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Staccato Loxapine in Migraine (Out Patient)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00825500
First received: January 19, 2009
Last updated: March 13, 2017
Last verified: August 2009
Results First Received: March 13, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator;   Primary Purpose: Treatment
Condition: Migraine Headache
Interventions: Drug: Inhaled Placebo
Drug: Inhaled Loxapine 1.25 mg
Drug: Inhaled Loxapine 2.5 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Inhaled Placebo

Inhaled Staccato Placebo (0 mg)

Inhaled Placebo: Inhaled Staccato placebo (0 mg)

Inhaled Loxapine 1.25 mg

Inhaled Staccato Loxapine 1.25 mg, single dose

Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose

Inhaled Loxapine 2.5 mg

Inhaled Staccato Loxapine 2.5 mg, single dose

Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose


Participant Flow:   Overall Study
    Inhaled Placebo   Inhaled Loxapine 1.25 mg   Inhaled Loxapine 2.5 mg
STARTED   125   121   120 
COMPLETED   125   121   120 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
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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.
Safety Population

Reporting Groups
  Description
Inhaled Placebo

Inhaled Staccato Placebo (0 mg)

Inhaled Placebo: Inhaled Staccato placebo (0 mg)

Inhaled Loxapine 1.25 mg

Inhaled Staccato Loxapine 1.25 mg, single dose

Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose

Inhaled Loxapine 2.5 mg

Inhaled Staccato Loxapine 2.5 mg, single dose

Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose

Total Total of all reporting groups

Baseline Measures
   Inhaled Placebo   Inhaled Loxapine 1.25 mg   Inhaled Loxapine 2.5 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 125   121   120   366 
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      125 100.0%      121 100.0%      120 100.0%      366 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.5  (12.14)   41.2  (12.19)   42  (12.74)   41.5  (12.33) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      88  70.4%      100  82.6%      41  34.2%      229  62.6% 
Male      37  29.6%      21  17.4%      79  65.8%      137  37.4% 
Region of Enrollment 
[Units: Participants]
       
United States   125   121   120   366 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pain-Relief at 2 Hours Post-treatment   [ Time Frame: 2 hours ]

2.  Secondary:   Photophobia Free   [ Time Frame: 2 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  More Information
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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: Chief Scientific Officer
Organization: Alexza Pharmaceuticals, Inc
phone: 650.944.7777
e-mail: jcassella@alexza.com



Responsible Party: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00825500     History of Changes
Other Study ID Numbers: AMDC-104-202
24-October-2008
Study First Received: January 19, 2009
Results First Received: March 13, 2017
Last Updated: March 13, 2017