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A Study of Staccato Loxapine (ADASUVE®) for Inhalation

NCT04148963 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-11-05

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Inhaled loxapine

Inhaled Loxapine 9.1 mg, may repeat x 1 or 2 after 2 hours

DRUG

Inhaled placebo

Inhaled placebo, may repeat x 1 or 2 after 2 hours

Sponsors & Collaborators

  • Lee's Pharmaceutical Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2020-05-01
Completion
2020-08-01
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04148963 on ClinicalTrials.gov