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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
Sponsor:
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE February 25, 2008
First Posted Date  ICMJE March 5, 2008
Results First Submitted Date  ICMJE February 4, 2017
Results First Posted Date  ICMJE June 29, 2017
Last Update Posted Date July 26, 2017
Study Start Date  ICMJE February 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2017)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 25, 2008)		 Change in PANSS Excited Component (PEC) score from baseline following Dose #1 of Staccato Loxapine, compared with placebo [ Time Frame: 2 hr ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2017)
  • 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.
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2008)
  • Clinical Global Impression-Improvement (CGI-I) score following Dose #1 of Staccato Loxapine, compared with placebo [ Time Frame: 2 hr ]
  • Treatment emergent adverse events, compared with placebo [ Time Frame: 24 hr ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Staccato Loxapine in Agitated Patients With Schizophrenia
Official Title  ICMJE A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multi-Dose Efficacy and Safety Study of Staccato® Loxapine for Inhalation in Schizophrenic Patients With Agitation
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Patients With Schizophrenia and Acute Agitation
Intervention  ICMJE
  • Drug: Inhaled loxapine 5 mg
    Inhaled loxapine 5 mg
    Other Name: ADASUVE
  • Drug: Inhaled loxapine 10 mg
    Inhaled loxapine 10 mg
    Other Name: ADASUVE
  • Drug: Inhaled placebo
    Inhaled placebo
Study Arms  ICMJE
  • Experimental: Inhaled Loxapine 5 mg
    Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours
    Intervention: Drug: Inhaled loxapine 5 mg
  • Experimental: Inhaled Loxapine 10 mg
    Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours
    Intervention: Drug: Inhaled loxapine 10 mg
  • Placebo Comparator: Inhaled placebo
    Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
    Intervention: Drug: Inhaled placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2017)		 344
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2008)		 300
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00628589
Other Study ID Numbers  ICMJE AMDC-004-301
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Current Responsible Party Alexza Pharmaceuticals, Inc.
Original Responsible Party Robert S. Fishman, MD, FCCP; Vice President, Medical Affairs, Alexza Pharmaceuticals, Inc
Current Study Sponsor  ICMJE Alexza Pharmaceuticals, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robert S Fishman, MD Alexza Pharmaceuticals, Inc.
PRS Account Alexza Pharmaceuticals, Inc.
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP