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Observational Study Evaluating the Safety of ADASUVE® in Agitation Associated With Schizophrenia or Bipolar I Disorder

NCT03513549 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2025-10-21

No results posted yet for this study

Summary

This postmarketing observational study will evaluate the safety of ADASUVE® in treating patients with agitation associated with schizophrenia or bipolar I disorder.

Conditions

  • Agitation,Psychomotor

Interventions

DRUG

Loxapine 10 MG

Sponsors & Collaborators

  • Pharmaceutical Research Associates

    collaborator OTHER

  • Alexza Pharmaceuticals, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-04
Primary Completion
2027-02-28
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03513549 on ClinicalTrials.gov