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Staccato Loxapine in Agitation (Proof of Concept)

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ClinicalTrials.gov Identifier: NCT00369577
Recruitment Status : Completed
First Posted : August 29, 2006
Results First Posted : January 2, 2018
Last Update Posted : January 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: Inhaled Placebo
Drug: Inhaled Loxapine 5 mg
Drug: Inhaled Loxapine 10 mg

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 19 centers between Sep-2006 and Jan-2007. Patients recruited for screening were: 1) admitted to a hospital or research unit with acute agitation, 2) inpatients being treated for chronic underlying conditions who presented with acute agitation, and 3) patients with agitation treated in a psychiatric ED.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Pre-Treatment Period was defined as the period immediately prior to dosing in which screening procedures and inclusion/exclusion criteria were used to evaluate all patients for eligibility to participate in the study.

Reporting Groups
  Description
Inhaled Placebo Inhaled Staccato Placebo, single dose
Inhaled Loxapine 5 mg Inhaled Staccato Loxapine 5 mg, single dose
Inhaled Loxapine 10 mg Inhaled Staccato Loxapine 10 mg, single dose

Participant Flow:   Overall Study
    Inhaled Placebo   Inhaled Loxapine 5 mg   Inhaled Loxapine 10 mg
STARTED   43   45   41 
COMPLETED   43   45   40 
NOT COMPLETED   0   0   1 
Withdrawal by Subject                0                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Inhaled Placebo Inhaled Staccato Placebo, single dose
Inhaled Loxapine 5 mg Inhaled Staccato Loxapine 5 mg, single dose
Inhaled Loxapine 10 mg Inhaled Staccato Loxapine 10 mg, single dose
Total Total of all reporting groups

Baseline Measures
   Inhaled Placebo   Inhaled Loxapine 5 mg   Inhaled Loxapine 10 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 43   45   41   129 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      43 100.0%      45 100.0%      41 100.0%      129 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.5  (7.7)   40.8  (7.45)   39.3  (8.77)   41.2  (8.09) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      10  23.3%      7  15.6%      7  17.1%      24  18.6% 
Male      33  76.7%      38  84.4%      34  82.9%      105  81.4% 
Region of Enrollment 
[Units: Participants]
       
United States   43   45   41   129 


  Outcome Measures

1.  Primary:   PANSS-EC Change From Baseline   [ Time Frame: 2 hours ]

2.  Secondary:   BARS Change From Baseline After Drug Treatment   [ Time Frame: 2 hours ]

3.  Secondary:   Clinical Global Impressions-Improvement Scale (CGI-I) After Drug Administration   [ Time Frame: 2 hours ]

4.  Secondary:   CGI-I Responders   [ Time Frame: 2 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Because of the need to provide informed consent, the types of patients enrolled in the study may not have been representative of the most severely agitated patients who present for emergency care.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Executive VP, Research & Development, Regulatory & Quality
Organization: Alexza Pharmaceuticals, Inc
phone: 650.944.7071
e-mail: ClinicalTrialsInfo@alexza.com


Publications of Results:

Responsible Party: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00369577     History of Changes
Other Study ID Numbers: AMDC-004-201
004-201
First Submitted: August 25, 2006
First Posted: August 29, 2006
Results First Submitted: January 30, 2017
Results First Posted: January 2, 2018
Last Update Posted: January 2, 2018