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Staccato Loxapine in Agitated Patients With Schizophrenia

Primary Purpose

Patients With Schizophrenia and Acute Agitation

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Inhaled loxapine 5 mg
Inhaled loxapine 10 mg
Inhaled placebo
Sponsored by
Alexza Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Schizophrenia and Acute Agitation focused on measuring schizophrenia, agitation, inhaled loxapine, ADASUVE

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Atlanta Center for Medical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Inhaled Loxapine 5 mg

Inhaled Loxapine 10 mg

Inhaled placebo

Arm Description

Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours

Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours

Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours

Outcomes

Primary Outcome Measures

Change in PANSS-EC From Baseline
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

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

Full Information

First Posted
February 25, 2008
Last Updated
June 28, 2017
Sponsor
Alexza Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00628589
Brief Title
Staccato Loxapine in Agitated Patients With Schizophrenia
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 Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexza Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Schizophrenia and Acute Agitation
Keywords
schizophrenia, agitation, inhaled loxapine, ADASUVE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
344 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inhaled Loxapine 5 mg
Arm Type
Experimental
Arm Description
Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
Arm Title
Inhaled Loxapine 10 mg
Arm Type
Experimental
Arm Description
Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
Arm Title
Inhaled placebo
Arm Type
Placebo Comparator
Arm Description
Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
Intervention Type
Drug
Intervention Name(s)
Inhaled loxapine 5 mg
Other Intervention Name(s)
ADASUVE
Intervention Description
Inhaled loxapine 5 mg
Intervention Type
Drug
Intervention Name(s)
Inhaled loxapine 10 mg
Other Intervention Name(s)
ADASUVE
Intervention Description
Inhaled loxapine 10 mg
Intervention Type
Drug
Intervention Name(s)
Inhaled placebo
Intervention Description
Inhaled placebo
Primary Outcome Measure Information:
Title
Change in PANSS-EC From Baseline
Description
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.
Time Frame
Baseline and 2 hours
Secondary Outcome Measure Information:
Title
Clinical Global Impression-Improvement (CGI-I) Score
Description
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.
Time Frame
Baseline and 2 hours
Title
CGI-I Responders
Description
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)
Time Frame
Baseline and 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S Fishman, MD
Organizational Affiliation
Alexza Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com
Citations:
PubMed Identifier
21200077
Citation
Lesem MD, Tran-Johnson TK, Riesenberg RA, Feifel D, Allen MH, Fishman R, Spyker DA, Kehne JH, Cassella JV. Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine. Br J Psychiatry. 2011 Jan;198(1):51-8. doi: 10.1192/bjp.bp.110.081513.
Results Reference
background
PubMed Identifier
29163985
Citation
Zeller S, Zun L, Cassella JV, Spyker DA, Yeung PP. Response to inhaled loxapine in patients with schizophrenia or bipolar I disorder: PANSS-EC responder analyses. BJPsych Open. 2017 Nov 10;3(6):285-290. doi: 10.1192/bjpo.bp.117.005363. eCollection 2017 Nov.
Results Reference
derived

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Staccato Loxapine in Agitated Patients With Schizophrenia

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