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Completed

NCT Number: NCT00628589

Staccato Loxapine in Agitated Patients With Schizophrenia

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

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Key information

Conditions

Patients With Schizophrenia and Acute Agitation Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Dyskinesias Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

About this study

This is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study of 2 dose levels of Staccato Loxapine, 5 and 10 mg. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female adult patients with schizophrenia and acute agitation

Exclusion criteria

  • Agitation caused primarily by acute intoxication
  • History of drug or alcohol dependence
  • Treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug administration

Treatment and study plan

inhaled Loxapine 5 mg

Drug

Inhaled loxapine 5 mg

Other names: ADASUVE

Inhaled loxapine 10 mg

Drug

Inhaled loxapine 10 mg

Other names: ADASUVE

Inhaled placebo

Drug

Inhaled placebo

Primary outcomes

  1. Change in PANSS-EC From Baseline

    Time frame: Baseline and 2 hours

    The Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (min) to 7 (max). The PANSS-EC, the sum of these 5 subscales, thus ranges from 5 to 35. Individuals were eligible if they had a PANSS-EC of ≥14 (out of 35) and a score ≥4 (out of 7) on at least 1 of the 5 items.

Secondary outcomes

  1. Clinical Global Impression-Improvement (CGI-I) Score

    Time frame: Baseline and 2 hours

    Clinical Global Impression- Improvement (CGI-I) scores ranged from 1 to 7: 0=not assessed (missing), 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.

  2. CGI-I Responders

    Time frame: Baseline and 2 hours

    Frequency of response based on the CGI-I (defined as achieving a CGI-I score of 1 or 2 at 2 hours after administration of the inhalation)

Sponsors and collaborators

Lead sponsor

Alexza Pharmaceuticals, Inc.

Unknown

Registry information

Official study title

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multi-Dose Efficacy and Safety Study of Staccato® Loxapine for Inhalation in Schizophrenic Patients With Agitation

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 5, 2008
Registry last updated
Jul 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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