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Staccato Loxapine in Agitated Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00628589
Recruitment Status : Completed
First Posted : March 5, 2008
Results First Posted : June 29, 2017
Last Update Posted : July 26, 2017
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Patients With Schizophrenia and Acute Agitation Drug: Inhaled loxapine 5 mg Drug: Inhaled loxapine 10 mg Drug: Inhaled placebo Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 344 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : February 2008
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Arm Intervention/treatment
Experimental: Inhaled Loxapine 5 mg
Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
Drug: Inhaled loxapine 5 mg
Inhaled loxapine 5 mg
Other Name: ADASUVE

Experimental: Inhaled Loxapine 10 mg
Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
Drug: Inhaled loxapine 10 mg
Inhaled loxapine 10 mg
Other Name: ADASUVE

Placebo Comparator: Inhaled placebo
Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
Drug: Inhaled placebo
Inhaled placebo

Primary Outcome Measures :
  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 Outcome Measures :
  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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00628589

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United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
Sponsors and Collaborators
Alexza Pharmaceuticals, Inc.
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Study Director: Robert S Fishman, MD Alexza Pharmaceuticals, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00628589    
Other Study ID Numbers: AMDC-004-301
First Posted: March 5, 2008    Key Record Dates
Results First Posted: June 29, 2017
Last Update Posted: July 26, 2017
Last Verified: June 2008
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexza Pharmaceuticals, Inc.:
schizophrenia, agitation, inhaled loxapine, ADASUVE
Additional relevant MeSH terms:
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Psychomotor Agitation
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action