Unknown PHASE3 INTERVENTIONAL 2-arm NCT04148963

A Study of Staccato Loxapine (ADASUVE®) for Inhalation

A Multi-center, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Staccato Loxapine (ADASUVE®) for Inhalation in Acutely Agitated Patients With Schizophrenia or Bipolar Disorder

Sponsor: Lee's Pharmaceutical Limited

Conditions Bipolar Disorder Psychomotor Agitation Schizophrenia

Interventions Inhaled loxapine Inhaled placebo

Updated 5 times since 2019 Last updated: Nov 4, 2019 Started: Dec 1, 2019 Primary completion: May 1, 2020 Completion: Aug 1, 2020

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04148963, this PHASE3 trial focuses on Bipolar Disorder and Psychomotor Agitation and remains ongoing. Sponsored by Lee's Pharmaceutical Limited, it has been updated 5 times since 2019, reflecting limited change activity. Mental health research at this phase helps define safety and dosing parameters for future study.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Unknown PHASE3
Jul 2024 — Sep 2024 [monthly]

Unknown PHASE3

Status: Unknown Status → Unknown
Feb 2021 — Jul 2024 [monthly]

Unknown Status PHASE3

Status: Not Yet Recruiting → Unknown Status
Jan 2021 — Feb 2021 [monthly]

Not Yet Recruiting PHASE3
Dec 2019 — Jan 2021 [monthly]

Not Yet Recruiting PHASE3

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Lee's Pharmaceutical Limited

Data source: Lee's Pharmaceutical Limited

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.