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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Psychomotor Agitation
• Schizophrenia
• Bipolar Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-12-01
• Primary completion: 2020-05-01
• Completion: 2020-08-01
• First posted: 2019-11-04
• Last updated: 2019-11-05

Regulatory

• FDA-regulated drug study