A Study of Staccato Loxapine (ADASUVE®) for Inhalation

Status Not yet recruiting

Clinical Trial Summary

Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic or bipolar disorder patients.

Clinical Trial Description

This is a multi-center, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of Staccato Loxapine or placebo in treating acute agitation in patients with schizophrenia or bipolar disorder (manic or mixed episodes) as defined by DSM-V criteria.Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. The primary endpoint is the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component (also known as PEC) score, performed at 2 hours after the first dose. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04148963
Study type	Interventional
Source	Lee's Pharmaceutical Limited
Contact
Status	Not yet recruiting
Phase	Phase 3
Start date	December 1, 2019
Completion date	August 1, 2020

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