At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Randomized, Double-blind, Placebo-controlled, Single Dose Efficacy and Safety Study of StaccatoTM Loxapine for Inhalation in Schizophrenic Patients With Agitation.
In Brief
A Phase 2 clinical trial evaluating Inhaled Placebo, Inhaled Loxapine 5 mg, and 1 other intervention for Schizophrenia. Completed, enrolled 129 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Inhaled Placebo, single dose
Inhaled Staccato Loxapine 5 mg, single dose
Inhaled Staccato Loxapine 10 mg, single dose