
single inhaled dose of (administered in 1 or 2 puffs) Staccato Loxapine in healthy
volunteers.
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